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This systematic review aimed to synthesize evidence on predictors and moderators of treatment outcomes in internet- and mobile-based interventions (IMIs) for depression, informing personalized care. A systematic search across PubMed, PsycInfo, and Cochrane yielded 33,002 results. Two reviewers independently performed screening, data extraction, risk of bias assessment, and methodological quality evaluation. Fifty-eight single studies (m = 466 analyses) focusing on baseline-predictors (59.7 %, m = 278), process-predictors (16.5 %, m = 77), and moderators (21.9 %, m = 102), and six individual patient data meta-analyses (m = 93) were included. Only 24.0 % (m = 112/466) of analyses in single studies and 15.1 % (m = 14/93) in individual patient data meta-analyses were significant. Evidence from single studies was rated as insufficient for all variable categories with only 2 out of 40 categories showing >50 % significant results. Baseline depression severity had the strongest predictive value with higher scores linked to better outcomes followed by variables indicative for the course-of-change. Other frequently analyzed and potentially relevant variables with significant results were adherence, age, educational level, ethnicity, relationship status, treatment history, and behavioral variables. More high quality quantitative studies with sufficient power are essential to validate and expand findings, identifying predictors and moderators specifically relevant in IMIs to explain differential treatment effects., Competing Interests: A.Z. reports fees for presentations at scientific meetings and for expert videos for an internet-based intervention. D.E. has served as a consultant to/on the scientific advisory boards of Sanofi, Novartis, Minddistrict, Lantern, Schoen Kliniken, Ideamed, and German health insurance companies (BARMER, Techniker Krankenkasse) and a number of federal chambers for psychotherapy. He is also a stakeholder in the institute for health training online (formerly GET.ON, now HelloBetter), which aims to implement scientific findings related to digital health interventions in routine care. H.B. reports to have received consultancy fees, fees for lectures or workshops from chambers of psychotherapists and training institutes for psychotherapists and license fees for an Internet-intervention. P.C., T.S., and M.S. report no conflicts of interest., (© 2024 The Authors.)

Introduction: Farmers have a high risk for depression (MDD). Preventive measures targeting this often remotely living population might reduce depression burden. The study aimed to evaluate the effectiveness of personalized telephone coaching in reducing depressive symptom severity and preventing MDD in farmers compared to enhanced treatment as usual (TAU + )., Methods: In a two-armed, pragmatic randomized controlled trial ( N  = 314) with post-treatment at 6 months, farming entrepreneurs, collaborating family members and pensioners with elevated depressive symptoms (PHQ-9 ≥ 5) were randomized to personalized telephone coaching or TAU + . The coaching was provided by psychologists and consists on average of 13 (±7) sessions a 48 min (±15) over 6 months. The primary outcome was depressive symptom severity (QIDS-SR16)., Results: Coaching participants showed a significantly greater reduction in depressive symptom severity compared to TAU + ( d  = 0.39). Whereas reliable symptom deterioration was significantly lower in the intervention group compared to TAU + , no significant group differences were found for reliable improvement and in depression onset. Further significant effects in favor of the intervention group were found for stress ( d  = 0.34), anxiety ( d  = 0.30), somatic symptoms ( d  = 0.39), burnout risk ( d  = 0.24-0.40) and quality of life ( d  = 0.28)., Discussion: Limiting, we did not apply an upper cutoff score for depressive symptom severity or controlled for previous MDD episodes, leaving open whether the coaching was recurrence/relapse prevention or early treatment. Nevertheless, personalized telephone coaching can effectively improve mental health in farmers. It could play an important role in intervening at an early stage of mental health problems and reducing disease burden related to MDD., Trial Registration Number and Trial Register: German Clinical Trial Registration: DRKS00015655., Competing Interests: Data availabilityAccess to the final pseudonomized trial dataset can be provided to fellow researchers upon request, depending on to be specified data security and data exchange regulation agreements. Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DDE has served as a consultant to/on the scientific advisory boards of Sanofi, Novartis, Minddistrict, Lantern, Schoen Kliniken, Ideamed, and German health insurance companies (BARMER, Techniker Krankenkasse) and a number of federal chambers for psychotherapy. DDE and MB are stakeholders of the Institute for health training online (GET.ON/HelloBetter), which aims to implement scientific findings related to digital health interventions into routine care. MB is scientific advisor of mentalis GmbH, a provider for digital aftercare. HB reports having received consultancy fees and fees for lectures/workshops from chambers of psychotherapists and training institutes for psychotherapists in the e-mental-health context. IT reports having received fees for lectures/workshops in the e-mental-health context from training institutes for psychotherapists. She was the research and implementation project lead of the trial site Institute for health training online (GET.ON) for the European implementation research project ImpleMentAll (11/2017-03/2021) funded by the European Commission.

Background: Insomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined., Methods: This study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment)., Discussion: The widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions. If this trial demonstrates the non-inferiority of therapist-guided iCBT-I, healthcare providers may be more confident recommending this treatment to their patients, contributing to the wider dissemination of CBT-I., Trial Registration: Trial registration number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023., (© 2024. The Author(s).)

Background: Blurred work-non-work boundaries can have negative effects on mental health, including sleep., Objectives: In a randomised control trial, we aimed to assess the effectiveness of an online recovery training programme designed to improve symptoms of insomnia in a working population exposed to blurred boundaries., Methods: 128 participants with severe insomnia symptoms (Insomnia Severity Index ≥15) and working under blurred work and non-work conditions (segmentation supplies <2.25) were randomly assigned to either the recovery intervention or a waitlist control group (WLC). The primary outcome was insomnia severity, assessed at baseline, after 2 months (T2) and 6 months (T3)., Findings: A greater reduction in insomnia was observed in the intervention compared with the WLC group at both T2 ( d =1.51; 95% CI=1.12 o 1.91) and T3 ( d =1.63; 95% CI=1.23 to 2.03]. This was shown by Bayesian analysis of covariance (ANCOVA), whereby the ANCOVA model yielded the highest Bayes factor ( BF 10 =3.23×e 60 ] and a 99.99% probability. Likewise, frequentist analysis revealed significantly reduced insomnia at both T2 and T3. Beneficial effects were found for secondary outcomes including depression, work-related rumination, and mental detachment from work. Study attrition was 16% at T2 and 44% at T3., Conclusions: The recovery training was effective in reducing insomnia symptoms, work related and general indicators of mental health in employees exposed to blurred boundaries, both at T2 and T3., Clinical Implications: In addition to demonstrating the intervention's effectiveness, this study exemplifies the utilisation of the Bayesian approach in a clinical context and shows its potential to empower recipients of interventional research by offering insights into result probabilities, enabling them to draw informed conclusions., Trial Registration Number: German Clinical Trial Registration (DRKS): DRKS00006223, https://drks.de/search/de/trial/DRKS00006223., Competing Interests: Competing interests: HH and DDE are stakeholders of the ‘Institute for Online Health Trainings’, a company that aims to transfer scientific knowledge, including the present intervention, into routine occupational health care. HB, SW and DL have reported no conflicts of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. Published by BMJ.)

Objective This open-trial study examined effects of a culturally-adapted Hebrew version of guided internet-based cognitive behavioural therapy (ICBT) for depression. We examined therapeutic alliance with the therapist and with the programme (content) as potential predictors of outcomes. Furthermore, we examined whether anxious and avoidant attachment styles improved, although relationships were not the focus of treatment. Method: We examined alliance with therapist and alliance with programme and their time-lagged (1 week), longitudinal relationship with depression outcomes, and change in anxious and avoidant attachment during treatment. Results: Depression and insomnia improved significantly (Cohen's d : depression = 1.34, insomnia = 0.86), though dropout was relatively high (49%). Alliance with programme and with the therapist predicted adherence and dropout, whereas only alliance with therapist predicted symptom improvement. Avoidant attachment decreased over treatment whereas anxious attachment did not. Conclusion: A culturally-adapted version of ICBT for depression showed that alliance with therapist and alliance with programme both can play an important role in its effectiveness: alliance with programme and the therapist drive adherence and dropout and alliance with therapist is related to symptom improvement. Although the focus of treatment is not interpersonal, avoidant attachment style can improve following ICBT.

Clinical observations suggest that individuals with panic disorder (PD) vary in their beliefs about the causes of their panic attacks. Some attribute these attacks to psychological factors, while others to physiological or medical factors. These beliefs also extend to whether individuals perceive panic attacks as dangerous. In other areas of psychiatric nosology, these phenomena are commonly called clinical insight (recognition of disorder and the need for treatment) and cognitive insight (the ability to reflect on one's beliefs). Despite its importance, limited research exists on insight in PD and its relation to symptoms and treatment outcomes. This study examines clinical and cognitive insight in 83 patients with PD who received internet-based cognitive behavioral therapy, investigating their relationship with symptoms, treatment outcomes, and changes in insight. We assessed patients using interview and self-report measures of insight and symptoms. Clinical and cognitive insight were correlated and both constructs improved significantly during treatment. Good clinical insight pretreatment was positively correlated with more severe pretreatment symptoms. Pretreatment clinical and cognitive insight were not correlated with symptom change or attrition. Greater change in clinical and cognitive insight was related to greater change in symptoms. The findings highlight the significance of clinical and cognitive insight in PD, and the importance of distinguishing between them. This suggests the need to develop interventions according to patients' level of insight, particularly focusing on those lacking insight. Further research is essential to advance our understanding of the relationship between insight and the phenomenology and treatment of PD., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Objective: Digital stress interventions could be helpful as an "indirect" treatment for depression, but it remains unclear for whom this is a viable option. In this study, we developed models predicting individualized benefits of a digital stress intervention on depressive symptoms at 6-month follow-up., Method: Data of N = 1,525 patients with depressive symptoms (Center for Epidemiological Studies' Depression Scale, CES-D ≥ 16) from k = 6 randomized trials (digital stress intervention vs. waitlist) were collected. Prognostic models were developed using multilevel least absolute shrinkage and selection operator and boosting algorithms, and were validated using bootstrap bias correction and internal-external cross-validation. Subsequently, expected effects among those with and without a treatment recommendation were estimated based on clinically derived treatment assignment cut points., Results: Performances ranged from R ² = 21.0%-23.4%, decreasing only slightly after model optimism correction ( R ² = 17.0%-19.6%). Predictions were greatly improved by including an interim assessment of depressive symptoms (optimism-corrected R2 = 32.6%-35.6%). Using a minimally important difference of d = -0.24 as assignment cut point, approximately 84.6%-93.3% of patients are helped by this type of intervention, while the remaining 6.7%-15.4% would experience clinically negligible benefits (δ^ = -0.02 to -0.19). Using reliable change as cut point, a smaller subset (39.3%-46.2%) with substantial expected benefits (δ^ = -0.68) receives a treatment recommendation., Conclusions: Meta-analytic prognostic models applied to individual participant data can be used to predict differential benefits of a digital stress intervention as an indirect treatment for depression. While most patients seem to benefit, the developed models could be helpful as a screening tool to identify those for whom a more intensive depression treatment is needed. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Background: Major depressive disorder (MDD) is highly prevalent and burdensome for individuals and society. While there are psychological interventions able to prevent and treat MDD, uptake remains low. To overcome structural and attitudinal barriers, an indirect approach of using online insomnia interventions seems promising because insomnia is less stigmatized, predicts MDD onset, is often comorbid and can outlast MDD treatment. This individual-participant-data meta-analysis evaluated the potential of the online insomnia intervention GET.ON Recovery as an indirect treatment to reduce depressive symptom severity (DSS) and potential MDD onset across a range of participant characteristics., Methods: Efficacy on depressive symptom outcomes was evaluated using multilevel regression models controlling for baseline severity. To identify potential effect moderators, clinical, sociodemographic, and work-related variables were investigated using univariable moderation and random-forest methodology before developing a multivariable decision tree., Results: IPD were obtained from four of seven eligible studies ( N = 561); concentrating on workers with high work-stress. DSS was significantly lower in the intervention group both at post-assessment ( d = -0.71 [95% CI-0.92 to -0.51]) and at follow-up ( d = -0.84 [95% CI -1.11 to -0.57]). In the subsample ( n = 121) without potential MDD at baseline, there were no significant group differences in onset of potential MDD. Moderation analyses revealed that effects on DSS differed significantly across baseline severity groups with effect sizes between d = -0.48 and -0.87 (post) and d = - 0.66 to -0.99 (follow-up), while no other sociodemographic, clinical, or work-related characteristics were significant moderators., Conclusions: An online insomnia intervention is a promising approach to effectively reduce DSS in a preventive and treatment setting.

Question: Depression is highly prevalent and associated with numerous adverse consequences for both individuals and society. Due to low uptake of direct treatment, interventions that target related, but less stigmatising problems, such as perceived stress, have emerged as a new research paradigm.This individual participant data (IPD) meta-analysis examines if a web-based stress management intervention can be used as an 'indirect' treatment of depression., Study Selection and Analysis: Bayesian one-stage models were used to estimate pooled effects on depressive symptom severity, minimally important improvement and reliable deterioration. The dose-response relationship was examined using multilevel additive models, and IPD network meta-analysis was employed to estimate the effect of guidance., Findings: In total, N=1235 patients suffering from clinical-level depression from K=6 randomised trials were included. Moderate-to-large effects were found on depressive symptom severity at 7 weeks post-intervention (d=-0.65; 95% credibility interval (CrI): -0.84 to -0.48) as measured with the Center for Epidemiological Studies' Depression Scale. Effects were sustained at 3-month follow-up (d=-0.74; 95% CrI: -1.01 to -0.48). Post-intervention symptom severity was linearly related to the number of completed sessions. The incremental impact of guidance was estimated at d=-0.25 (95% CrI: -1.30 to 0.82), with a 35% posterior probability that guided and unguided formats produce equivalent effects., Conclusions: Our results indicate that web-based stress management can serve as an indirect treatment, yielding effects comparable with direct interventions for depression. Further research is needed to determine if such formats can indeed increase the utilisation of evidence-based treatment, and to corroborate the favourable effects for human guidance., Study Registration: Open material repository: osf.io/dbjc8, osf.io/3qtbe., Trial Registration Number: German Clinical Trial Registration (DRKS): DRKS00004749, DRKS00005112, DRKS00005384, DRKS00005687, DRKS00005699, DRKS00005990., Competing Interests: Competing interests: DDE reports to have received consultancy fees or served in the scientific advisory board from several companies such as Novartis, Sanofi, Lantern, Schön Kliniken, Minddistrict and German health insurance companies (BARMER, Techniker Krankenkasse). DDE and EH are stakeholders and MH is a part-time employee of the Institute for Health Trainings Online (GET.ON), which aims to implement scientific findings related to digital health interventions into routine care., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. Published by BMJ.)

Background: GET.ON (HelloBetter) treatment interventions have been shown to be efficacious in multiple randomized controlled trials., Objective: This study evaluated the effectiveness of 2 GET.ON interventions, GET.ON Mood Enhancer and GET.ON Stress, in a national digital mental health service implemented across Germany., Methods: Following an initial web-based questionnaire, participants were allocated to either intervention based on their baseline symptom severity and personal choice and received a semistandardized guided, feedback-on-demand guided, or self-guided version of the treatment. Uncontrolled routine care data from 851 participants were analyzed using a pretest-posttest design. Half of the participants (461/851, 54.2%) were allocated to the stress intervention (189/461, 41% semistandardized; 240/461, 52% feedback on demand; and 32/461, 6.9% self-guided), and almost all participants in the mood intervention (349/352, 99.2%) received semistandardized guidance., Results: Results on depression-related symptom severity indicated a reduction in reported symptoms, with a large effect size of d=-0.92 (95% CI -1.21 to -0.63). Results on perceived stress and insomnia indicated a reduction in symptom severity, with large effect sizes of d=1.02 (95% CI -1.46 to -0.58) and d=-0.75 (95% CI -1.10 to -0.40), respectively. A small percentage of participants experienced deterioration in depression-related symptoms (11/289, 3.8%), perceived stress (6/296, 2%), and insomnia (5/252, 2%). After completing treatment, 51.9% (150/289) of participants showed a clinically reliable change in depression-related symptoms, whereas 20.4% (59/289) achieved a close to symptom-free status. Similar improvements were observed in perceived stress and insomnia severity. Guidance moderated the effectiveness of and adherence to the interventions in reducing depressive symptom severity. Effect sizes on depression-related symptom severity were d=-1.20 (95% CI -1.45 to -0.93) for the semistandardized group, d=-0.36 (95% CI -0.68 to -0.04) for the feedback-on-demand group, and d=-0.83 (95% CI -1.03 to -0.63) for the self-guided group. Furthermore, 47.6% (405/851) of the participants completed all modules of the intervention. Participant satisfaction was high across all patient groups and both interventions; 89.3% (242/271) of participants would recommend it to a friend in need of similar help. Limitations include the assignment to treatments and guidance formats based on symptom severity. Furthermore, part of the differences in symptom change between groups must be assumed to be due to this baseline difference in the measures., Conclusions: Future digital health implementation and routine care research should focus on monitoring symptom deterioration and other negative effects, as well as possible predictors of deterioration and the investigation of individual patient trajectories. In conclusion, this study supports the effectiveness of tailored digital mental health services in routine care for depression- and stress-related symptoms in Germany. The results highlight the importance of guidance in delivering internet-based cognitive behavioral therapy interventions and provide further evidence for its potential delivered as web-only solutions for increasing access to and use of psychological treatments., (©Anne Etzelmueller, Elena Heber, Hanne Horvath, Anna Radkovsky, Dirk Lehr, David Daniel Ebert. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 01.02.2024.)

Background: Many youth with posttraumatic stress symptoms (PTSS) do not receive evidence-based care. Internet- and Mobile-Based Interventions (IMIs) comprising evidence-based trauma-focused components can address this gap, but research is scarce. Thus, we investigated the feasibility of a trauma-focused IMI for youth with PTSS. Methods: In a one-arm non-randomized prospective proof-of-concept study, 32 youths aged 15-21 years with clinically relevant PTSS (CATS ≥ 21) received access to a trauma-focused IMI with therapist guidance, comprising nine sessions on an eHealth platform accessible via web-browser. We used a feasibility framework assessing recruitment capability, sample characteristics, data collection, satisfaction, acceptability, study management abilities, safety aspects, and efficacy of the IMI in PTSS severity and related outcomes. Self-rated assessments took place pre-, mid-, post-intervention and at 3-month follow-up and clinician-rated assessments at baseline and post-intervention. Results: The sample mainly consisted of young adult females with interpersonal trauma and high PTSS levels (CATS, M  = 31.63, SD  = 7.64). The IMI sessions were found useful and comprehensible, whereas feasibility of trauma processing was perceived as difficult. Around one-third of participants (31%) completed the IMI's eight core sessions. The study completer analysis showed a significant reduction with large effects in self-rated PTSS at post-treatment [ t (21) = 4.27; p  < .001; d  = 0.88] and follow-up [ t (18) = 3.83; p  = .001; d  = 0.84], and clinician-rated PTSD severity at post-treatment [ t (21) = 4.52; p  < .001; d  = 0.93]. The intention-to-treat analysis indicated significant reductions for PTSS at post-treatment and follow-up with large effect sizes ( d  = -0.97- -1.02). All participants experienced at least one negative effect, with the most common being the resurfacing of unpleasant memories ( n  = 17/22, 77%). Conclusion: The study reached highly burdened young adults. The IMI was accepted in terms of usefulness and comprehensibility but many youths did not complete all sessions. Exploration of strategies to improve adherence in trauma-focused IMIs for youth is warranted, alongside the evaluation of the IMI's efficacy in a subsequent randomized controlled trial.

Introduction: Limited research exists on intervention efficacy for comorbid subclinical anxiety and depressive disorders, despite their common co-occurrence. Internet- and mobile-based interventions (IMIs) are promising to reach individuals facing subclinical symptoms., Objective: This study aimed to evaluate the efficacy of a transdiagnostic and self-tailored IMI in reducing subclinical anxiety and depressive symptom severity with either individualized (IG-IMI) or automated (AG-IMI) guidance compared to a waitlist control group with care-as-usual access (WLC)., Methods: Participants included 566 adults with subclinical anxiety (GAD-7 ≥ 5) and/or depressive (CES-D ≥16) symptoms, who did not meet criteria for a full-syndrome depressive or anxiety disorder. In a three-arm randomized clinical trial, participants were randomized to a cognitive behavioral 7-session IMI plus booster session with IG-IMI (n = 186) or AG-IMI (n = 189) or WLC (n = 191). Primary outcomes included observer-rated anxiety (HAM-A) and depressive (QIDS) symptom severity 8 weeks after randomization assessed by blinded raters via telephone. Follow-up outcomes at 6 and 12 months are reported., Results: Symptom severity was significantly lower with small to medium effects in IG-IMI (anxiety: d = 0.45, depression: d = 0.43) and AG-IMI (anxiety: d = 0.31, depression: d = 0.32) compared to WLC. No significant differences emerged between guidance formats in primary outcomes. There was a significant effect in HAM-A after 6 months favoring AG-IMI. On average, participants completed 85.38% of IG-IMI and 77.38% of AG-IMI., Conclusions: A transdiagnostic, self-tailored IMI can reduce subclinical anxiety and depressive symptom severity, but 12-month long-term effects were absent. Automated guidance holds promise for enhancing the scalability of IMIs in broad prevention initiatives., (© 2024 The Author(s). Published by S. Karger AG, Basel.)

Background: The implementation trial BESTFORCAN aims to evaluate the dissemination of Trauma-Focused Behavioural Therapy (TF-CBT) for children and adolescents in Germany with posttraumatic stress symptoms (PTSS) after child abuse and neglect (CAN) with a focus on supervision. Objective: This update to the study protocol outlines changes made due to practical reasons in the course of the ongoing trial while maintaining methodological quality. Method: The amendments to the original study protocol comprise (1) a more refined operationalisation of the primary outcome sufficiently adherent TF-CBT therapy (SATT), (2) changes in the study sites and (3) additional inclusion of one post-gradual psychotherapy training institute. Discussion: The adaptions to the original study protocol ensured high methodological quality through the transparent presentation of protocol modification: ensuring the recruitment of participating psychotherapists in training by including a further post-gradual training institute as well as an adaption of the measurement of SATT with high external validity. The objectives, diagnostic set, and secondary outcomes remained unimpaired by the amendment. Therefore, we expect the trial to provide evidence for the effect of model-specific trauma-focused supervision on the implementation outcomes of TF-CBT as compared to supervision as usual. Trial registration: German Clinical Trials Register identifier: DRKS00020516..

Background: It is uncertain whether app-based interventions add value to existing mental health care., Objective: To examine the incremental effects of app-based interventions when used as adjunct to mental health interventions., Methods: We searched PubMed, PsycINFO, Scopus, Web of Science, and Cochrane Library databases on September 15th, 2023, for randomised controlled trials (RCTs) on mental health interventions with an adjunct app-based intervention compared to the same intervention-only arm for adults with mental disorders or respective clinically relevant symptomatology. We conducted meta-analyses on symptoms of different mental disorders at postintervention. PROSPERO, CRD42018098545., Results: We identified 46 RCTs (4869 participants). Thirty-two adjunctive app-based interventions passively or actively monitored symptoms and behaviour, and in 13 interventions, the monitored data were sent to a therapist. We found additive effects on symptoms of depression ( g  = 0.17; 95 % CI 0.02 to 0.33; k  = 7 comparisons), anxiety ( g  = 0.80; 95 % CI 0.06 to 1.54; k  = 3), mania ( g  = 0.2; 95 % CI 0.02 to 0.38; k  = 4), smoking cessation ( g  = 0.43; 95 % CI 0.29 to 0.58; k  = 10), and alcohol use ( g  = 0.23; 95 % CI 0.08 to 0.39; k  = 7). No significant effects were found on symptoms of depression within a bipolar disorder ( g  = -0.07; 95 % CI -0.37 to 0.23, k  = 4) and eating disorders ( g  = -0.02; 95 % CI -0.44 to 0.4, k  = 3). Studies on depression, mania, smoking, and alcohol use had a low heterogeneity between the trials. For other mental disorders, only single studies were identified. Only ten studies had a low risk of bias, and 25 studies reported insufficient statistical power., Discussion: App-based interventions may be used to enhance mental health interventions to further reduce symptoms of depression, anxiety, mania, smoking, and alcohol use. However, the effects were small, except for anxiety, and limited due to study quality. Further high-quality research with larger sample sizes is warranted to better understand how app-based interventions can be most effectively combined with established interventions to improve outcomes., Competing Interests: M.H. is an employee of the Institute for Health Trainings Online (GET.ON/HelloBetter), which aims to implement scientific findings related to digital health interventions into routine care. H.B. reports having received consultancy fees, fees for lectures or workshops from chambers of psychotherapists and training institutes for psychotherapists, and license fees for an Internet intervention. D.D.E. has served as a consultant to/on the scientific advisory boards of Sanofi, Novartis, Minddistrict, Lantern, Schoen Kliniken, Ideamed, German health insurance companies (BARMER, Techniker Krankenkasse), and a number of federal chambers for psychotherapy. D.D.E. is stakeholder of the GET.ON Institute/HelloBetter, which aims to implement scientific findings related to digital health interventions into routine care. M.B. is stakeholder of the mentalis GmbH, which aims to implement scientific findings related to digital health interventions into routine care. L.M.F., K.K.W., J.K.K., and P.C. declare no competing interests., (© 2023 The Authors.)

Background: Implementing evidence-based healthcare practices (EBPs) is a complex endeavour and often lags behind research-informed decision processes. Understanding and systematically improving implementation using implementation theory can help bridge the gap between research findings and practice. This study aims to translate, pilot, and validate a German version of the English NoMAD questionnaire (G-NoMAD), an instrument derived from the Normalisation Process Theory, to explore the implementation of EBPs., Methods: Survey data has been collected in four German research projects and subsequently combined into a validation data set. Two versions of the G-NoMAD existed, independently translated from the original English version by two research groups. A measurement invariance analysis was conducted, comparing latent scale structures between groups of respondents to both versions. After determining the baseline model, the questionnaire was tested for different degrees of invariance (configural, metric, scalar, and uniqueness) across samples. A confirmatory factor analysis for three models (a four-factor, a unidimensional, and a hierarchical model) was used to examine the theoretical structure of the G-NoMAD. Finally, psychometric results were discussed in a consensus meeting, and the final instructions, items, and scale format were consented to., Results: A total of 539 health care professionals completed the questionnaire. The results of the measurement invariance analysis showed configural, partial metric, and partial scalar invariance indicating that the questionnaire versions are comparable. Internal consistency ranged from acceptable to good (0.79 ≤ α ≤ 0.85) per subscale. Both the four factor and the hierarchical model achieved a better fit than the unidimensional model, with indices from acceptable (SRMR = 0.08) to good (CFI = 0.97; TLI = 0.96). However, the RMSEA values were only close to acceptable (four-factor model: χ2164 = 1029.84, RMSEA = 0.10; hierarchical model: χ2166 = 1073.43, RMSEA = 0.10)., Conclusions: The G-NoMAD provides a reliable and promising tool to measure the degree of normalisation among individuals involved in implementation activities. Since the fit was similar in the four-factor and the hierarchical model, priority should be given to the practical relevance of the hierarchical model, including a total score and four subscale scores. The findings of this study support the further usage of the G-NoMAD in German implementation settings., Trial Registration: Both the AdAM project (No. NCT03430336, 06/02/2018) and the EU-project ImpleMentAll (No. NCT03652883, 29/08/2018) were registered on ClinicalTrials.gov. The ImplementIT study was registered at the German Clinical Trial Registration (No. DRKS00017078, 18/04/2019). The G-NoMAD validation study was registered at the Open Science Framework (No7u9ab, 17/04/2023)., (© 2023. BioMed Central Ltd.)

Low-threshold and remotely delivered preventive interventions, like telephone coaching, are warranted for farmers who experience multiple risk factors for depression, live in underserved areas, and show low help-seeking behavior. Factors facilitating uptake and actual use of effective remote interventions are important to reduce depression disease burden. This study aimed at identifying factors that potentially can influence acceptance of and satisfaction with a telephone coaching in this occupational group.Semi-structured interviews were based on the 'Unified Theory of Acceptance and Use of Technology', the 'Evaluation', and 'Discrepancy' models for satisfaction. Interviews were conducted with 20 of 66 invited participants of a 6-months telephone coaching during an effectiveness or implementation study. Audio-recorded interviews were transcribed and analyzed (deductive-inductive qualitative content analysis). Independent coding by two persons resulted in good agreement (Κ = 0.80). Participants validated results via questionnaire.Overall, 32 supporting (SF) and 14 hindering factors (HF) for acceptance and satisfaction were identified and organized into five dimensions: Coaching result (SF = 9, HF = 3), coach (SF = 9, HF = 1), organization (SF = 5, HF = 2), the telephone as communication medium (SF = 4, HF = 5) and participant characteristics (SF = 5, HF = 3). Most named SFs were 'Flexible appointment arrangement' (n = 19/95 %) and 'low effort' (n = 17/85 %), while most reported HFs were 'lack of visual cues' (n = 12/60 %) and 'social/professional involvement restricts change process' (n = 10/50 %).The perceived changes initiated by coaching, a low effort through telephone conduct, and the indicated personalization were identified as important influencing factors on acceptance and satisfaction based on interviewees' statements. Both may be further enhanced by offering choice and advice for delivery formats (e.g., video-calls) and training of coaches in farm-related issues., Study Registration: German Clinical Trial Registrations: DRKS00017078 and DRKS00015655., Competing Interests: IT reports to have received fees for lectures/workshops in the e-mental-health context from training institutes and congresses for psychotherapists. She was the scientific project leader for the research project ImpleMentAll (11/2017 -03/2021, funded by the European Commission) at the Institute for health training online (GET.ON) which aimed to investigate the effectiveness of tailored implementation strategies compared to implementation as usual. DDE has served as a consultant to/on the scientific advisory boards of Sanofi, Novartis, Minddistrict, Lantern, Schoen Kliniken, Ideamed and German health insurance companies (BARMER, Techniker Krankenkasse) and a number of federal chambers for psychotherapy. DDE and MB are current or former stakeholders of the GET.ON Institute for health training online, which aims to implement scientific findings related to digital health interventions into routine care. MB is scientific advisor of mentalis GmbH, a provider for digital aftercare. HB reports to have received consultancy fees, fees for lectures or workshops from chambers of psychotherapists and training institutes for psychotherapists and license fees for an Internet-intervention. JF, CB, JT, LB report no conflicts of interest., (© 2023 The Authors.)

Abstract: Initial findings indicate the effectiveness of internet-based interventions for body dysmorphic disorder (BDD). In order to substantiate these findings, a seven-module guided internet-based intervention was created and examined. We report the mixed data of participants with clinical and subclinical BDD of the treatment group (n = 18). We investigated the feasibility, the quality of the program content, the design and usability, and its effects on symptom severity and related psychopathology. Adherence to the intervention was low and dropout rate high (55.6%). The program content, perceived website usability, and visual aesthetic were rated high. Credibility and expectancy were on a medium level. Satisfaction with appearance improved significantly in the intention-to-treat analysis (d = 0.58). In sum, symptom-related outcomes and program evaluation showed a positive trend albeit the study conduction was difficult. Future programs should investigate the role of additional motivation strategies and more flexible support addressing the known treatment barriers., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Mental health self-report and clinician-rating scales with diagnoses defined by sum-score cut-offs are often used for depression screening. This study investigates whether machine learning (ML) can detect major depressive episodes (MDE) based on screening scales with higher accuracy than best-practice clinical sum-score approaches., Methods: Primary data was obtained from two RCTs on the treatment of depression. Ground truth were DSM 5 MDE diagnoses based on structured clinical interviews (SCID) and PHQ-9 self-report, clinician-rated QIDS-16, and HAM-D-17 were predictors. ML models were trained using 10-fold cross-validation. Performance was compared against best-practice sum-score cut-offs. Primary outcome was the Area Under the Curve (AUC) of the Receiver Operating Characteristic curve. DeLong's test with bootstrapping was used to test for differences in AUC. Secondary outcomes were balanced accuracy, precision, recall, F1-score, and number needed to diagnose (NND)., Results: A total of k = 1030 diagnoses (no diagnosis: k = 775; MDE: k = 255) were included. ML models achieved an AUC QIDS-16 = 0.94, AUC HAM-D-17 = 0.88, and AUC PHQ-9 = 0.83 in the testing set. ML AUC was significantly higher than sum-score cut-offs for QIDS-16 and PHQ-9 ( ps ≤ 0.01; HAM&#95;D-17: p = 0.847). Applying optimal prediction thresholds, QIDS-16 classifier achieved clinically relevant improvements (Δbalanced accuracy = 8%, ΔF1-score = 14%, ΔNND = 21%). Differences for PHQ&#95;9 and HAM-D-17 were marginal., Conclusions: ML augmented depression screenings could potentially make a major contribution to improving MDE diagnosis depending on questionnaire (e.g., QIDS-16). Confirmatory studies are needed before ML enhanced screening can be implemented into routine care practice., (© The Author(s) 2023.)

Objective: The mechanisms of change in digital interventions for the prevention of depression are largely unknown. Here, we explored whether five theoretically derived intervening variables (i.e., pain intensity, pain-related disability, pain self-efficacy, quality of life [QoL], and work capacity) were mediating the effectiveness of a digital intervention specifically designed to prevent depression in patients with chronic back pain (CBP)., Method: This study is a secondary analysis of a pragmatic, observer-masked randomized clinical trial conducted at 82 orthopedic clinics in Germany. A total of 295 adults with a diagnosis of CBP and subclinical depressive symptoms were randomized to either the intervention group ( n = 149) or treatment-as-usual ( n = 146). Longitudinal mediation analyses were conducted with structural equation modeling and depression symptom severity as primary outcome (Patient Health Questionnaire-9 [PHQ-9]; 6 months after randomization) on an intention-to-treat basis., Results: Beside the effectiveness of the digital intervention in preventing depression, we found a significant causal mediation effect for QoL as measured with the complete scale of Assessment of Quality of Life (AQoL-6D; axb: -0.234), as well as for the QoL subscales mental health (axb: -0.282) and coping (axb: -0.249). All other potential intervening variables were not significant., Conclusion: Our findings suggest a relevant role of QoL, including active coping, as change mechanism in the prevention of depression. Yet, more research is needed to extend and specify our knowledge on empirically supported processes in digital depression prevention. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Background and Aims: Internet use disorder (IUD), characterized as the inability to control one's internet use, is associated with reduced quality of life and mental health comorbidities such as depression, substance abuse, or anxiety. Evidence-based treatment options are scarce due to the novelty of the diagnosis. Internet- and mobile-based interventions (IMI) may be an effective means to deliver psychological treatment to individuals with IUD as they address affected individuals in their online setting. This study presents a newly developed IMI for IUD disclosing treatment satisfaction and preliminary effects by exemplifying with a case report., Methods: The case of a female participant with IUD, characterized by an excessive use of social media, is analyzed. The case report follows the CARE guidelines and presents qualitative and quantitative outcomes regarding potential symptom reduction measured by the Internet Addiction Test (IAT) and Compulsive Internet Use Scale (CIUS), treatment satisfaction measured by the Client Satisfaction Questionnaire (CSQ) and feasibility by analyzing participant's written feedback during treatment., Results: The case report shows that internet- and mobile-based interventions may be feasible in supporting an individual in reducing symptoms of IUD as well as depressive symptoms, anxiety and procrastination behavior. Treatment satisfaction was reported as good., Discussion and Conclusions: This case report illustrates that IMIs can have the potential to be an easily accessible and possibly effective treatment option for IUD. Case studies on IMIs may provide insights into important mechanisms for symptom change. Further studies are needed to expand our understanding of this diverse disorder to provide adequate treatment., Clinical Trial Registration: https://clinicaltrials.gov/,DRKS00015314., Competing Interests: DE reports to have received consultancy fees or served in the scientific advisory board of Minddistrict, Sanofi, Novartis, Lantern, Schoen Kliniken, and German health insurance companies (BARMER, Techniker Krankenkasse). DE and MB are stakeholders of the Institute for Health Trainings Online (HelloBetter), which aims to implement scientific findings related to digital health interventions into routine care. MB is stakeholder of mentalis a digital mental health company. HB reports to have received consultancy fees and fees for lectures or workshops from chambers of psychotherapists and training institutes for psychotherapists. A-CZ reports fees for lectures or workshops and for expert videos for an internet-based intervention. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Bernstein, Zarski, Pekarek, Schaub, Berking, Baumeister and Ebert.)

Individuals with Panic Disorder (PD) often have impaired insight, which can impede their willingness to seek treatment. Cognitive processes, including metacognitive beliefs, cognitive flexibility, and jumping to conclusions (JTC) may influence the degree of insight. By understanding the relationship between insight and these cognitive factors in PD, we can better identify individuals with such vulnerabilities to improve their insight. The aim of this study is to examine the relationships between metacognition, cognitive flexibility, and JTC with clinical and cognitive insight at pretreatment. We investigate the association among those factors' changes and changes in insight over treatment. Eighty-three patients diagnosed with PD received internet-based cognitive behavior therapy. Analyses revealed that metacognition was related to both clinical and cognitive insight, and cognitive flexibility was related to clinical insight at pre-treatment. Greater changes in metacognition were correlated with greater changes in clinical insight. Also, greater changes in cognitive flexibility were related to greater changes in cognitive insight. The current study extends previous studies suggesting potential relationships among insight, metacognition, and cognitive flexibility in PD. Determining the role of cognitive concepts in relation to insight may lead to new avenues for improving insight and can have implications for engagement and treatment-seeking behaviors.

Background: Student mobility across borders poses challenges to health systems at the university and country levels. International students suffer from stress more than their local peers, however, do not seek help or underutilize existing help offers. Some barriers to help-seeking among international students are insufficient information regarding the health offers, stigma, and language, which might be overcome via culturally adapted internet and mobile-based interventions (IMI)., Method: A randomized controlled feasibility trial with a parallel design assessed the feasibility and potential efficacy of an online mindfulness intervention adapted for international university students. Participants were randomized into either an adapted online mindfulness intervention (StudiCareM-E) (IG, n = 20) or a waitlist control group (WL, n = 20). Participants were assessed at baseline (t0) and eight-week post-randomization (t1). The feasibility of StudiCareM-E was evaluated regarding intervention adherence, client satisfaction, and potential negative effects. The potential efficacy of StudiCareM-E was measured by means of the level of mindfulness, perceived stress, depression, anxiety, presenteeism, and wellbeing. Efficacy outcomes were evaluated with regression models on the intention-to-treat (ITT) sample (n = 40), adjusting for the baseline values., Results: Participants' formative feedback suggested improvements in the content of the IMI. There were no crucial negative effects compared to WL. Assessment dropout was 35% (IG: 50%: WL: 20%), and intervention dropout was 60%. StudiCareM-E yielded significant improvements in mindfulness (β = .34), well-being (β = .37), and anxiety (β = -.42) compared to WL., Conclusion: StudiCareM-E might be used among culturally diverse international student populations to improve their well-being. Future studies might carefully inspect the extent of the adaptation needs of their target group and design their interventions accordingly., Competing Interests: The authors have declared that no competing interests exist.

Background: Existing evidence suggests internet- and mobile-based interventions (IMIs) improve depressive symptoms in college students effectively. However, there is far less knowledge about the potential mechanisms of change of mindfulness-based IMIs, which could contribute to optimizing target groups and interventions. Hence, within this secondary analysis of data from a randomized controlled trial (RCT), potential moderators and mediators of the effectiveness of the IMI StudiCare Mindfulness were investigated., Methods: Moderation and mediation analyses were based on secondary data from a RCT that examined the effectiveness of the 7-module IMI StudiCare Mindfulness in a sample of college students (intervention group: n  = 217; waitlist control group: n  = 127). Assessments were collected before (t0; baseline), 4 weeks after (t1; during intervention), and 8 weeks after (t2; post-intervention) randomization. Longitudinal mediation analyses using structural equation modeling were employed, with depressive symptom severity as the dependent variable. For moderation analyses, bilinear interaction models were calculated with depressive symptom severity and mindfulness at t2 as dependent variables. All data-analyses were performed on an intention-to-treat basis., Results: Mediation analyses showed a significant, full mediation of the intervention effect on depressive symptom severity through mindfulness (indirect effect, a * b  = 0.153, p  < 0.01). Only the number of semesters (interaction: β  = 0.24, p  = 0.035) was found to moderate the intervention's effectiveness on depressive symptom severity at t2, and only baseline mindfulness (interaction: β  = -0.20, p  = 0.047) and baseline self-efficacy (interaction: β  = -0.27, p  = 0.012) were found to be significant moderators of the intervention effect on mindfulness at t2., Conclusion: Our results suggest a mediating role of mindfulness. Moderation analyses demonstrated that the intervention improved depressive symptom severity and mindfulness independent of most examined baseline characteristics. Future confirmatory trials will need to support these findings., Clinical Trial Registration: The trial was registered a priori at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (TRN: DRKS00014774; registration date: 18 May 2018)., Competing Interests: A-MK, HB were involved in the development of StudiCare Mindfulness or its predecessor versions. A-MK has received fees for lectures/workshops from chambers of psychotherapists and health insurance companies. HB reports having received consultancy fees and fees for lectures/workshops from chambers of psychotherapists and training institutes for psychotherapists in the e-mental-health context. DDE reports having received consultancy fees from, and served on the scientific advisory boards of, several companies such as Minddistrict, Lantern, Schoen Kliniken, and German health insurance companies. He is a stakeholder of the Institute for health training online (GETON), which aims to implement scientific findings related to digital health interventions into routine care. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Küchler, Kählke, Bantleon, Terhorst, Ebert and Baumeister.)

Background: Depression is highly prevalent among individuals with chronic back pain. Internet-based interventions can be effective in treating and preventing depression in this patient group, but it is unclear who benefits most from this intervention format., Method: In an analysis of two randomized trials ( N  = 504), we explored ways to predict heterogeneous treatment effects of an Internet-based depression intervention for patients with chronic back pain. Univariate treatment-moderator interactions were explored in a first step. Multilevel model-based recursive partitioning was then applied to develop a decision tree model predicting individualized treatment benefits., Results: The average effect on depressive symptoms was d  = -0.43 (95 % CI: -0.68 to -0.17; 9 weeks; PHQ-9). Using univariate models, only back pain medication intake was detected as an effect moderator, predicting higher effects. More complex interactions were found using recursive partitioning, resulting in a final decision tree with six terminal nodes. The model explained a large amount of variation (bootstrap-bias-corrected R 2  = 45 %), with predicted subgroup-conditional effects ranging from d i  = 0.24 to -1.31. External validation in a pilot trial among patients on sick leave ( N  = 76; R 2  = 33 %) pointed to the transportability of the model., Conclusions: The studied intervention is effective in reducing depressive symptoms, but not among all chronic back pain patients. Predictions of the multivariate tree learning model suggest a pattern in which patients with moderate depression and relatively low pain self-efficacy benefit most, while no benefits arise when patients' self-efficacy is already high. If corroborated in further studies, the developed tree algorithm could serve as a practical decision-making tool., Competing Interests: DDE reports to have received consultancy fees or served in the scientific advisory board from several companies such as Novartis, Sanofi, Lantern, Schön Kliniken, Minddistrict, and German health insurance companies (BARMER, Techniker Krankenkasse). DDE and MH are stakeholders of the Institute for Health Trainings Online (GET.ON/HelloBetter), which aims to implement scientific findings related to digital health interventions into routine care. HB reports to have received consultancy fees, fees for lectures or workshops from chambers of psychotherapists and training institutes for psychotherapists and license fees for an Internet intervention., (© 2023 The Authors.)

Background: This study investigates associations of several dimensions of childhood adversities (CAs) with lifetime mental disorders, 12-month disorder persistence, and impairment among incoming college students., Methods: Data come from the World Mental Health International College Student Initiative (WMH-ICS). Web-based surveys conducted in nine countries ( n = 20 427) assessed lifetime and 12-month mental disorders, 12-month role impairment, and seven types of CAs occurring before the age of 18: parental psychopathology, emotional, physical, and sexual abuse, neglect, bullying victimization, and dating violence. Poisson regressions estimated associations using three dimensions of CA exposure: type, number, and frequency., Results: Overall, 75.8% of students reported exposure to at least one CA. In multivariate regression models, lifetime onset and 12-month mood, anxiety, and substance use disorders were all associated with either the type, number, or frequency of CAs. In contrast, none of these associations was significant when predicting disorder persistence. Of the three CA dimensions examined, only frequency was associated with severe role impairment among students with 12-month disorders. Population-attributable risk simulations suggest that 18.7-57.5% of 12-month disorders and 16.3% of severe role impairment among those with disorders were associated with these CAs., Conclusion: CAs are associated with an elevated risk of onset and impairment among 12-month cases of diverse mental disorders but are not involved in disorder persistence. Future research on the associations of CAs with psychopathology should include fine-grained assessments of CA exposure and attempt to trace out modifiable intervention targets linked to mechanisms of associations with lifetime psychopathology and burden of 12-month mental disorders.

Background: Excessive crying, sleeping, and feeding problems in early childhood are major stressors that can result in parents feeling socially isolated and having low self-efficacy. Affected children are a risk group for being maltreated and developing emotional and behavioral problems. Thus, the development of an innovative and interactive psychoeducational app for parents of children with crying, sleeping, and feeding problems may provide low-threshold access to scientifically based information and reduce negative outcomes in parents and children., Objective: We aimed to investigate whether following the use of a newly developed psychoeducational app, the parents of children with crying, sleeping, or feeding problems experienced less parenting stress; gained more knowledge about crying, sleeping, and feeding problems; and perceived themselves as more self-effective and as better socially supported and whether their children's symptoms decreased more than those of the parents who did not use the app., Methods: Our clinical sample consisted of 136 parents of children (aged 0-24 months) who contacted a cry baby outpatient clinic in Bavaria (Southern Germany) for an initial consultation. Using a randomized controlled design, families were randomly allocated to either an intervention group (IG; 73/136, 53.7%) or a waitlist control group (WCG; 63/136, 46.3%) during the usual waiting time until consultation. The IG was given a psychoeducational app that included evidence-based information via text and videos, a child behavior diary function, a parent chat forum and experience report, tips on relaxation, an emergency plan, and a regional directory of specialized counseling centers. Outcome variables were assessed using validated questionnaires at baseline test and posttest. Both groups were compared at posttest regarding changes in parenting stress (primary outcome) and secondary outcomes, namely knowledge about crying, sleeping, and feeding problems; perceived self-efficacy; perceived social support; and child symptoms., Results: The mean individual study duration was 23.41 (SD 10.42) days. The IG reported significantly lower levels of parenting stress (mean 83.18, SD 19.94) after app use compared with the WCG (mean 87.46, SD 16.67; P=.03; Cohen d=0.23). Furthermore, parents in the IG reported a higher level of knowledge about crying, sleeping, and feeding (mean 62.91, SD 4.30) than those in the WCG (mean 61.15, SD 4.46; P<.001; Cohen d=0.38). No differences at posttest were found between groups in terms of parental efficacy (P=.34; Cohen d=0.05), perceived social support (P=.66; Cohen d=0.04), and child symptoms (P=.35; Cohen d=0.10)., Conclusions: This study provides initial evidence of the efficacy of a psychoeducational app for parents with child crying, sleeping, and feeding problems. By reducing parental stress and increasing knowledge of children's symptoms, the app has the potential to serve as an effective secondary preventive measure. Additional large-scale studies are needed to investigate long-term benefits., Trial Registration: German Clinical Trials Register DRKS00019001; https://drks.de/search/en/trial/DRKS00019001., (©Michaela Augustin, Maria Licata-Dandel, Linda D Breeman, Mathias Harrer, Ayten Bilgin, Dieter Wolke, Volker Mall, Margret Ziegler, David Daniel Ebert, Anna Friedmann. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 10.03.2023.)

The college years can be accompanied by mental distress. Internet- and mobile-based interventions (IMIs) have the potential to improve mental health but adherence is problematic. Psychological guidance might promote adherence but is resource intensive. In this three-armed randomized controlled trial, "guidance on demand" (GoD) and unguided (UG) adherence-promoting versions of the seven-module IMI StudiCare Mindfulness were compared with a waitlist control group and each other. The GoD participants could ask for guidance as needed. A total of 387 students with moderate/low mindfulness were recruited. Follow-up assessments took place after 1 (t1), 2 (t2), and 6 (t3) months. Post-intervention (t2), both versions significantly improved the primary outcome of mindfulness ( d = 0.91-1.06, 95% CI 0.66-1.32) and most other mental health outcomes ( d = 0.25-0.69, 95% CI 0.00-0.94) compared with WL, with effects generally persisting after 6 months. Exploratory comparisons between UG and GoD were mostly non-significant. Adherence was low but significantly higher in GoD (39%) vs. UG (28%) at the 6-month follow-up. Across versions, 15% of participants experienced negative effects, which were mostly mild. Both versions effectively promoted mental health in college students. Overall, GoD was not associated with substantial gains in effectiveness or adherence compared with UG. Future studies should investigate persuasive design to improve adherence.

Background: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary., Objective: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia., Methods: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit., Results: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it., Conclusions: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice., Trial Registration: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883., International Registered Report Identifier (irrid): RR2-10.1186/s13063-020-04686-4., (©Christiaan Vis, Josien Schuurmans, Bruno Aouizerate, Mette Atipei Craggs, Philip Batterham, Leah Bührmann, Alison Calear, Arlinda Cerga Pashoja, Helen Christensen, Els Dozeman, Claus Duedal Pedersen, David Daniel Ebert, Anne Etzelmueller, Naim Fanaj, Tracy L Finch, Denise Hanssen, Ulrich Hegerl, Adriaan Hoogendoorn, Kim Mathiasen, Carl May, Andia Meksi, Sevim Mustafa, Bridianne O'Dea, Caroline Oehler, Jordi Piera-Jiménez, Sebastian Potthoff, Gentiana Qirjako, Tim Rapley, Judith Rosmalen, Ylenia Sacco, Ludovic Samalin, Mette Maria Skjoth, Kristine Tarp, Ingrid Titzler, Erik Van der Eycken, Claire Rosalie van Genugten, Alexis Whitton, Enrico Zanalda, Jan H Smit, Heleen Riper. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 03.02.2023.)

Background: Although non-suicidal self-injury (NSSI) is an issue of major concern to colleges worldwide, we lack detailed information about the epidemiology of NSSI among college students. The objectives of this study were to present the first cross-national data on the prevalence of NSSI and NSSI disorder among first-year college students and its association with mental disorders., Methods: Data come from a survey of the entering class in 24 colleges across nine countries participating in the World Mental Health International College Student (WMH-ICS) initiative assessed in web-based self-report surveys (20 842 first-year students). Using retrospective age-of-onset reports, we investigated time-ordered associations between NSSI and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV) mood (major depressive and bipolar disorder), anxiety (generalized anxiety and panic disorder), and substance use disorders (alcohol and drug use disorder)., Results: NSSI lifetime and 12-month prevalence were 17.7% and 8.4%. A positive screen of 12-month DSM-5 NSSI disorder was 2.3%. Of those with lifetime NSSI, 59.6% met the criteria for at least one mental disorder. Temporally primary lifetime mental disorders predicted subsequent onset of NSSI [median odds ratio (OR) 2.4], but these primary lifetime disorders did not consistently predict 12-month NSSI among respondents with lifetime NSSI. Conversely, even after controlling for pre-existing mental disorders, NSSI consistently predicted later onset of mental disorders (median OR 1.8) as well as 12-month persistence of mental disorders among students with a generalized anxiety disorder (OR 1.6) and bipolar disorder (OR 4.6)., Conclusions: NSSI is common among first-year college students and is a behavioral marker of various common mental disorders.

Introduction: Depression has a significant impact on individuals and society, which is why preventive measures are important. Farmers represent an occupational group exposed to many risk factors for depression. The potential of guided, tailored internet-based interventions and a personalized telephone coaching is evaluated in a German project of the Social Insurance for Agriculture, Forestry and Horticulture (SVLFG). While user outcomes are promising, not much is known about actual routine care use and implementation of the two digital health interventions. This study evaluates the implementation from the perspective of social insurance employees to understand determinants influencing the uptake and implementation of digital interventions to prevent depression in farmers., Methods: The data collection and analysis are based on the Consolidated Framework for Implementation Research (CFIR). Health care workers ( n  = 86) and implementers ( n  = 7) completed online surveys and/or participated in focus groups. The surveys consisted of validated questionnaires used in implementation research, adapted items from the CFIR guide or from other CFIR studies. In addition, we used reporting data to map implementation based on selected CFIR constructs., Results: Within the five CFIR dimensions, many facilitating factors emerged in relation to intervention characteristics (e.g., relative advantage compared to existing services, evidence and quality) and the inner setting of the SVLFG (e.g., tension for change, compatibility with values and existing working processes). In addition, barriers to implementation were identified in relation to the outer setting (patient needs and resources), inner setting (e.g., available resources, access to knowledge and information) and characteristics of individuals (e.g., self-efficacy). With regard to the implementation process, facilitating factors (formal implementation leaders) as well as hindering factors (reflecting and evaluating) were identified., Discussion: The findings shed light on the implementation of two digital prevention services in an agricultural setting. While both offerings seem to be widely accepted by health care workers, the results also point to revealed barriers and contribute to recommendations for further service implementation. For instance, special attention should be given to "patient needs and resources" by raising awareness of mental health issues among the target population as well as barriers regarding the inner setting., Clinical Trial Registration: German Clinical Trial Registration: [DRKS00017078]. Registered on 18.04.2019., Competing Interests: DE has served as a consultant to/on the scientific advisory boards of Sanofi, Novartis, Minddistrict, Lantern, Schoen Kliniken, Ideamed and German health insurance companies (BARMER, Techniker Krankenkasse) and a number of federal chambers for psychotherapy. DE is stakeholder of the GET.ON Institute/HelloBetter, which aims to implement scientific findings related to digital health interventions into routine care. HB has received consultancy fees, fees for lectures/workshops from chambers of psychotherapists and training institutes for psychotherapists in the e-mental-health context and license fees for an internet intervention. MB is scientific advisor of mentalis GmbH and GET.ON Institute/HelloBetter, both providers of digital mental health care products and services. MB is also co-founder and stakeholder of mentalis GmbH. IT reports to have received fees for lectures/workshops in the e-mental-health context from training institutes and congresses for psychotherapists. She was the project lead for the research project ImpleMentAll (funded by the European Commission) at GET.ON, which aimed to investigate the effectiveness of tailored implementation strategies compared to implementation as usual (11/2017-03/2021). JF, JT, LB declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Freund, Ebert, Thielecke, Braun, Baumeister, Berking and Titzler.)

In view of the staggering disease and economic burden of mental disorders, internet and mobile-based interventions (IMIs) targeting mental disorders have often been touted to be cost-effective; however, available evidence is inconclusive and outdated. This review aimed to provide an overview of the cost-effectiveness of IMIs for mental disorders and symptoms. A systematic search was conducted for trial-based economic evaluations published before 10th May 2021. Electronic databases (including MEDLINE, PsycINFO, CENTRAL, PSYNDEX, and NHS Economic Evaluations Database) were searched for randomized controlled trials examining IMIs targeting mental disorders and symptoms and conducting a full health economic evaluation. Methodological quality and risk of bias were assessed. Cost-effectiveness was assumed at or below £30,000 per quality-adjusted life year gained. Of the 4044 studies, 36 economic evaluations were reviewed. Guided IMIs were likely to be cost-effective in depression and anxiety. The quality of most evaluations was good, albeit with some risks of bias. Heterogeneity across studies was high because of factors such as different costing methods, design, comparison groups, and outcomes used. IMIs for anxiety and depression have potential to be cost-effective. However, more research is needed into unguided (preventive) IMIs with active control conditions (e.g., treatment as usual) and longer time horizon across a wider range of disorders.Trial registration: PROSPERO Registration No. CRD42018093808., (© 2022. The Author(s).)

Introduction: Digital health interventions are an effective way to treat depression, but it is still largely unclear how patients' individual symptoms evolve dynamically during such treatments. Data-driven forecasts of depressive symptoms would allow to greatly improve the personalisation of treatments. In current forecasting approaches, models are often trained on an entire population, resulting in a general model that works overall, but does not translate well to each individual in clinically heterogeneous, real-world populations. Model fairness across patient subgroups is also frequently overlooked. Personalised models tailored to the individual patient may therefore be promising., Methods: We investigate different personalisation strategies using transfer learning, subgroup models, as well as subject-dependent standardisation on a newly-collected, longitudinal dataset of depression patients undergoing treatment with a digital intervention ( N = 65 patients recruited). Both passive mobile sensor data as well as ecological momentary assessments were available for modelling. We evaluated the models' ability to predict symptoms of depression (Patient Health Questionnaire-2; PHQ-2) at the end of each day, and to forecast symptoms of the next day., Results: In our experiments, we achieve a best mean-absolute-error (MAE) of 0.801 (25% improvement) for predicting PHQ-2 values at the end of the day with subject-dependent standardisation compared to a non-personalised baseline ( MAE = 1.062 ). For one day ahead-forecasting, we can improve the baseline of 1.539 by 12 % to a MAE of 1.349 using a transfer learning approach with shared common layers. In addition, personalisation leads to fairer models at group-level., Discussion: Our results suggest that personalisation using subject-dependent standardisation and transfer learning can improve predictions and forecasts, respectively, of depressive symptoms in participants of a digital depression intervention. We discuss technical and clinical limitations of this approach, avenues for future investigations, and how personalised machine learning architectures may be implemented to improve existing digital interventions for depression., Competing Interests: EH and DDE are shareholders, and LK and MH are employees of GET.ON Institut für Gesundheitstraings GmbH/HelloBetter, which aims to implement scientific findings related to digital health interventions into routine care. DDE reports to have received consultancy fees or served in the scientific advisory board from several companies such as Novartis, Sanofi, Lantern, Schön Kliniken, Minddistrict, and German health insurance companies (BARMER, Techniker Krankenkasse). BWS is employed by the company audEERING GmbH. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2022 Kathan, Harrer, Küster, Triantafyllopoulos, He, Milling, Gerczuk, Yan, Rajamani, Heber, Grossmann, Ebert and Schuller.)

Background: Internet-based interventions (IBIs) are effective for the prevention and treatment of mental disorders and are valuable additions for improving routine care. However, the uptake of and adherence to IBIs are often limited. To increase the actual use of IBIs, it is important to identify factors for engaging with and adhering to IBIs., Objective: We qualitatively evaluated barriers and facilitators regarding a portfolio of guided IBIs in green professions (farmers, gardeners, and foresters)., Methods: Interview participants were selected from 2 randomized controlled trials for either the prevention of depression (Prevention of Depression in Agriculturists [PROD-A]) or the reduction of pain interference (Preventive Acceptance and Commitment Therapy for Chronic Pain in Agriculturists [PACT-A]) in green professions. The intervention group in PROD-A (N=180) participated in an IBI program, receiving access to 1 of 6 symptom-tailored IBIs. The intervention group in PACT-A (N=44) received access to an IBI for chronic pain. Overall, 41 semistructured qualitative interviews were conducted and transcribed verbatim. Barriers and facilitators were identified via inductive qualitative content analysis, with 2 independent coders reaching almost perfect intercoder reliability (Cohen κ=0.92). A quantitative follow-up survey (30/41, 73%) was conducted to validate the results. Subgroup analyses were performed based on intervention characteristics., Results: We identified 42 barriers and 26 facilitators, which we assigned to 4 superordinate categories related to the intervention (20 barriers; 17 facilitators), work (4 barriers; 1 facilitator), individual (13 barriers; 8 facilitators), and technical (5 barriers; 0 facilitators) aspects. Key barriers (identified by at least 50% of the interviewees) were time-consuming work life (29/40, 73%) and time-consuming private life (23/40, 58%). Similarly, the most frequently identified facilitators included presence of motivation, curiosity, interest and perseverance (30/40, 75%), flexible time management at work (25/40, 63%), and support from family and friends (20/40, 50%). Although agreement with barriers in the quantitative follow-up survey was rather low (mean 24%, SD 11%), agreement with facilitators was substantially higher (mean 80%, SD 13%). Differences in agreement rates were found particularly between intervention completers and noncompleters. Completers agreed significantly more often that perceived IBI success; being motivated, curious, interested, and perseverant; and having a persisting level of psychological strain have been facilitating. Noncompleters agreed more often with experiencing the e-coach contact as insufficient and technical problems as hindering for intervention completion., Conclusions: Based on these results, strategies such as customization of modules for more flexible and adaptive use; video chat options with the e-coach; options to facilitate social support by family, friends, or other participants; or using prompts to facilitate training completion can be derived. These approaches could be evaluated in further quantitative research designs in terms of their potential to enhance intervention use in this occupational group., Trial Registration: German Clinical Trials Register DRKS00014000, https://tinyurl.com/3bukfr48; German Clinical Trials Register DRKS0001461, https://tinyurl.com/ebsn4sns., (©Lina Braun, Johanna Freund, Janika Thielecke, Harald Baumeister, David Daniel Ebert, Ingrid Titzler. Originally published in JMIR Mental Health (https://mental.jmir.org), 09.11.2022.)

Musculoskeletal symptoms are increased in farmers, whereas the prevalence of chronified pain is unknown. Online interventions based on acceptance and commitment therapy (ACT) have shown encouraging results in the general population, representing a promising approach for reducing pain interference in green professions (i.e., farmers, foresters, gardeners). We conducted a pragmatic RCT comparing a guided ACT-based online intervention to enhanced treatment-as-usual in entrepreneurs, contributing spouses, family members and pensioners in green professions with chronic pain (CPG: ≥grade II, ≥6 months). Recruitment was terminated prematurely after 2.5 years at N = 89 (of planned N = 286). Assessments were conducted at 9 weeks (T1), 6 months (T2) and 12 months (T3) post-randomization. The primary outcome was pain interference (T1). The secondary outcomes encompassed pain-, health- and intervention-related variables. No treatment effect for reduction of pain interference was found at T1 (β = -0.16, 95%CI: -0.64-0.32, p = 0.256). Improvements in cognitive fusion, pain acceptance, anxiety, perceived stress and quality of life were found only at T3. Intervention satisfaction as well as therapeutic and technological alliances were moderate, and uptake and adherence were low. Results are restricted by low statistical power due to recruitment issues, high study attrition and low intervention adherence, standing in contrast to previous studies. Further research is warranted regarding the use of ACT-based online interventions for chronic pain in this occupational group. Trial registration: German Clinical Trial Registration: DRKS00014619. Registered: 16 April 2018.

Background: Work stress is highly prevalent and puts employees at risk for adverse health consequences. Web-based stress management interventions (SMIs) promoting occupational self-efficacy might be a feasible approach to aid employees to alleviate this burden and to enable them to improve an unbalanced situation between efforts and rewards at work., Objective: The first aim of this randomized controlled trial was to investigate the efficacy of a web-based SMI for employees perceiving elevated stress levels and an effort-reward imbalance in comparison to a waitlist control (WLC) group. Second, we investigated whether the efficacy of an SMI could be explained by an increase in occupational self-efficacy and whether this personal resource enables employees to change adverse working conditions., Methods: A total of 262 employees reporting effort-reward imbalance scores over 0.715 and elevated stress levels (10-item Perceived Stress Scale [PSS-10] score ≥22) were randomly assigned to either the intervention group (IG; SMI) or the WLC group. The primary outcome was perceived stress measured using the PSS-10. The secondary outcomes included mental and work-related health measures. Four different mediation analyses were conducted with occupational self-efficacy, efforts, and rewards as mediators. After eligibility screening, data were collected web based at baseline (T1), 7 weeks (T2) and 6 months (T3)., Results: Study participation was completed by 80% (105/130, 80.8%) in the IG and 90% (119/132, 90.2%) in the WLC group. Analyses of covariance revealed that stress reduction was significantly higher for the SMI group compared with the WLC group at T2 (d=0.87, 95% CI 0.61-1.12, P<.001) and T3 (d=0.65, 95% CI 0.41-0.90, P<.001). Mediation analyses indicated that occupational self-efficacy mediated the beneficial effect of the SMI on stress directly. Furthermore, the analyses revealed a significant indirect effect of occupational self-efficacy via rewards (b=0.18, t 259 =4.52, P<.001), but not via efforts (b=0.01, t 259 =0.27, P>.05) while efforts still had a negative impact on stress (b=0.46, t 257 =2.32, P<.05)., Conclusions: The SMI was effective in reducing stress and improving occupational self-efficacy in employees despite them experiencing an effort-reward imbalance at work. Results from mediation analyses suggest that fostering personal resources such as occupational self-efficacy contributes to the efficacy of the SMI and enables employees to achieve positive changes regarding the rewarding aspects of the workplace. However, the SMI seemed to neither directly nor indirectly impact efforts, suggesting that person-focused interventions might not be sufficient and need to be complemented by organizational-focused interventions to comprehensively improve mental health in employees facing adverse working conditions., Trial Registration: German Clinical Trials Register DRKS00005990; https://tinyurl.com/23fmzfu3., (©Patricia Nixon, David Daniel Ebert, Leif Boß, Peter Angerer, Nico Dragano, Dirk Lehr. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 20.10.2022.)

Introduction: The efficacy and effectiveness of digital interventions for depression are both well-established. However, precise effect size estimates for mediators transmitting the effects of digital interventions are not available; and integrative insights on the specific mechanisms of change in internet- and mobile-based interventions (IMIs)-as related to key features like delivery type, accompanying support and theoretical foundation-are largely pending., Objective: We will conduct a systematic review and individual participant data meta-analysis (IPD-MA) evaluating the mediators associated with therapeutic change in various IMIs for depression in adults., Methods: We will use three electronic databases (i.e., Embase, Medline/PubMed, PsycINFO) as well as an already established database of IPD to identify relevant published and unpublished studies. We will include (1) randomized controlled trials that examine (2) mediators of (3) guided and unguided (4) IMIs with (5) various theoretical orientations for (6) adults with (7) clinically relevant symptoms of depression (8) compared to an active or passive control condition (9) with depression symptom severity as primary outcome. Study selection, data extraction, as well as quality and risk of bias (RoB) assessment will be done independently by two reviewers. Corresponding authors of eligible primary studies will be invited to share their IPD for this meta-analytic study. In a 1-stage IPD-MA, mediation analyses (e.g., on potential mediators like self-efficacy, emotion regulation or problem solving) will be performed using a multilevel structural equation modeling approach within a random-effects framework. Indirect effects will be estimated, with multiple imputation for missing data; the overall model fit will be evaluated and statistical heterogeneity will be assessed. Furthermore, we will investigate if indirect effects are moderated by different variables on participant- (e.g., age, sex/gender, symptom severity), study- (e.g., quality, studies evaluating the temporal ordering of changes in mediators and outcomes), and intervention-level (e.g., theoretical foundation, delivery type, guidance)., Discussion: This systematic review and IPD-MA will generate comprehensive information on the differential strength of mediators and associated therapeutic processes in digital interventions for depression. The findings might contribute to the empirically-informed advancement of psychotherapeutic interventions, leading to more effective interventions and improved treatment outcomes in digital mental health. Besides, with our novel approach to mediation analyses with IPD-MA, we might also add to a methodological progression of evidence-synthesis in psychotherapy process research., Study Registration With Open Science Framework Osf: https://osf.io/md7pq/., Competing Interests: MD reports to have received fees for lectures and workshops for different psychotherapy training institutes. LS reports to have received personal fees from psychotherapy training institutes, health insurance companies, and clinic providers in the context of e-mental-health outside the submitted work. DE reports to have received consultancy fees or served in the scientific advisory board from several companies such as Novartis, Sanofi, Lantern, Schön Kliniken, Minddistrict, and German health insurance companies BARMER, Techniker Krankenkasse. DE is stakeholder of the Institute for Health Trainings Online GET.ON, which aims to implement scientific findings related to digital health interventions into routine care. HB reports to have received consultancy fees, fees for lectures or workshops from chambers of psychotherapists and training institutes for psychotherapists and license fees for an Internet-intervention. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer KM declared a past collaboration with the authors DE and EK to the handling editor., (Copyright © 2022 Domhardt, Grund, Mayer, Büscher, Ebert, Sander, Karyotaki, Cuijpers and Baumeister.)