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The NoMAD questionnaire is a measurement instrument to assess normalisation as an implementation outcome. The original English version of the questionnaire was developed by Finch and colleagues (2018).The NoMAD has been translated into several languages. This project brings NoMAD data from German health care innovation implementation projects together to derive a common German Normalization Process Theory Measure (G-NoMAD).

Introduction: Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+). Methods and analysis: A two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9 weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups. Ethics and dissemination: This study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17-FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences. Trial registration number: German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018., publishedVersion

Supplemental material, sj-docx-1-jtt-10.1177_1357633X221106027 for Janika Thielecke, Claudia Buntrock, Ingrid Titzler, Lina Braun, Johanna Freund, Matthias Berking, Harald Baumeister and David D. Ebert by Telephone coaching for the prevention of depression in depression in farmers: Results from a pragmatic from a pragmatic randomized controlled trial in Journal of Telemedicine and Telecare

Background: Sleep disturbance symptoms are common in major depressive disorder (MDD) and have been found to hamper the treatment effect of conventional face-to-face psychological treatments such as cognitive behavioral therapy. To increase the dissemination of evidence-based treatment, blended cognitive behavioral therapy (bCBT) consisting of web-based and face-to-face treatment is on the rise for patients with MDD. To date, no study has examined whether sleep disturbance symptoms have an impact on bCBT treatment outcomes and whether it affects bCBT and treatment-as-usual (TAU) equally. Objective: The objectives of this study are to investigate whether baseline sleep disturbance symptoms have an impact on treatment outcomes independent of treatment modality and whether sleep disturbance symptoms impact bCBT and TAU in routine care equally. Methods: The study was based on data from the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment Versus Treatment-as-Usual) study, a 2-arm, multisite, parallel randomized controlled, noninferiority trial. A total of 943 outpatients with MDD were randomized to either bCBT (476/943, 50.5%) or TAU consisting of routine clinical MDD treatment (467/943, 49.5%). The primary outcome of this study was the change in depression symptom severity at the 12-month follow-up. The secondary outcomes were the change in depression symptom severity at the 3- and 6-month follow-up and MDD diagnoses at the 12-month follow-up, assessed using the Patient Health Questionnaire-9 and Mini-International Neuropsychiatric Interview, respectively. Mixed effects models were used to examine the association of sleep disturbance symptoms with treatment outcome and treatment modality over time. Results: Of the 943 patients recruited for the study, 558 (59.2%) completed the 12-month follow-up assessment. In the total sample, baseline sleep disturbance symptoms did not significantly affect change in depressive symptom severity at the 12-month follow-up (β=.16, 95% CI –0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (β=.49, 95% CI 0.22-0.76) but not for TAU (β=–.23, 95% CI −0.50 to 0.05) at the 12-month follow-up, even when adjusting for baseline depression symptom severity. The same result was seen for the effect of sleep disturbance symptoms on the presence of depression measured with Mini-International Neuropsychiatric Interview at the 12-month follow-up. However, for both treatment formats, baseline sleep disturbance symptoms were not associated with depression symptom severity at either the 3- (β=.06, 95% CI −0.11 to 0.23) or 6-month (β=.09, 95% CI −0.10 to 0.28) follow-up. Conclusions: Baseline sleep disturbance symptoms may have a negative impact on long-term treatment outcomes in bCBT for MDD. This effect was not observed for TAU. These findings suggest that special attention to sleep disturbance symptoms might be warranted when MDD is treated with bCBT. Future studies should investigate the effect of implementing modules specifically targeting sleep disturbance symptoms in bCBT for MDD to improve long-term prognosis.

Background: Sleep disturbance symptoms are common in major depressive disorder (MDD) and have been found to hamper the treatment effect of conventional face-to-face psychological treatments such as cognitive behavioral therapy. To increase the dissemination of evidence-based treatment, blended cognitive behavioral therapy (bCBT) consisting of web-based and face-to-face treatment is on the rise for patients with MDD. To date, no study has examined whether sleep disturbance symptoms have an impact on bCBT treatment outcomes and whether it affects bCBT and treatment-as-usual (TAU) equally. Objective: The objectives of this study are to investigate whether baseline sleep disturbance symptoms have an impact on treatment outcomes independent of treatment modality and whether sleep disturbance symptoms impact bCBT and TAU in routine care equally. Methods: The study was based on data from the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment Versus Treatment-as-Usual) study, a 2-arm, multisite, parallel randomized controlled, noninferiority trial. A total of 943 outpatients with MDD were randomized to either bCBT (476/943, 50.5%) or TAU consisting of routine clinical MDD treatment (467/943, 49.5%). The primary outcome of this study was the change in depression symptom severity at the 12-month follow-up. The secondary outcomes were the change in depression symptom severity at the 3- and 6-month follow-up and MDD diagnoses at the 12-month follow-up, assessed using the Patient Health Questionnaire-9 and Mini-International Neuropsychiatric Interview, respectively. Mixed effects models were used to examine the association of sleep disturbance symptoms with treatment outcome and treatment modality over time. Results: Of the 943 patients recruited for the study, 558 (59.2%) completed the 12-month follow-up assessment. In the total sample, baseline sleep disturbance symptoms did not significantly affect change in depressive symptom severity at the 12-month follow-up (β=.16, 95% CI –0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (β=.49, 95% CI 0.22-0.76) but not for TAU (β=–.23, 95% CI −0.50 to 0.05) at the 12-month follow-up, even when adjusting for baseline depression symptom severity. The same result was seen for the effect of sleep disturbance symptoms on the presence of depression measured with Mini-International Neuropsychiatric Interview at the 12-month follow-up. However, for both treatment formats, baseline sleep disturbance symptoms were not associated with depression symptom severity at either the 3- (β=.06, 95% CI −0.11 to 0.23) or 6-month (β=.09, 95% CI −0.10 to 0.28) follow-up. Conclusions: Baseline sleep disturbance symptoms may have a negative impact on long-term treatment outcomes in bCBT for MDD. This effect was not observed for TAU. These findings suggest that special attention to sleep disturbance symptoms might be warranted when MDD is treated with bCBT. Future studies should investigate the effect of implementing modules specifically targeting sleep disturbance symptoms in bCBT for MDD to improve long-term prognosis.

Introduction: Internet- and mobile-based interventions (IMIs) and their integration into routine psychotherapy (i.e., blended therapy) can offer a means of complementing psychotherapy in a flexible and resource optimized way. Objective: The present study will evaluate the non-inferiority, cost-effectiveness, and safety of two versions of integrated blended psychotherapy for depression and anxiety compared to standard cognitive behavioral therapy (CBT). Methods: A three-armed multicenter cluster-randomized controlled non-inferiority trial will be conducted comparing two implementations of blended psychotherapy (PSYCHOnlineTHERAPYfix/flex) compared to CBT. Seventy-five outpatient psychotherapists with a CBT-license will be randomized in a 1:1:1 ratio. Each of them is asked to include 12 patients on average with depressive or anxiety disorders resulting in a total sample size of N = 900. All patients receive up to a maximum of 16 psychotherapy sessions, either as routine CBT or alternating with Online self-help sessions (fix: 8/8; flex: 0–16). Assessments will be conducted at patient study inclusion (pre-treatment) and 6, 12, 18, and 24 weeks and 12 months post-inclusion. The primary outcome is depression and anxiety severity at 18 weeks post-inclusion (post-treatment) using the Patient Health Questionnaire Anxiety and Depression Scale. Secondary outcomes are depression and anxiety remission, treatment response, health-related quality of life, patient satisfaction, working alliance, psychotherapy adherence, and patient safety. Additionally, several potential moderators and mediators including patient characteristics and attitudes toward the interventions will be examined, complemented by ecological day-to-day digital behavior variables via passive smartphone sensing as part of an integrated smart-sensing sub-study. Data-analysis will be performed on an intention-to-treat basis with additional per-protocol analyses. In addition, cost-effectiveness and cost-utility analyses will be conducted from a societal and a public health care perspective. Additionally, qualitative interviews on acceptance, feasibility, and optimization potential will be conducted and analyzed. Discussion: PSYCHOnlineTHERAPY will provide evidence on blended psychotherapy in one of the largest ever conducted psychotherapy trials. If shown to be non-inferior and cost-effective, PSYCHOnlineTHERAPY has the potential to innovate psychotherapy in the near future by extending the ways of conducting psychotherapy. The rigorous health care services approach will facilitate a timely implementation of blended psychotherapy into standard care. Trial Registration: The trial is registered in the German Clinical Trials Register (DRKS00023973; date of registration: December 28th 2020)., publishedVersion

Additional file 1. Standards for Reporting Implementation Studies: the StaRI checklist for completion

Additional file 3. Description of the personalised tele-based coaching (IVPNetworks)

Additional file 2. Description of the GET.ON online health trainings

Introduction Blended therapies (BT) combine face-to-face (f2f) sessions with internet- and mobile-based interventions (IMIs). However, the use of blended interventions in routine care is still rare and depends on the acceptance of key health care professionals such as the therapists. Little is yet known about the therapists' perspective on and experiences with blended approaches. The aim of this pilot study was to identify barriers and facilitators, as perceived by psychotherapists, for implementing a blended therapy for depression. Methods Semi-structured expert interviews were conducted with five therapists, who were part of the German study arm of the FP7-project E-Compared (www.e-compared.eu). All patients (N = 173) were treated in the context of a registered RCT (DRKS00006866) in which the clinical and cost-effectiveness of BT for depression, consisting of ten internet- and mobile-based cognitive behavioral therapy modules and six f2f sessions, was compared to the treatment usually provided by general practitioners. To identify barriers and facilitators an interview guide based on the theoretical domains framework (TDF) was developed. The interviews were audio-recorded, transcribed verbatim and analyzed using a qualitative content analysis by two independent coders. Results The results revealed 29 barriers and 33 facilitators, which are hindering or enabling factors on the levels of ‘implementation in the health care system’, ‘therapy’, ‘therapists’ and ‘patients’. Key barriers stated by all therapists were ‘Limited customizability and autonomy of decisions concerning blending the therapy’ (number of statements, k = 44); ‘Disease-related contraindications for BT’ (k = 25); ‘Negative affect was caused by burden through technical problems’ (k = 18); ‘Limited number of f2f sessions hindered the therapy process’; and ‘Establishment of therapeutic alliance was burdened by technical issues’ (each k = 15). Key facilitators stated by all therapists were: ‘Patients’ interest, willingness and motivation to participate’ (k = 22); ‘Patients' access to online content between f2f sessions and after therapy end’ (k = 20); ‘Preset structure of IMI-part guided the treatment course of BT’ (k = 18); and ‘Effective help with BT in a short time frame’ (k = 15), as well as ‘Reduction of the treatment gap’ (k = 13). Discussion Therapists supported the implementation of BT for depression. Results indicated the consideration of a wide range of determinants: among others, the possibility of individualizing the treatment; the autonomy of decision making in respect to the ratio and number of online and f2f sessions; the necessity of providing training; the need to develop a concept of embedding BT in the health care system and funding the additional effort; and the use of sophisticated technical solutions., Highlights • Blended therapies (BT) combine face to face sessions with internet- and mobile-based interventions as new treatment format • Therapists advocated the implementation of BT for depression in routine care • Therapists saw the possibility of combining the best of both in their daily work • Results indicated the consideration of a wide range of hindering and facilitating determinants regarding the implementation • BT as a 13-weeks blended approach may help to reduce the treatment gap