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Background Irritable bowel syndrome (IBS) is a debilitating and costly disorder. Cognitive behavior therapy (CBT) is effective in the treatment of IBS, both when delivered over the internet and in face-to-face settings. CBT consists of different components and little is known about their relative importance. We have in an earlier study showed that inclusion of exposure in the CBT for IBS makes it even more effective. In the present study we wanted to evaluate the economic effects for society of inclusion vs exclusion of exposure in an internet delivered CBT for IBS. Methods We used data from a previous study with 309 participants with IBS. Participants were randomized to internet delivered CBT with (ICBT) or without exposure (ICBT-WE). We compared direct and indirect costs at baseline, after treatment, and 6 months after treatment (primary endpoint; 6MFU). Data was also collected on symptom severity and time spent by therapists and participants. The relative Incremental Cost Effectiveness Ratio (ICER) was calculated for the two treatment conditions and the return on investment (ROI). Results Results showed that ICBT cost $213.5 (20%) more than ICBT-WE per participant. However, ICBT was associated with larger reductions regarding both costs and symptoms than ICBT-WE at 6MFU. The ICER was − 301.69, meaning that for every point improvement on the Gastrointestinal Symptom Rating Scale—IBS version in ICBT, societal costs would be reduced with approximately $300. At a willingness to pay for a case of clinically significant improvement in IBS symptoms of $0, there was an 84% probability of cost-effectiveness. ROI analysis showed that for every $1 invested in ICBT rather than ICBT-WE, the return would be $5.64 six months after treatment. Analyses of post-treatment data showed a similar pattern although cost-savings were smaller. Conclusions Including exposure in Cognitive Behavior Treatment for IBS is more cost-effective from a societal perspective than not including it, even though it may demand more therapist and patient time in the short term. Trial registration This study is reported in accordance with the CONSORT statement for non-pharmacological trials [1]. Clinicaltrials.gov registration ID: NCT01529567 (14/02/2013).

Background:Cognitive behavioural therapy (CBT) is an effective treatment for panic disorder with agoraphobia (PDA). However, implementation of some of the procedures involved, particularly in vivo exposure, can be time consuming and taxing for routine health care services. CBT with exposure taking place in virtual reality (VR-CBT) is a more time-efficient option and has shown promising results in the treatment of PDA. However, VR-CBT requires expensive equipment and appropriate virtual environments, which historically has been costly and cumbersome to produce. Thus, access to VR-CBT has been sparse in regular care environments.Aims:The aim of this study was to investigate whether VR-CBT using filmed virtual environments produced with a low-cost 360-degree film camera can be a feasible and acceptable treatment for PDA when implemented in a primary care context.Method:This was an open feasibility trial with a within-group design, with assessments conducted at pre-test, post-test, and 6-month follow-up. Participants (n = 12) received a 10–12 week treatment programme of VR-CBT and PDA-related symptoms were assessed by the primary outcome measure The Mobility Inventory for Agoraphobia (MIA) and the Panic-Disorder Severity Scale-Self Rated (PDSS-SR).Results:The results showed that treatment satisfaction was high and participants were significantly improved on PDA-related measures at post-treatment and at 6-month follow-up with large effect sizes (Cohen’s d range = 1.46–2.82). All 12 participants completed the treatment.Conclusions:These findings suggest that VR-CBT with 360-degree video virtual environments delivered to primary care patients with PDA is feasible, acceptable, and potentially efficacious.

Dear Editor, Thank you for giving us the opportunity to respond to this letter concerning our recent meta-analysis of randomized controlled trials of cognitive behavior therapy (CBT) for health anx...

Cognitive behavioural therapy (CBT) can effectively treat common mental disorders (CMDs), but access to treatment is insufficient. Guided self-help (GSH) CBT has shown effects comparable to face-to-face CBT and may be a resource-efficient treatment alternative. However, not all patients respond to GSH. Learning more about predictors of outcome may increase knowledge regarding which patients respond to GSH. The aim of this study was to investigate predictors of outcome for GSH CBT for patients with CMDs in primary care. Consecutive patients (N = 396) with a principal disorder of depression, anxiety, insomnia or stress-related disorders were included. All patients received GSH CBT. Outcomes were remission status, reliable change and post-treatment depression ratings. Predictors investigated were clinical, demographic and therapy-related variables. Analyses were conducted using logistic and linear regression. Higher educational level predicted remission, higher quality of life ratings predicted remission and decreased depression, and higher age at onset predicted reliable change. Therapy-related variables, i.e. patient adherence to treatment and patients' and clinicians' estimation of treatment response, were all related to outcome. More large-scale studies are needed, but the present study points at the importance of therapy-related variables such as monitoring and supporting treatment adherence for an increased chance of remission.

IMPORTANCE: Atopic dermatitis is a common and debilitating skin condition characterized by intense itching and chronic inflammation. Research on behavioral treatments with high accessibility is needed. OBJECTIVE: To investigate the efficacy of a highly scalable internet-delivered cognitive behavior therapy (CBT) for adults with atopic dermatitis. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial from a medical university in Stockholm, Sweden, included 102 adults with atopic dermatitis, recruited from across Sweden, who received 12 weeks of internet-delivered CBT (March 29, 2017, to February 16, 2018). The first participant provided screening data on November 27, 2016, and the last 1-year follow-up assessment was conducted on June 28, 2019. INTERVENTIONS: Participants were randomized in a 1:1 ratio to 12 weeks of therapist-guided internet-delivered CBT (n = 51) or a control condition (n = 51) that gave instructions about standard care. MAIN OUTCOMES AND MEASURES: The primary outcome was the between-group difference in mean reduction of atopic dermatitis symptoms as measured by the Patient-Oriented Eczema Measure and modeled intention to treat during the 12-week treatment period. RESULTS: A total of 102 participants (mean [SD] age, 37 [11] years; 83 [81%] female) were recruited and randomized. The primary analysis indicated that participants receiving internet-delivered CBT, relative to the controls, had a significantly larger mean weekly reduction in symptoms of atopic dermatitis as measured with the Patient-Oriented Eczema Measure (B = 0.32; 95% CI, 0.14-0.49; P

Objectives: Exposure-based cognitive behavioral therapy via internet (Internet-CBT) has been shown to reduce symptoms and increase quality of life for children with functional abdominal pain disorders (FAPDs), but the mechanisms of change are unknown. The objective was to examine whether a change in symptom-specific fear and avoidance, i.e., gastrointestinal-specific anxiety (GI-anxiety) and gastrointestinal-specific avoidance (GI avoidance), mediated changes in parent-reported abdominal symptoms for children receiving Internet-CBT compared with children receiving treatment as usual. A further aim was to assess if baseline levels of the proposed mediators moderated the mediation. Methods: Weekly assessments of child-reported mediators and parent-reported outcome from 90 children aged 8-12 who were included in a randomized controlled trial were used in univariate and multivariate growth models to test the direct effect of treatment on outcome and the indirect effects via mediators and moderated mediation. Results: Treatment condition significantly predicted the slope of the mediators (a-path), in favor of Internet-CBT, and mediators were correlated with the outcome (b-path). The indirect effects of the mediators on the outcome (cross-product of the a and b-paths) were significantly different from zero for both GI-avoidance, ab = 1.43, 95% CI [0.42, 3.23]; and GI-anxiety ab = 1.58, 95%CI [0.43, 3.62]. Baseline levels of the proposed mediators moderated the size of the mediation. Conclusions: GI-anxiety and GI-avoidance were mediators of change in Internet-CBT and high levels of the mediators at baseline were associated with larger mediated effects. Healthcare professionals should be aware of, and inform families about, the potential benefits of reducing symptom-specific fear and avoidance. Funding Agencies|Jane and Dan Olsson Foundation [4-1559/2013]; Swedish Research CouncilSwedish Research Council [521-2013-2846]; Kempe-Carlgrenska Foundation; Ruth and Richard Julin Foundation [2012Juli0048]; Majblomman Foundation; Ishizu Matsumurais Donation; Bengt Ihre Foundation [SLS-331861]; Bengt Ihre research fellowship in Gastroenterology; Swedish Society of Medicine [SLS331681, SLS-410501]; Swedish Research Council for Health, Working life, and WelfareSwedish Research CouncilSwedish Research Council for Health Working Life & Welfare (Forte) [2014-4052]; Centre for Psychiatry Research; Stockholm County CouncilStockholm County Council [20130129, 20150414)]; Karolinska InstitutetKarolinska Institutet [20130129, 20150414]

Though therapist-guided Internet-based cognitive behavior therapy (ICBT) appears to be efficacious for depression, social anxiety disorder, and panic disorder, relatively little is known about real-world settings and predictors of treatment effects derived from cognitive-behavioral theory. We examined treatment effectiveness and predictors of improvement in a prospective cohort study where patients took part in 10 weeks of ICBT for depression (n = 114), social anxiety disorder (n = 150), or panic disorder (n = 106) at a teaching clinic. Patients self-reported symptoms before, during, and after treatment. Effect sizes were large for improvement in the primary symptom domain of each treatment group: depression (d = 1.48), social anxiety disorder (d = 1.01), and panic disorder (d = 1.15). In ICBT for depression, having no previous experience of psychological treatment (r = 0.21), and more frequent baseline negative automatic thoughts (r = 0.20) predicted larger improvement. In ICBT for panic disorder, having more baseline safety behaviors (r = 0.25) predicted larger improvement. Predictors remained significant when baseline symptoms were included in the statistical models. We conclude that ICBT can be effective in a real-world teaching clinic, and that patients with greater deficits at baseline benefit the most.

Importance Health anxiety is a common and often chronic mental health problem associated with distress, substantial costs, and frequent attendance throughout the health care system. Face-to-face cognitive behavior therapy (CBT) is the criterion standard treatment, but access is limited. Objective To test the hypothesis that internet-delivered CBT, which requires relatively little resources, is noninferior to face-to-face CBT in the treatment of health anxiety. Design, Setting, and Participants This randomized noninferiority clinical trial with health economic analysis was based at a primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care. Recruitment began in December 10, 2014, and the last treatment ended on July 23, 2017. Follow-up data were collected up to 12 months after treatment. Analysis began October 2017 and ended March 2020. Interventions Patients were randomized (1:1) to 12 weeks of internet-delivered CBT or to individual face-to-face CBT. Main Outcomes and Measures Change in health anxiety symptoms from baseline to week 12. Analyses were conducted from intention-to-treat and per-protocol (completers only) perspectives, using the noninferiority margin of 2.25 points on the Health Anxiety Inventory, which has a theoretical range of 0 to 54. Results Overall, 204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period. Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50%) were randomized to face-to-face CBT. The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohend = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohend = 0.00; upper limit: 0.25). The between-group effect was not moderated by initial symptom level, recruitment path, or patient treatment preference. Therapists spent 10.0 minutes per patient per week in the online treatment vs 45.6 minutes for face-to-face CBT. The net societal cost was lower in the online treatment (treatment period point difference: $3854). There was no significant group difference in the number of adverse events, and no serious adverse event was reported. Conclusions and Relevance In this trial, internet-delivered CBT appeared to be noninferior to face-to-face CBT for health anxiety, while incurring lower net societal costs. The online treatment format has potential to increase access to evidence-based treatment for health anxiety. Trial Registration ClinicalTrials.gov Identifier:NCT02314065

Depression is common in primary care, and most patients prefer psychological treatment over pharmacotherapy. Cognitive behaviour therapy (CBT) is an effective treatment, but there are gaps in current knowledge about CBT in the primary care context, especially with regard to long-term effects and the efficacy of specific delivery formats. This is an obstacle to the integration of primary care and specialist psychiatry. We conducted a systematic review and meta-analysis of randomised controlled trials of CBT for primary care patients with depression to investigate the effect of CBT for patients with depression in primary care. A total of 34 studies, with 2543 patients in CBT and 2815 patients in control conditions, were included. CBT was more effective than the control conditions [g = 0.22 (95% confidence interval (CI) 0.15–0.30)], and the effect was sustained at follow-up [g = 0.17 (95% CI 0.10–0.24)]. CBT also led to a higher response rate [odds ratio (OR) = 2.47 (95% CI 1.60–3.80)] and remission rate [OR = 1.56 (95% CI 1.15–2.14)] than the control conditions. Heterogeneity was moderate. The controlled effect of CBT was significant regardless of whether patients met diagnostic criteria for depression, scored above a validated cut-off for depression, or merely had depressive symptoms. CBT also had a controlled effect regardless of whether the treatment was delivered as individual therapy, group therapy or therapist-guided self-help. We conclude that CBT appears to be effective for patients with depression in primary care, and recommend that patients with mild to moderate depression be offered CBT in primary care.

Fibromyalgia (FM) is a prevalent and debilitating chronic pain disorder associated with a substantial economic burden. Although there are several studies investigating the effectiveness of psychological treatments such as cognitive-behavioral therapy for FM, studies on cost-effectiveness are scarce. The aim of the present study was to investigate the cost-effectiveness of Internet-delivered exposure therapy (iExp) for FM. We used health economic data from a recently conducted randomized, controlled trial, where 140 participants were randomized to either iExp or a waitlist control (WLC) condition. Economic data were collected at pre-treatment, post-treatment, and at the 1-year follow-up. Treatment effectiveness in relation to costs were analyzed using both a societal perspective (including all direct and indirect costs) and a health care unit perspective (including only the direct treatment costs). Bootstrapped net benefit regression analyses were also conducted, comparing the difference in costs and effects between iExp and WLC, within different willingness-to-pay scenarios. Results showed that the incremental cost-effectiveness ratio was –$15,295, indicating that iExp was highly cost-effective as each successfully treated case (treatment responder) was associated with a substantial net reduction in costs. The robustness of the results was tested in 2 different sensitivity analyses, where iExp remained cost-effective, even in a willingness-to-pay-scenario of $0. We conclude that iExp is a cost-effective treatment that generates large societal cost savings. Perspective Health-economic evaluations of psychological interventions for FM are scarce. This study is a cost-effectiveness analysis of Internet-delivered exposure therapy for patients with FM. Results showed that iExp was highly cost-effective compared with no treatment, where each successfully treated case generated a substantial societal cost saving.

BackgroundExcessive worry is a common phenomenon. Our research group has previously developed an online intervention for excessive worry based on operant principles of extinction (IbET; internet-based extinction therapy) and tested it against a waiting-list. The aim of this study was to evaluate IbET against an active control comparator (CTRL).MethodsA 10-week parallel participant blind randomised controlled trial with health-economical evaluation and mediation analyses. Participants (N = 311) were randomised (ratio 4.5:4.5:1) to IbET, to CTRL (an internet-based stress-management training program) or to waiting-list. The nation-wide trial included self-referred adults with excessive worry. The primary outcome was change in worry assessed with the Penn State Worry Questionnaire from baseline to 10 weeks.ResultsIbET had greater reductions in worry compared to CTRL [−3.6 point difference, (95% CI −2.4 to −4.9)] and also a significantly larger degree of treatment responders [63% v. 51%; risk ratio = 1.24 (95% CI 1.01–1.53)]. Both IbET and CTRL made large reductions in worry compared to waiting-list and effects were sustained up to 1 year. Treatment credibility, therapist attention, compliance and working alliance were equal between IbET and CTRL. Data attrition was 4% at the primary endpoint. The effects of IbET were mediated by the hypothesized causal mechanism (reduced thought suppression) but not by competing mediators. Health-economical evaluation indicated that IbET had a 99% chance of being cost-effective compared to CTRL given societal willingness to pay of 1000€.ConclusionsIbET is more effective than active comparator to treat excessive worry. Replication and extensions to real-world setting are warranted.

Emotion regulation group therapy (ERGT) is a novel treatment specifically targeting deliberate non-suicidal self-harm (DSH) in individuals with borderline personality disorder (BPD). Identifying robust predictors of positive response to ERGT could aid clinicians in treatment selection; however, to date, only one such study has been conducted. Thus, we aimed to replicate previously identified predictors of treatment response to ERGT by investigating demographic, clinical, and diagnostic predictors in 95 women with BPD or subclinical BPD who had participated in an open-trial evaluation of ERGT. Outcomes evaluated were frequency of DSH and emotion dysregulation. Assessments were conducted at pretreatment, post-treatment, and 6-month follow-up. Multilevel mixed linear models and multilevel negative binomial generalized estimated equations were used to identify significant interactions between the predictors and outcomes. We found that greater pretreatment DSH frequency was associated with greater improvements in DSH during treatment (b = 0.998, SE = 0.00, p = 0.03) and follow-up (b = 0.997, SE = 0.00, p < 0.01) and that greater BPD severity was associated with greater improvements in DSH during treatment (b = 0.84, SE = 0.06, p = 0.02) and in emotion dysregulation at follow-up (b = −3.05, SE = 1.47, p = 0.04). Co-occurring disorders were associated with poorer treatment response during follow-up. Results were generally consistent with a previous study of the predictors of response to ERGT. The findings provide further support for the utility of this treatment across a range of BPD patients, including patients with severe DSH and BPD. (Less)

BackgroundBoth internet-based cognitive–behavioural therapy (ICBT) and physical exercise are alternatives to treatment as usual (TAU) in managing mild to moderate depression in primary care.AimsTo determine the cost-effectiveness of ICBT and physical exercise compared with TAU in primary care.MethodEconomic evaluation of a randomised controlled trial (N = 945) in Sweden. Costs were estimated by a service use questionnaire and used together with the effects on quality-adjusted life-years (QALYs). The primary 3-month healthcare provider perspective in primary care was complemented by a 1-year societal perspective.ResultsThe primary analysis showed that incremental cost per QALY gain was €8817 for ICBT and €14 571 for physical exercise compared with TAU. At the established willingness-to-pay threshold of €21 536 (£20 000) per QALY, the probability of ICBT being cost-effective is 90%, and for physical exercise is 76%, compared with TAU.ConclusionsFrom a primary care perspective, both ICBT and physical exercise for depression are likely to be cost-effective compared with TAU.Declaration of interestNone.

Irritable bowel syndrome (IBS) is common in adolescents with a pronounced negative impact on quality of life. A pattern of avoidance behavior is commonly seen in the IBS population, which is associated with more gastrointestinal (GI) symptoms. Exposure-based cognitive behavior therapy (CBT) targets the avoidance behavior to reduce symptoms, but it is unknown whether reduced avoidance is a mediator of symptom improvement in adolescent IBS. Stress has been suggested to play a key role in worsening GI symptoms and is also a potential mediator of the treatment effect in IBS. This study was based on data from a randomized controlled trial (N = 101) that evaluated exposure-based internet-delivered CBT (Internet-CBT) compared with a wait-list for adolescents with IBS. We investigated whether avoidance behavior and perceived stress mediated the improvement in global GI symptoms due to treatment. We found that a change in avoidance behavior, but not perceived stress, mediated the effect of exposure-based Internet-CBT on GI symptoms. The decrease in avoidance behavior explained a large portion (67%) of the total treatment effect. Moreover, a unidirectional relationship over time was observed between avoidance behavior and GI symptoms. Our conclusion is that exposure-based CBT in adolescent IBS reduces avoidance and, consequently, reduces GI symptoms.

Fibromyalgia (FM) is a common and disabling chronic pain disorder, for which existing pharmacological and psychological treatments have yet yielded insufficient effects. Previous literature has shown that exposure therapy may be an effective treatment for chronic pain. This study constitutes the first randomized controlled trial evaluating exposure therapy for FM.A total of 140 participants with diagnosed FM were randomized to a 10-week Internet-delivered exposure treatment (iExp; n=70) or a waitlist control condition (WLC; n=70). Primary outcome measure were FM symptoms and impact, and secondary outcome measures were fatigue, disability, quality of life, pain-related distress and avoidance behaviors, insomnia, depression, and anxiety.Data retention was high (100% data completion at posttreatment for primary outcome, 96% at 6-month follow-up and 94% at 12-month follow-up). Results showed that participants in the iExp group made large and superior improvements compared with WLC on FM symptoms and impact (B, -1.93; z, -10.14; P0.001, between-group Cohen d=0.90), as well as all secondary outcomes (between-group Cohen d ranging from 0.44 to 1.38) with sustained results.We conclude that iExp seems to be an efficacious treatment for FM compared with no treatment, and the results also highlight the potential increase of accessibility by using the Internet format to deliver psychological treatments for these patients. Future trials with active control conditions are warranted.

Sick leave due to common mental disorders (CMDs) increase rapidly and present a major societal challenge. The overall effect of psychological interventions to reduce sick leave and symptoms has not been sufficiently investigated and there is a need for a systematic review and meta-analysis of the field. The aim of the present meta-analysis was to calculate the effect size of psychological interventions for CMDs on sick leave and psychiatric symptoms based on all published randomized controlled trials. Methodological quality, the risk of bias and publication bias were also assessed. The literature searches gave 2240 hits and 45 studies were included. The psychological interventions were more effective than care as usual on both reduced sick leave (g = 0.15) and symptoms (g = 0.21). There was no significant difference in effect between work focused interventions, problem-solving therapy, cognitive behavioural therapy or collaborative care. We conclude that psychological interventions are more effective than care as usual to reduce sick leave and symptoms but the effect sizes are small. More research is needed on psychological interventions that evaluate effects on sick leave. Consensual measures of sick leave should be established and quality of psychotherapy for patients on sick leave should be improved.

Objectives Common mental disorders (CMDs) cause great individual suffering and long-term sick leave. Cognitive–behavioural therapy (CBT) effectively treats CMDs, but sick leave is not reduced to the same extent as psychiatric symptoms. Research results regarding return-to-work interventions (RTW-Is) and their effect on sick leave are inconclusive. The aim of this study was to evaluate CBT, a RTW-I and combined CBT and RTW-I (COMBO) for primary care patients on sick leave due to CMDs. Methods Patients with CMDs (n=211) were randomised to CBT (n=64), RTW-I (n=67) or COMBO (n=80). Sick-leave registry data after 1 year and blinded Clinician’s Severity Rating (CSR) of symptoms post-treatment and at follow-ups after 6 and 12 months were primary outcomes. Results There was no significant difference between treatments in days on sick leave 1 year after treatment start (mean difference in sick-leave days range=9–27). CBT led to larger reduction of symptoms post-treatment (CSR; Cohen’s d=0.4 (95% CI 0.1 to 0.8)) than RTW-I, whereas COMBO did not differ from CBT or RTW-I. At follow-up, after 1 year, there was no difference between groups. All treatments were associated with large pre-treatment to post-treatment improvements, and results were maintained at 1-year follow-up. Conclusion No treatment was superior to the other regarding reducing sick leave. All treatments effectively reduced symptoms, CBT in a faster pace than RTW-I, but at 1-year follow-up, all groups had similar symptom levels. Further research is needed regarding how CBT and RTW-I can be combined more efficiently to produce a larger effect on sick leave while maintaining effective symptom reduction.

BackgroundWe reanalyzed data from a previously published randomized component study that aimed to test the incremental effect of systematic exposure in an internet-delivered cognitive behavioral treatment (ICBT) for irritable bowel syndrome (IBS).MethodsThree hundred and nine individuals with IBS were randomly assigned to either the full treatment protocol (experimental condition) or the same treatment protocol without systematic exposure (control). Participants were assessed weekly for IBS symptoms over the active treatment phase. We used a complier average causal effect (CACE) analysis, in the growth mixture modeling framework, to (1) examine the specific effect of exposure among those who received the intervention (i.e. compliers), and (2) explore the associations of pre-treatment patient characteristics with compliance status and outcome changes.ResultsFifty-five per cent of those assigned to the experimental condition were classified as compliers. The CACE analysis that took into account compliance status demonstrated that the magnitude of the incremental effect of systematic exposure on IBS symptoms was larger than the effect observed in an intention-to-treat analysis that ignored compliance status (d = 0.81 v. d = 0.44). Patients with university education showed more improvement during the exposure phase of the treatment. Pre-treatment patient characteristics did not predict compliance status.ConclusionsThe effect of systematic exposure on IBS symptoms is of substantial magnitude among those individuals who actually receive the intervention (CACE). Studying the subsample of individuals who discontinue treatment prematurely and tailoring interventions to improve compliance may increase overall improvement rates in ICBT for IBS.

Cognitive-behavioral therapy (CBT) has a solid evidence base as an effective treatment for depression. However, a recent meta-analysis (Johnsen & Friborg, 2015) including 70 studies, showed that the effect sizes of CBT for depression have been falling between 1977 and 2014. A possible important limitation in the Johnsen and Friborg (2015) study was that they did not investigate a leveling off in the decline over time of the effectiveness of CBT for depression. We therefore reanalyzed the data reported by Johnsen and Friborg (2015) using meta-analytic regression models that allowed for a curvilinear effect of publication year and also modeled separate estimates of the decline of treatment effect before and after 1995. Our analyses showed that adding a quadratic effect of time to a linear effect of time significantly improved the meta-analytic regression models (p = .017-.027). Furthermore, significant declines were only observed between 1977 and 1995 (p = .001-.009) and not between 1995 to 2014 (p = .987-.785). We conclude that the declining effect of CBT for depression observed by Johnsen and Friborg (2015) was highly influenced by 22 studies published before 1995 and that the 48 studies published after 1995 did not demonstrate such a decline. Thus, there are no indications that CBT for depression is gradually losing its value. (PsycINFO Database Record

Peripheral inflammation has been found associated with psychiatric disorders. However, results are inconclusive as to its role in common mental disorders (CMDs), i.e., depression, anxiety, insomnia and stress-related disorders. Further, some research suggests that cognitive behavior therapy (CBT) could reduce inflammatory markers in CMDs. In the present study, we measured pro-inflammatory cytokines (tumor necrosis factor alpha [TNF-α], interleukin-6 [IL-6] and IL-8) pre- and post-treatment in two clinical trials (N ​= ​367) investigating CBT for patients with CMDs in primary care. We hypothesized that higher levels of these cytokines would be associated with more severe psychiatric symptoms (i.e., symptoms of depression, stress and anxiety). We also hypothesized that level of cytokines would decrease after CBT and that the reduced levels would correlate with a reduction in symptoms. Results showed that in men, higher levels of TNF-α were associated with more severe psychiatric symptoms. Further, age moderated the association between TNF-α, as well as IL-6, and stress, and exploratory stratified analyses revealed significant associations in subgroups. No other significant associations between cytokines and psychiatric symptoms were found. None of the cytokines were reduced following CBT, and the marked improvements in psychiatric symptoms after treatment were not associated with changes in cytokines. In conclusion, although inflammation might be of relevance in subgroups, it seems to be of limited importance for clinical improvements across mild to moderate CMDs., Highlights • Immune dysregulation has been implicated in the etiology of common mental disorders. • Pro-inflammatory cytokines were measured pre and post cognitive behavior therapy. • Baseline associations between cytokines and symptoms were only found in subgroups. • Cytokine levels (TNF-α, IL-6 and IL-8) were not reduced after treatment. • Symptom improvement was not accompanied by reductions in cytokine levels.

Introduction: Health anxiety, also known as ‘hypochondriasis’, is a common, distressing and costly condition that responds to cognitive behavior therapy (CBT) but evidence pertaining to response and remission rates, treatment in routine care, therapist-guided Internet-delivered CBT (ICBT) and health economics has not been systematically reviewed. Areas covered: In this systematic review and meta-analysis we searched PubMed, PsycINFO, and OATD (17/06/2019) for randomized controlled trials (RCTs) comparing CBT to non-CBT controls for health anxiety. Based on 19 RCTs, the pooled between-group effect on health anxiety was moderate to large (g = 0.79; 95% CI: 0.57–1.01; adjusted for publication bias: g = 0.62), with small to moderate effects on secondary symptoms and effects largely sustained 12–18 months after treatment. Moderators were control condition and recruitment path, but not treatment setting. The pooled CBT response rate was 66%, and the remission rate 48%. ICBT had effects comparable to face-to-face CBT. CBT for health anxiety is probably cost-effective, but with limited effect on the quality of life. Expert opinion: CBT is a highly efficacious and probably cost-effective treatment for health anxiety. We recommend that ICBT is implemented more widely, and that health economic outcomes and ways of increasing response and remission rates are explored further.

Background Alcohol dependence is a common disorder with a continuum regarding severity. Most alcohol-dependent persons have a moderate level of dependence and live under socially orderly conditions. Treatment-seeking in this group is low, mainly due to stigma and because treatment options are seen as unappealing. Alcohol is a relevant topic to discuss in many primary care (PC) consultations and PC is less stigmatizing to visit compared to addiction care units for people with alcohol problems. However, general practitioners (GPs) hesitate to engage in treating alcohol problems due to time constraints and lack of knowledge. Screening and brief interventions are effective for high consumers but there are few studies on dependence. Methods This is a two-group, parallel, randomized controlled trial (RCT). The aim is to study whether an Internet-based Cognitive Behavioral Treatment (iCBT) when added to treatment as usual (TAU) is more effective than TAU only for alcohol dependence in PC. Two hundred and sixty adults with alcohol dependence will be included. Participants are randomized to iCBT and TAU or TAU only. The primary study outcome is alcohol consumption in grams per week and heavy-drinking days. Secondary outcomes include alcohol-related problem severity, number of diagnostic criteria for alcohol dependence, depression and anxiety symptoms, health-related quality of life and biochemical markers for high consumption and liver pathology. Data will be analyzed using mixed-effect models. Discussion Internet-based interventions are attractive to, and have been shown to reach, people with alcohol problems. Yet there are no studies investigating the efficacy of Internet treatment of alcohol dependence in PC. In this study we hypothesize that iCBT when added to TAU will improve treatment outcome for alcohol dependence in PC, compared to TAU only. If effective, iCBT can be distributed to the public to a low cost for a stakeholder and has the opportunity to reduce both short-term and long-term public health costs. Trial registration ISRCTN69957414. Retrospectively registered on 7 June 2018.

Major depressive disorder and the anxiety disorders are highly prevalent, disabling and moderately heritable. Depression and anxiety are also highly comorbid and have a strong genetic correlation (rg ≈ 1). Cognitive behavioural therapy is a leading evidence-based treatment but has variable outcomes. Currently, there are no strong predictors of outcome. Therapygenetics research aims to identify genetic predictors of prognosis following therapy. We performed genome-wide association meta-analyses of symptoms following cognitive behavioural therapy in adults with anxiety disorders (n = 972), adults with major depressive disorder (n = 832) and children with anxiety disorders (n = 920; meta-analysis n = 2724). We estimated the variance in therapy outcomes that could be explained by common genetic variants (h2SNP) and polygenic scoring was used to examine genetic associations between therapy outcomes and psychopathology, personality and learning. No single nucleotide polymorphisms were strongly associated with treatment outcomes. No significant estimate of h2SNP could be obtained, suggesting the heritability of therapy outcome is smaller than our analysis was powered to detect. Polygenic scoring failed to detect genetic overlap between therapy outcome and psychopathology, personality or learning. This study is the largest therapygenetics study to date. Results are consistent with previous, similarly powered genome-wide association studies of complex traits.

The aim of this study was to investigate insomnia symptom severity as a putative mediator of treatment response in therapist-guided internet-based cognitive behavioral therapy (ICBT) for chronic stress, using data from a randomized controlled trial. Participants (N = 100) were randomized to 12 weeks of ICBT or to a waitlist control condition (WLC). Insomnia severity was assessed weekly with the Insomnia Severity Index (ISI), as were the stress-related outcomes the Perceived Stress Scale (PSS) and the Shirom-Melamed Burnout Questionnaire (SMBQ). Latent growth models indicated that ICBT (vs. WLC) predicted a decrease in insomnia severity (α-path), and that growth in insomnia severity was predictive of growth in perceived stress and exhaustion (β-paths). Most importantly, there were also significant indirect effects (αβ products) such that the beneficial effects of ICBT on perceived stress and exhaustion were mediated by a reduction in insomnia symptom severity (PSS: αβ = −0.44, 95% CI [-0.92, −0.14]; SMBQ: αβ = −0.08, 95% CI [-0.15, −0.04]). Explorative analysis of moderated mediation showed that more severe insomnia symptoms at baseline were associated with larger mediated effects. We conclude that reducing insomnia severity could be of importance for achieving successful treatment outcomes in ICBT for chronic stress.

ObjectiveTo assess whether exposure-based internet-delivered cognitive–behavioural therapy (internet-CBT) is a cost-effective treatment for adolescents with irritable bowel syndrome (IBS) compared with a waitlist control, from a societal perspective, based on data from a randomised trial.DesignWithin-trial cost-effectiveness analysis.SettingParticipants were recruited from the whole of Sweden via primary, secondary and tertiary care clinics reached through news media and advertising.ParticipantsAdolescents (aged 13–17) with a diagnosis of IBS.InterventionsParticipants were randomised to either an exposure-based internet-CBT, including 10 weekly modules for adolescents and five modules for parents, or a waitlist.Outcome measuresThe main health outcome was the quality-adjusted life-year (QALY) estimated by mapping Pediatric Quality-of-Life Inventory (PedsQL) scores onto EQ-5D-3L utilities. The secondary outcome was the point improvement on the PedsQL scale. Data on health outcomes and resource use were collected at baseline and 10 weeks post-treatment. Resource use was measured using the Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) . Incremental cost-effectiveness ratios (ICER) were calculated as the difference in average costs by the difference in average outcomes between groups.ResultsThe base-case results showed that internet-CBT costs were on average US$170.24 (95% CI 63.14 to 315.04) more per participant than the waitlist. Adolescents in the internet-CBT group showed small QALY gains (0.0031; 95% CI 0.0003 to 0.0061), and an average improvement of 5.647 points (95% CI 1.82 to 9.46) on the PedsQL compared with the waitlist. Internet-CBT yielded an ICER of $54 916/QALY gained and a probability of cost-effectiveness of 74% given the Swedish willingness-to-pay threshold. The ICER for the outcome PedsQL was US$85.29/point improvement.ConclusionsOffering internet-CBT to adolescents with IBS improves health-related quality of life and generates small QALY gains at a higher cost than a waitlist control. Internet-CBT is thus likely to be cost-effective given the strong efficacy evidence, small QALY gains and low cost.Trial registration numberNCT02306369; Results.

Major depressive disorder is heritable and a leading cause of disability. Cognitive behavior therapy is an effective treatment for major depression. By quantifying genetic risk scores based on common genetic variants, the aim of this report was to explore the utility of psychiatric and cognitive trait genetic risk scores, for predicting the response of 894 adults with major depressive disorder to cognitive behavior therapy. The participants were recruited in a psychiatric setting, and the primary outcome score was measured using the Montgomery Åsberg Depression Rating Scale-Self Rated. Single-nucleotide polymorphism genotyping arrays were used to calculate the genomic risk scores based on large genetic studies of six phenotypes: major depressive disorder, bipolar disorder, attention-deficit/hyperactivity disorder, autism spectrum disorder, intelligence, and educational attainment. Linear mixed-effect models were used to test the relationships between the six genetic risk scores and cognitive behavior therapy outcome. Our analyses yielded one significant interaction effect (B = 0.09, p < 0.001): the autism spectrum disorder genetic risk score correlated with Montgomery Åsberg Depression Rating Scale-Self Rated changes during treatment, and the higher the autism spectrum disorder genetic load, the less the depressive symptoms decreased over time. The genetic risk scores for the other psychiatric and cognitive traits were not related to depressive symptom severity or change over time. Our preliminary results indicated, as expected, that the genomics of the response of patients with major depression to cognitive behavior therapy were complex and that future efforts should aim to maximize sample size and limit subject heterogeneity in order to gain a better understanding of the use of genetic risk factors to predict treatment outcome.

Background Severe health anxiety is a chronic and costly disorder if untreated. Patient self-referral may lower barriers to treatment and decrease diagnostic delay. Aims This study evaluated the accuracy of self-referral for severe health anxiety and compared characteristics of patients self-referred to internet-delivered treatment with patients referred by a clinician to face-to-face treatment. Method Two trials in the same clinic employed different referral methods for health anxiety, namely self-referral and clinician-referral (trial registration: clinicaltrials.gov: NCT01158430 and NCT02735434). The trials were conducted at different time points but with largely comparable eligibility criteria. The accuracy of the recruitment methods was compared by looking at the number of eligible patients in the two trials. Patients completed a baseline questionnaire and subsequently underwent a diagnostic interview by experienced clinicians. Mean differences in self-report and clinical data explored between-group demographic and clinical characteristics. Results In total, 101/151 (67%) self-referred patients were eligible compared with 126/254 (50%) clinician-referred patients (P = 0.001). Self-referred patients were 3.4 years older (P = 0.008) and had a somewhat higher educational level (P = 0.030). Patients who self-referred reported significantly higher levels of health anxiety, emotional distress and somatic symptoms compared with clinician-referred patients. Yet, they had less clinician-assessed comorbid anxiety disorders (PP Conclusions Self-referral was found to be an accurate method to recruit highly relevant patients with treatment-demanding health anxiety. Thus, both self-referral and clinician-referral seem feasible and valid referral methods, but they may recruit patients with slightly different characteristics. Declaration of interest None.

Internet-based cognitive behavior therapy (CBT) is a structured treatment that uses self-help texts, video clips, and audio files provided through an online platform to promote the same behavioral changes as in face-to-face CBT. In less than 10 years four randomized controlled trials have been published showing that Internet-based CBT can be an effective treatment for patients with health anxiety. Several aspects of the treatment, not least that it requires limited therapist resources compared to conventional CBT, makes it a promising option for increasing access to effective psychological treatment. Health economic studies indicate that this can be a highly cost-effective treatment that yields large improvements at no or low costs compared to no treatment. Given the high prevalence of health anxiety and the substantial suffering associated with the disorder, Internet-based CBT will probably be an important tool for improving mental health on a large scale in this patient group.

Health anxiety can be defined as a multifaceted trait that is primarily characterised by a fear of, or preoccupation with, serious illness. Whereas low levels of health anxiety can be helpful, clinically significant levels are associated with personal suffering and substantial societal costs. As general anxiety is probably on the rise, and the Internet has increased access to health-related information, it is commonly speculated that health anxiety has increased over the past decades. We tested this hypothesis based on a systematic review and meta-analysis of birth cohort mean health anxiety in Western university student samples from 1985 to 2017. Sixty-eight studies with 22 413 student participants were included. The primary analysis indicated that the mean score on the Illness Attitudes Scales had increased by 4.61 points (95 % CI: 1.02, 8.20) from 1985 to 2017. The percentage of general population Internet users in the study year of data collection was not predictive of student mean health anxiety. In conclusion, this study corroborates the hypothesis of an increase in health anxiety, at least in the student population, over the past decades. However, this increase could not be linked to the introduction of the Internet.

Atopic dermatitis (AD) is a common and debilitating inflammatory dermatological disorder and is marked by itch and inflamed skin. Scratching, sleep loss, and avoidance of situations associated with more AD symptoms are central hypothesized mechanisms that perpetuate the disorder and cause reduced quality of life. We developed an exposure-based cognitive behavioral treatment (CBT) that entailed mindfulness practice as a means to increase tolerance for aversive experiences during exposure. The aim of the present study was to test the treatment's acceptability and preliminary efficacy in adults with AD. We used an uncontrolled pretest-posttest design and recruited participants (

Background Severe health anxiety (hypochondriasis), or illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, is characterized by preoccupation with fear of suffering from a serious illness in spite of medical reassurance. It is a debilitating, prevalent disorder associated with increased health care utilization. Still, there is a lack of easily accessible specialized treatment for severe health anxiety. Objective The aims of this paper were to (1) describe the development and setup of a new internet-delivered acceptance and commitment therapy (iACT) program for patients with severe health anxiety using self-referral and a video-based assessment; and (2) examine the feasibility and potential clinical efficacy of iACT for severe health anxiety. Methods Self-referred patients (N=15) with severe health anxiety were diagnostically assessed by a video-based interview. They received 7 sessions of clinician-supported iACT comprising self-help texts, video clips, audio files, and worksheets over 12 weeks. Self-report questionnaires were obtained at baseline, post-treatment, and at 3-month follow-up. The primary outcome was Whiteley-7 Index (WI-7) measuring health anxiety severity. Depressive symptoms, health-related quality of life (HRQoL), life satisfaction, and psychological flexibility were also assessed. A within-group design was employed. Means, standard deviations, and effect sizes using the standardized response mean (SRM) were estimated. Post-treatment interviews were conducted to evaluate the patient experience of the usability and acceptability of the treatment setup and program. Results The self-referral and video-based assessments were well received. Most patients (12/15, 80%) completed the treatment, and only 1 (1/15, 7%) dropped out. Post-treatment (14/15, 93%) and 3-month follow-up (12/15, 80%) data were available for almost all patients. Paired t tests showed significant improvements on all outcome measures both at post-treatment and 3-month follow-up, except on one physical component subscale of HRQoL. Health anxiety symptoms decreased with 33.9 points at 3-month follow-up (95% CI 13.6-54.3, t11= 3.66, P=.004) with a large within-group effect size of 1.06 as measured by the SRM. Conclusions Treatment adherence and potential efficacy suggest that iACT may be a feasible treatment for health anxiety. The uncontrolled design and small sample size of the study limited the robustness of the findings. Therefore, the findings should be replicated in a randomized controlled trial. Potentially, iACT may increase availability and accessibility of specialized treatment for health anxiety. Trial Registration Danish Data Protection Agency, Central Denmark Region: 1-16-02-427-14; https://www.rm.dk/sundhed/faginfo/forskning/datatilsynet/ (Archived by Webcite at http://www.webcitation.org/6yDA7WovM)

Strategies to increase the availability of cognitive behaviour therapy (CBT) for severe health anxiety (SHA) are needed, and this study investigated the cost-effectiveness and long-term efficacy of three forms of minimal-contact CBT for SHA. We hypothesised that therapist-guided internet CBT (G-ICBT), unguided internet CBT (U-ICBT), and cognitive behavioural bibliotherapy (BIB-CBT) would all be more cost-effective than a waiting-list condition (WLC), as assessed over the main phase of the trial. We also hypothesised that improvements would remain stable up to one-year follow-up. Adults (N = 132) with principal SHA were randomised to 12 weeks of G-ICBT, U-ICBT, BIB-CBT, or WLC. The primary measure of cost-effectiveness was the incremental cost-effectiveness ratio, or the between-group difference in per capita costs divided by the between-group difference in proportion of participants in remission. The Health anxiety inventory (HAI) was the primary efficacy outcome. G-ICBT, U-ICBT, and BIB-CBT were more cost-effective than the WLC. Over the follow-up period, the G-ICBT and BIB-CBT groups made further improvements in health anxiety, whereas the U-ICBT group did not change. As expected, all three treatments were cost-effective with persistent long-term effects. CBT without therapist support appears to be a valuable alternative to G-ICBT for scaling up treatment for SHA.

Background The Health Anxiety Inventory (HAI), the Illness Attitude Scales (IAS), and the Whiteley Index (WI) are three of the most widely used health anxiety measures, but their psychometric properties have not been investigated when administered via the Internet. Methods We investigated the three instruments' test–retest reliability, internal consistency, convergent, and discriminant validity and sensitivity to change using one sample ( n = 111) of participants with severe health anxiety and one sample of healthy controls ( n = 92). Results The HAI, IAS, and WI showed high test–retest reliability ( r s ≥ .80), good convergent, and discriminant validity and were sensitive to detect change. The HAI and IAS ( α s ≥ .85), but not the WI ( α s ≤ .60) demonstrated high internal consistency. Conclusions The HAI, IAS, and WI have good psychometric properties, except for the low internal consistency of WI, when used as Internet-administered measures of health anxiety. Using these measures over the Internet offers highly important advantages such as increased ease of administration, reduced attrition, and cost-efficient treatment evaluation.

Objective: To explore how a student-run clinic (SRC) in primary health care (PHC) was perceived by students, patients and supervisors. Design: A mixed methods study. Clinical learning environment, supervision and nurse teacher evaluation scale (CLES + T) assessed student satisfaction. Client satisfaction questionnaire-8 (CSQ-8) assessed patient satisfaction. Semi-structured interviews were conducted with supervisors. Setting: Gustavsberg PHC Center, Stockholm County, Sweden. Subjects: Students in medicine, nursing, physiotherapy, occupational therapy and psychology and their patients filled in questionnaires. Supervisors in medicine, nursing and physiotherapy were interviewed. Main outcome measures: Mean values and medians of CLES + T and CSQ-8 were calculated. Interviews were analyzed using content analysis. Results: A majority of 199 out of 227 student respondents reported satisfaction with the pedagogical atmosphere and the supervisory relationship. Most of the 938 patient respondents reported satisfaction with the care given. Interviews with 35 supervisors showed that the organization of the SRC provided time and support to focus on the tutorial assignment. Also, the pedagogical role became more visible and targeted toward the student’s individual needs. However, balancing the student’s level of autonomy and the own control over care was described as a challenge. Many expressed the need for further pedagogical education. Conclusions: High student and patient satisfaction reported from five disciplines indicate that a SRC in PHC can be adapted for heterogeneous student groups. Supervisors experienced that the SRC facilitated and clarified their pedagogical role. Simultaneously their need for continuous pedagogical education was highlighted. The SRC model has the potential to enhance student-centered tuition in PHC.Key Points Knowledge of student-run clinics (SRCs) as learning environments within standard primary health care (PHC) is limited. We report experiences from the perspectives of students, their patients and supervisors, representing five healthcare disciplines. Students particularly valued the pedagogical atmosphere and the supervisory relationship. Patients expressed high satisfaction with the care provided. Supervisors expressed that the structure of the SRC supported the pedagogical assignment and facilitated student-centered tuition – simultaneously the altered learning environment highlighted the need for further pedagogical education. Student-run clinics in primary health care have great potential for student-regulated learning.

Background: Evidence-based practice for healthy lifestyle promotion in primary health care is supported internationally by national policies and guidelines but implementation in routine primary health care has been slow. Referral to digital interventions could lead to a larger proportion of patients accessing structured interventions for healthy lifestyle promotion, but such referral might have unknown implications for clinicians with patients accessing such interventions. This qualitative study aimed to explore the perceptions of clinicians in primary care on healthy lifestyle promotion with or without digital screening and intervention. Methods: Focus group interviews were conducted at 10 primary care clinics in Sweden with clinicians from different health professions. Transcribed interviews were analyzed using content analysis, with inspiration from a phenomenological-hermeneutic method involving naive understanding, structural analysis and comprehensive understanding. Results: Two major themes captured clinicians perceptions on healthy lifestyle promotion: 1) the need for structured professional practice and 2) deficient professional practice as a hinder for implementation. Sub-themes in theme 1 were striving towards professionalism, which for participants meant working in a standardized fashion, with replicable routines regardless of clinic, as well as being able to monitor statistics on individual patient and group levels; and embracing the future with critical optimism, meaning expecting to develop professionally but also being concerned about the consequences of integrating digital tools into primary care, particularly regarding the importance of personal interaction between patient and provider. For theme 2, sub-themes were being in an unmanageable situation, meaning not being able to do what is perceived as best for the patient due to lack of time and resources; and following ones perception, meaning working from a gut feeling, which for our participants also meant deviating from clinical routines. Conclusions: In efforts to increase evidence-based practice and lighten the burden of clinicians in primary care, decision-and policy-makers planning the introduction of digital tools for healthy lifestyle promotion will need to explicitly define their role as complements to face-to-face encounters. Our overriding hope is that this study will contribute to maintaining meaningfulness in the patient-clinician encounter, when digital tools are added to facilitate patient behavior change of unhealthy lifestyle behaviors. Funding Agencies|Stockholm County Council (PPG project for patient-focused research and development in Primary Care, Psychiatry and Geriatrics) [20140487]; Swedish Research Council [K2012-61X-22132-01-6, K2012-61P-22131-01-6]; Karolinska Institutet; Stockholm County Council

Background Nonsuicidal self-injury (NSSI) is common among adolescents and associated with negative outcomes. However, treatments developed specifically for NSSI and the proposed NSSI disorder (NSSID) are scarce, and access to empirically supported treatments for NSSI in many areas is limited. Online treatments carry the potential to increase the availability of evidence-based treatments. Emotion regulation individual therapy for adolescents (ERITA) has shown promise in the treatment of adolescents with NSSID. Method The present study examined the feasibility, acceptability, and utility of an online version of ERITA. Twenty-five adolescents (aged 13–17) with NSSID and their parents were included in an uncontrolled open trial. Self-report and clinician-rated assessments of outcomes such as NSSI, self-destructive behaviors, emotion dysregulation, and global functioning were administered at pre-treatment, post-treatment, 3- and 6- month follow-up. Measures of NSSI, self-destructive behaviors, and emotion dysregulation were also assessed weekly during treatment. Results Ratings of treatment credibility, expectancy, and satisfaction were acceptable, and the therapeutic alliance and treatment completion rate (96%) were high. Adolescent participation in the treatment was associated with a statistically significant increase in past-month NSSI abstinence (p = .007), large-sized improvements in past-month NSSI frequency (55% reduction, 95% confidence interval [CI]: 29, 72; Cohen’s d = 0.88, 95% CI: 0.73, 1.06) and global functioning (d = 1.01, 95% CI: 0.77, 1.32), and medium-sized improvements in emotion dysregulation (d = 0.75, 95% CI: 0.59, 0.90) and NSSI versatility (d = 0.63, 95% CI: 0.54, 0.77) from pre- to post-treatment. These improvements were further strengthened at 3-month follow-up and maintained at 6-month follow-up. The online therapist-guided parent program was associated with small- to large-sized (ds = 0.47–1.22) improvements in adaptive parent behaviors, and these improvements were maintained or further improved upon at 6-month follow-up. Moreover, in line with the theoretical model underlying ERITA, change in emotion dysregulation mediated changes in both NSSI frequency and self-destructive behaviors over the course of treatment. Conclusions Together, results suggest that online ERITA is an acceptable, feasible, and promising low-intensity treatment for adolescents with NSSID. The results of this open trial must be replicated in controlled studies. Trial registration ClinicalTrials.gov (NCT02697019). Registered 2 March 2016 Electronic supplementary material The online version of this article (10.1186/s12888-018-1885-6) contains supplementary material, which is available to authorized users.

Internet-based cognitive behavior therapy (ICBT) for obsessive-compulsive disorder (OCD) has shown efficacy in randomized trials but many patients do not respond to the treatment, we therefore need ...

Cognitive behavior therapy (CBT) is an effective treatment for OCD when delivered face-to-face, in group-format and also via the internet. However, despite overall large effect sizes, a considerabl ...

Background: Prolonged exposure to stress can lead to substantial suffering, impairment and societal costs. However, access to psychological treatment is limited. Internet-based cognitive behavioral therapy (ICBT) can be effective in reducing symptoms of stress, but little is known of its effects in clinical samples. The aim of this study was to investigate the efficacy of ICBT for patients suffering from chronic stress, operationalized as adjustment disorder (AD) and exhaustion disorder (ED). Methods: A total of 100 adults diagnosed with AD or ED were randomly assigned to a 12-week ICBT (n = 50) or waitlist control condition (n = 50). Primary outcome was the level of perceived stress (PSS). Secondary outcomes included several mental health symptom domains as well as functional impairment and work ability. All outcomes were assessed at baseline, after treatment and at the 6-month follow-up. The study was preregistered at Clinicaltrials.gov: NCT02540317. Results: Compared to the control condition, patients in the ICBT group made large and significant improvements on the PSS (d = 1.09) and moderate to large improvements in secondary symptom domains. Effects were maintained at the 6-month follow-up. There was no significant between-group effect on functional impairment or work ability. Conclusions: A relatively short ICBT is indicated to be effective in reducing stress-related symptoms in a clinical sample of patients with AD and ED, and has the potential to substantially increase treatment accessibility. Results must be replicated, and further research is needed to understand the relationship between symptom reduction, functional impairment and work ability.

BackgroundCommon mental disorders (CMD) cause large suffering and high societal costs. Cognitive behavioural therapy (CBT) can effectively treat CMD, but access to treatment is insufficient. Guided self-help (GSH) CBT, has shown effects comparable with face-to-face CBT. However, not all patients respond to GSH, and stepping up non-responders to face-to-face CBT, could yield larger response rates. The aim was to test a stepped care model for CMD in primary care by first evaluating the effects of GSH-CBT and secondly, for non-responders, evaluating the additional effect of face-to-face CBT.MethodsConsecutive patients (N = 396) with a principal disorder of depression, anxiety, insomnia, adjustment or exhaustion disorder were included. In Step I, all patients received GSH-CBT. In Step II, non-responders were randomized to face-to-face CBT or continued GSH. The primary outcome was remission status, defined as a score below a pre-established cutoff on a validated disorder-specific scale.ResultsAfter GSH-CBT in Step I, 40% of patients were in remission. After Step II, 39% of patients following face-to-face CBT were in remission compared with 19% of patients after continued GSH (p = 0.004). Using this stepped care model required less than six therapy sessions per patient and led to an overall remission rate of 63%.ConclusionsStepped care can be effective and resource-efficient to treat CMD in primary care, leading to high remission rates with limited therapist resources. Face-to-face CBT speeded up recovery compared with continued GSH. At follow-ups after 6 and 12 months, remission rates were similar in the two groups.

Purpose National initiatives, such as the UK Improving Access to Psychological Therapies program (IAPT), demonstrate the feasibility of conducting empirical mental health assessments on a large scale, and similar initiatives exist in other countries. However, there is a lack of international consensus on which outcome domains are most salient to monitor treatment progress and how they should be measured. The aim of this project was to propose (1) an essential set of outcome domains relevant across countries and cultures, (2) a set of easily accessible patient-reported instruments, and (3) a psychometric approach to make scores from different instruments comparable. Methods Twenty-four experts, including ten health outcomes researchers, ten clinical experts from all continents, two patient advocates, and two ICHOM coordinators worked for seven months in a consensus building exercise to develop recommendations based on existing evidence using a structured consensus-driven modified Delphi technique. Results The group proposes to combine an assessment of potential outcome predictors at baseline (47 items: demographics, functional, clinical status, etc.), with repeated assessments of disease-specific symptoms during the treatment process (19 items: symptoms, side effects, etc.), and a comprehensive annual assessment of broader treatment outcomes (45 items: remission, absenteeism, etc.). Further, it is suggested reporting disease-specific symptoms for depression and anxiety on a standardized metric to increase comparability with other legacy instruments. All recommended instruments are provided online (www.ichom.org). Conclusion An international standard of health outcomes assessment has the potential to improve clinical decision making, enhance health care for the benefit of patients, and facilitate scientific knowledge. Electronic supplementary material The online version of this article (doi:10.1007/s11136-017-1659-5) contains supplementary material, which is available to authorized users.

Background Major Depressive Disorder (MDD) is a serious, but treatable, disorder where Cognitive Behavioral Therapy (CBT) is a first line treatment. However, a significant number of patients (40–60%) are not responding to treatment and understanding more about the disorder and who responds to treatment is crucial to improve outcomes. In the past year, there have been marked advances in the genomics of MDD thanks to large consortia GWAS efforts. Here we leverage summary statistics derived from the latest MDD GWAS in order to test whether individual MDD polygenic risk scores (PRS) associate with baseline severity and CBT response in a sample of 971 MDD cases undergoing internet-based CBT (iCBT). Our aim is to calculate MDD Polygenic Risk Scores (PRS) and examine their relationship with a key measure of disease severity and treatment response with longitudinal follow up data. Methods We collected DNA from 971 Swedish MDD cases (66% female) who took part in a 12-week course of iCBT. The primary outcome variable was the Montgomery Asberg Depression Rating Scale – Self-rating (MADRS-S) and was measured pre-treatment, weekly, post treatment and at 6 months follow-up. For genotyping, the Illumina Global Screening Array (GSA) was used for the 971 samples. For population-specific controls, we will calculate MDD PRS for a set of 3,000 Swedish individuals with no history of MDD. We use the latest MDD summary statistics to calculate PRS for each individual to examine the relationship between polygenic load and a key measure of disease severity and treatment response. Further, we calculate PRS for a range of other traits which may influence disease severity or treatment response: neuroticism, bipolar disorder, subjective well-being and educational attainment. Results We will present results detailing the relationship between MDD PRS and disease severity (baseline MADRS) as well as treatment response (change in MADRS following iCBT) and treatment adherence. Further, we will present results demonstrating how PRS for a range of other traits influence disease severity or treatment response. Discussion In other psychiatric disorders, such as schizophrenia, polygenic risk score analyses and treatment response of pharmacological interventions have been investigated with interesting outcomes. In our future work, we will contrast genetic predictors with non-genetic predictors derived from the Swedish registers (e.g. pre- and perinatal risk factors), to try to understand even more about the biological underpinnings of MDD and response to treatment. We believe performing these analyses will bring us one step closer to determining whether genomics can help personalize MDD treatment.

Social anxiety disorder (SAD) is common, debilitating and associated with high societal costs. The disorder can be effectively treated with Internet-based cognitive behavior therapy (ICBT), but no previous study has investigated the long-term clinical or health economic effects of ICBT for SAD in comparison to an evidence-based control treatment. The aim of the study was to investigate the clinical effectiveness and cost-effectiveness of ICBT compared to cognitive behavioral group therapy (CBGT) four years post-treatment. We conducted a 4-year follow-up study of participants who had received ICBT or CBGT for SAD within the context of a randomized controlled non-inferiority trial. The cost-effectiveness analyses were conducted taking a societal perspective. Participants in both treatment groups made large improvements from baseline to 4-year follow-up on the primary outcome measure (d = 1.34-1.48) and the 95% CI of the mean difference on the primary outcome was well within the non-inferiority margin. ICBT and CBGT were similarly cost-effective and both groups reduced their indirect costs. We conclude that ICBT for SAD yields large sustainable effects and is at least as long-term effective as CBGT. Intervention costs of both treatments are offset by net societal cost reductions in a short time.

An internet-delivered cognitive behavioral treatment (ICBT) based on systematic exposure exercises has previously shown beneficial effects for patients with irritable bowel syndrome (IBS). Exposure exercises may be perceived as difficult for patients to perform because of the elicited short-term distress and clinicians may be reluctant to use these interventions. The aim of this study was to compare ICBT with the same protocol without systematic exposure (ICBT-WE) to assess if exposure had any incremental value. This randomized controlled dismantling study included 309 participants diagnosed with IBS. The treatment interventions lasted for 10 weeks and included online therapist contact. ICBT-WE comprised mindfulness, work with life values, acceptance, and encouraged reduced avoidance behaviors, while ICBT also included systematic exposure to IBS symptoms and related situations. Severity of IBS symptoms was measured with the Gastrointestinal Symptom Rating Scale - IBS version (GSRS-IBS). The between-group Cohen's d on GSRS-IBS was 0.47 (95% CI: 0.23-0.70) at post-treatment and 0.48 (95% CI: 0.20-0.76) at 6-month follow-up, favoring ICBT. We conclude that the systematic exposure included in the ICBT protocol has incremental effects over the other components in the protocol. This study provides evidence for the utility of exposure exercises in psychological treatments for IBS.

Fibromyalgia (FM) is a prevalent chronic pain disorder associated with large suffering and substantial societal costs. Pain-related avoidance behaviour and hypervigilance to bodily symptoms are common in FM and contribute in maintaining and exacerbating the disorder. Exposure therapy targeting avoidance behaviours and hypervigilance has shown promise in the treatment of FM. The present study investigated mediators of treatment outcome in exposure therapy for FM. We used data from a randomised trial, where 140 participants were allocated to 10-week internet-delivered exposure therapy or to a waiting-list control condition. The main outcome variable (FM symptoms) and the hypothesized mediators (FM-related avoidance behaviour, mindful non-reactivity and FM-related worry) were measured weekly throughout treatment. Mediation analyses were conducted using linear mixed effects models with bootstrap replication and time-lagged analysis. Results indicated that all three process variables were significant mediators of FM severity. However, in the time-lagged analyses, only FM-related avoidance behaviour displayed a unidirectional relationship over time with FM symptoms, suggesting a causal effect. Thus, results illustrate that changes in avoidance behaviour mediate the outcome of exposure on FM symptoms, which implies that avoidance behaviour is an important treatment target in exposure therapy.

Background & Aims: Scalable and effective treatments are needed for children with functional abdominal pain disorders (FAPDs). We performed a randomized controlled trial of the efficacy and cost effectiveness of cognitive behavioral therapy delivered online (Internet-CBT) compared with usual therapy. Methods: We studied children (age, 8–12 y) diagnosed with FAPDs, based on the Rome IV criteria, in Sweden from September 2016 through April 2017. The patients were assigned randomly to groups that received 10 weeks of therapist-guided, internet-delivered cognitive behavioral therapy (Internet-CBT, n = 46) or treatment as usual (treatments within the health care and school systems, including medications and visits to doctors and other health care professionals; n = 44). The primary outcome was global child-rated gastrointestinal symptom severity assessed using the Pediatric Quality of Life Gastrointestinal Symptom scale. All outcomes were collected from September 2016 through January 2018. Secondary outcomes included quality of life, gastrointestinal-specific anxiety, avoidance behaviors, and parental responses to children's symptoms. Societal costs and costs for health care consumption were collected during the treatment. Results: Children who received Internet-CBT had a significantly larger improvement in gastrointestinal symptom severity with a medium effect size (Cohen's d = 0.46; 95% CI, 0.05–0.88; number needed to treat, 3.8) compared with children who received the treatment as usual. The children's quality of life, gastrointestinal-specific anxiety, avoidance behaviors, and parental responses to children's symptoms also improved significantly in the Internet-CBT group compared with the treatment as usual group. The effects of Internet-CBT persisted through 36 weeks of follow-up evaluation. Children who received Internet-CBT had significantly less health care use than children who received treatment as usual, with an average cost difference of US $137 (P = .011). We calculated a cost savings of US $1050 for every child treated with Internet-CBT compared with treatment as usual. Conclusions: In a randomized trial of pediatric patients with FAPDs, we found Internet-CBT to be clinically cost effective compared with treatment as usual. Internet-CBT has the potential to increase the availability of treatment for a number of patients and reduce health care costs. ClinicalTrials.gov: NCT02873078.

Background Stress-related disorders are associated with significant suffering, functional impairment, and high societal costs. Internet-based cognitive behavioral therapy (ICBT) is a promising treatment for stress-related disorders but has so far not been subjected to health economic evaluation. Objective The objective of this study was to evaluate the cost-effectiveness and cost-utility of ICBT for patients with stress-related disorders in the form of adjustment disorder (AD) or exhaustion disorder (ED). We hypothesized that ICBT, compared with a waitlist control (WLC) group, would generate improvements at low net costs, thereby making it cost-effective. Methods Health economic data were obtained in tandem with a randomized controlled trial of a 12-week ICBT in which patients (N=100) were randomized to an ICBT (n=50) or a WLC (n=50) group. Health outcomes and costs were surveyed pre- and posttreatment. We calculated incremental cost-effectiveness ratios (ICERs) based on remission rates and incremental cost-utility ratios (ICURs) based on health-related quality of life. Bootstrap sampling was used to assess the uncertainty of our results. Results The ICER indicated that the most likely scenario was that ICBT led to higher remission rates compared with the WLC and was associated with slightly larger reductions in costs from pre- to posttreatment. ICBT had a 60% probability of being cost-effective at a willingness to pay (WTP) of US $0 and a 96% probability of being cost-effective at a WTP of US $1000. The ICUR indicated that ICBT also led to improvements in quality of life at no net societal cost. Sensitivity analyses supported the robustness of our results. Conclusions The results suggest that ICBT is a cost-effective treatment for patients suffering from AD or ED. Compared with no treatment, ICBT for these patients yields large effects at no or minimal societal net costs. Trial Registration ClinicalTrials.gov NCT02540317; https://clinicaltrials.gov/ct2/show/NCT02540317

Internet-based cognitive behavior therapy (CBT) for severe health anxiety can be effective, but not all patients achieve full remission. Under these circumstances, knowledge about predictors is essential for the clinician in order to make reliable treatment recommendations. The primary aim of this study was to investigate clinical, demographic, and therapy process-related predictors of Internet-based CBT for severe health anxiety. We performed three types of analyses on data from a sample comprising participants (N = 81) who had received Internet-based CBT in a randomized controlled trial. Outcomes were a) end state health anxiety, b) improvement in health anxiety (continuous change scores), and c) clinically significant improvement. Outcomes were assessed at six-month follow-up. The results showed that the most stable predictors of both end state health anxiety and improvement were baseline health anxiety and depressive symptoms. Treatment adherence, i.e. the number of completed treatment modules, also significantly predicted outcome. Notably, health anxiety at baseline was positively associated with symptom improvement while depressive symptoms was negatively related to improvement. Demographic factors were largely without significant impact on end state symptoms or improvement. We conclude that baseline symptom burden and adherence to treatment have strong predictive effects in Internet-based CBT for severe health anxiety.