Abstract Introduction Cognitive ability has been linked to posttraumatic stress disorder (PTSD) vulnerability and may influence trauma-focused treatment response, yet its role in youth Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) outcomes remains unclear. Clarifying this issue is relevant for equitable access to evidence-based care. We examined whether formally assessed IQ was associated with PTSD symptom change from pre- to post-treatment based on youth and caregiver reports and with treatment dropout in children and adolescents undergoing TF-CBT after abuse or neglect. Method Data came from N = 320 youth aged 5–21 years from a randomized clinical effectiveness trial. Intelligence quotient (IQ) was assessed with standardized tests, PTSD symptoms with the Child and Adolescent Trauma Screen (CATS-2), and dropout was defined as not completing therapy as intended. Symptom change was calculated as post- (T1) minus pre-treatment (T0) and evaluated separately for youth and caregiver reports. Regression models included age, gender, baseline PTSD severity, and treatment satisfaction assessed after treatment as an additional model variable. Results Mean IQ was M = 97.41 ( SD = 13.19, range = 51–138). PTSD severity was high at baseline ( M = 34.21, SD = 8.09) and decreased substantially (ΔCATS-2 T1 ₋ T0 youth report: M = −17.54, SD = 12.34; Cohen’s d paired = 1.42). IQ showed small but significant negative correlations with symptom change in youth reports ( r = −.14, p = .040) and caregiver reports ( r = −.17, p = .018), indicating greater symptom reductions at higher IQ. In regressions, IQ was not a significant predictor in the youth-report model (β = −.10, p = .077), while a small effect remained in the caregiver-report model (β = −.15, p = .011). Baseline PTSD severity and post-treatment satisfaction showed more consistent associations with symptom reduction. Dropout was 29.1%. IQ neither differed between completers and dropouts nor was associated with dropout in logistic regression (OR = 0.99, p = .536), whereas higher post-treatment satisfaction was associated with lower dropout risk. Discussion TF-CBT was associated with substantial symptom reductions across the observed IQ range, suggesting its suitability for routine care without excluding youth solely on the basis of cognitive ability. Baseline severity and treatment satisfaction at post-treatment showed stronger associations with symptom change and dropout than IQ. Trial registration The BESTFORCAN study was registered in the German Clinical Trial Registry (DRKS00020516) on 12 February 2020.

Internet-based psychological interventions can effectively reduce depressive symptoms in adults, but adherence remains challenging. In this preregistered individual participant data meta-analysis, we examined predictors of treatment adherence. We searched PubMed, Embase and PsycINFO on 6 February 2024 for randomized trials of internet-based interventions among adults with elevated depressive symptoms. We conducted a one-stage logit-link multilevel beta regression, with adherence defined as the proportion of completed modules post-intervention. This study included 71 trials (85 treatment arms, 8,082 participants). Lower adherence was associated with younger age (β = 0.005, standard error (SE) 0.002, P = 0.028), male gender (β = −0.163, SE 0.053, P = 0.002), lower education (β = −0.133, SE 0.05, P = 0.008) and employment (β = −0.113, SE 0.054, P = 0.037). No significant interactions were found between individual predictors and intervention format (guided versus self-guided). Higher adherence was associated with lower post-intervention depression severity, adjusting for baseline severity (β = −0.30, SE 0.04, P < 0.001). Identifying subgroups at risk of low adherence may inform targeted strategies to improve engagement and clinical effectiveness. Using data from 71 randomized controlled trials that involve 8,082 participants, the authors of this individual participant data meta-analysis examine individual- and study-level predictors of adherence to internet-based interventions for depression.

BACKGROUND:People with chronic pain are confronted with limited access to established forms of treatment. Acceptance and commitment therapy (ACT) has been found to be an effective extension of cognitive behavioral therapy (CBT) for chronic pain. In this study, we evaluated the ACT-based online therapy program HelloBetter Chronic Pain in a clinical sample of patients with chronic pain in Germany. METHODS:In a randomized, controlled, and investigator-blinded trial, the program was tested against a treatment-as-usual control group (waiting list). HelloBetter Chronic Pain comprises a sequence of seven units with interactive content and audio, video, and textual elements. Written support was delivered by psychotherapists (in training) based on standardized templates incorporating automated components. 360 patients with a medically confirmed diagnosis of chronic pain were included in the trial. The primary endpoint was the degree of pain interference (on the interference scale of the Multidimensional Pain Inventory) at 12 weeks. The efficacy analysis was based on linear regression models (intention to treat [ITT], multiple imputation). RESULTS:At 12 weeks, the patients in the intervention group exhibited significantly lower pain interference scores (d = 0.69; 95% confidence interval: [0.46; 0.92]) than those in the control group; they also had fewer depressive symptoms (d = 0.40; [0.17; 0.63]) and experienced better health-related quality of life (d = -0.23; [-0.40; -0.06). These effects were still present at 6 and 12 months. CONCLUSION:HelloBetter Chronic Pain effectively and sustainably reduces impairment by pain to a clinically relevant extent, alleviates symptoms overall, and may contribute to the successful implementation of guideline-based care for patients with chronic pain.

The college stage is marked by high prevalence of mental disorders, particularly anxiety, low mood, and substance abuse. Despite this, many affected students do not receive treatment, underscoring the need for preventive strategies. In respose, the CORE program, an internet-based intervention, was developed to enhance resilience and coping skills among college students. The present study, part of the ICare project (EU-634757), aims to assess the effectiveness of the CORE intervention in improving resilience and reducing symptoms of anxiety and depression in comparison to a Waiting List (WL) condition. The study was registered at ISRCTN (ISRCTN13856522). In the study the unguided internet-based intervention (CORE) was compared to a WL control group in a multicenter two-arm, single-blind, randomized controlled trial (RCT) conducted in Spain, Germany, and Switzerland. Questionnaire based evaluations occurred at baseline (BL), 8 weeks (post-intervention), 6 and 12 months after randomization. A total of 493 students with low levels of resilience participated in the study. Participants in the intervention group gained access to an internet-based program aiming to enhance resilience by learning to cope with stressors in daily life, promote self-empowerment, and improve well-being. Participants were instructed to engage in six interactive modules delivered weekly in a sequential order. The program's therapeutic content was developed following the Ryff model of well-being. The primary outcome measure used was the Connor-Davidson Resilience Scale (CD-RISC-25). Additionally, anxiety and depressive symptomatology, coping strategies, and well-being were measured. Participants in the CORE condition reported a significant increase in resilience compared to WL condition (Differences post-BL: d = 0.34, p = .0005; 6 M-BL: d = 0.24, p = .0171; 12 M-BL: d = 0.33, p = .0031). Although, a general time trend towards improvement in the resilience was observed in both groups. Participants in the CORE condition, compared to those in the WL condition, showed a significant reduction in anxiety symptoms in the short and long term (differences post-BL: d = 0.30, p = .0015; 6 M-BL: d = 0.18, p = .0857; 12 M-BL: d = 0.23, p = .0312) and depression in the short term. Furthermore, participants in CORE condition showed a significant improvement in positive functioning measurements, such as well-being and self-compassion compared to WL condition. (Differences post-BL: d = 0.25, p = .0123; 6 M-BL: d = 0.16, p = .1505; 12 M-BL: d = 0.13, p = .1835). Adherence to fully complete the intervention was approximately 59 %. In conclusion, our study revealed promising outcomes for the CORE program, indicating its efficacy. These results position the CORE program as a valuable and validated tool in fostering resilience, offering promising ways for addressing mental health challenges in academic settings.

INTRODUCTION:Negative effects of psychotherapy encompass unwanted events caused by the treatment. Evidence exists that cognitive behavioral therapy for insomnia (CBT-I) can lead to negative effects (e.g., exhaustion, reduced motivation). Psychometrically validated instruments are needed to enable systematic investigation of negative effects and their consequences. This study aimed to develop an insomnia-specific extension for the Negative Effect Questionnaire (NEQ) and to evaluate its psychometric properties. METHOD:Based on a literature review, an item pool was developed as an extension to the NEQ. This item pool was iteratively refined. Both the NEQ and the developed item pool were administered to participants enrolled in a stepped-care model for insomnia that includes an internet-delivered CBT-I. The psychometric properties of the item pool were evaluated using confirmatory factor analyses (CFAs). Additionally, responses to open-ended questions were categorized and analyzed. RESULTS:Data from 210 participants were available. In the newly developed item pool, participants reported a mean of 4.7 negative effects (range: 0 to 22). CFA indicated a good fit (RSMEA = 0.05; SRMR = 0.07) of a model with five latent factors (somatic symptoms, cognitive symptoms, safety, emotional symptoms, daytime functioning). The correlation analyses between the model's latent factors and the NEQ subscales indicated adequate discriminant validity. DISCUSSION:The observed prevalence rates of insomnia-specific negative effects highlight the need to assess the negative effects of CBT-I with an insomnia-specific instrument. The CFA suggests that the 24-item NEQ-Insomnia is a valid instrument, suitable for standalone use or as an extension to the NEQ for assessing the negative effects of CBT-I.

Sleep Restriction Therapy (SRT) is a core component of cognitive behavioural therapy for insomnia (CBT-I). Yet, adherence to SRT can be a major challenge for patients. As this challenge is evident in conventional face-to-face therapy, it raises the question of adherence to SRT in internet-delivered therapy. This qualitative study investigates adherence to SRT in internet-delivered CBT-I and aims to identify candidate variables that can guide treatment decisions. Participants diagnosed with insomnia who participated in an internet-delivered CBT-I as part of a stepped-care model were interviewed. Data from interviews with 23 participants were included in this study. A qualitative content analysis was employed. Hindering and facilitating individual, intervention-related, and e-coaching-related factors were examined. Moreover, the consequences of SRT (e.g., negative effects and attrition) were examined. Eleven participants consistently implemented SRT, two rejected it from the beginning, eight discontinued, and two showed inconsistent adherence. Docility, low levels of frustration tolerance, and previous negative experiences with SRT emerged as hindering individual factors. In contrast, a high level of insomnia-related burden, social support, perceived individual fit with the program, and being satisfied with the therapeutic guidance appeared to foster adherence. Based on the results of this study, a treatment path model is introduced, postulating candidate predictors for the indication for SRT within internet-delivered CBT-I (e.g., docility and previous negative experiences with SRT), candidate predictors for engagement (e.g., level of commitment and social support), and potential variables for process monitoring (e.g., negative effects and satisfaction with and need for therapeutic guidance).

Introduction:Internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) is an effective treatment. However, dropout is a common challenge in digital therapeutics. This study examines dropout in iCBT-I by analyzing reported reasons for dropout and investigating whether baseline variables and intervention usage data can predict dropout. Methods:This is an exploratory secondary analysis of a clinical trial investigating a stepped care model for insomnia featuring an eight-module iCBT-I. Reasons for dropout from the iCBT-I were assessed via self-developed items in follow-up surveys, and a dropout survey was sent to all patients who had not completed at least seven modules of the iCBT-I within 12 weeks. The proportion of respondents who agreed with the respective items was calculated. Additionally, bivariate models were specified to explore whether baseline variables and intervention usage data can predict dropout. Results:The patients included in this sub-study had a mean age of 49.3 (SD=13.0), with 73.4 % identifying as female. At pre-treatment, their mean insomnia severity was 18.6 (SD=3.9). Among the 233 patients, 103 (44.2 %) were categorized as dropouts. The most frequently reported reasons for dropout were distractions from daily life, the perception of the content not being useful, and difficulties resuming after a break. None of the examined baseline variables significantly predicted dropout, whereas the time needed to complete the first module (OR=1.16; 95 %CI=1.08-1.27) and the number of sleep diary entries in the first week (OR=0.73; 95 %CI=0.65-0.80) significantly predicted dropout. Discussion:This study highlights dropout as a relevant challenge in iCBT-I, affecting over 40 % of patients. Self-reported reasons indicate the importance of compatibility with distractions from daily life and perceived effectiveness. The prediction models suggest that dropout risk profiles can be developed based on first-week treatment data. Future research should focus on validating such models to improve effectiveness and user retention.

BACKGROUND:It remains unclear which individuals with subthreshold depression benefit most from psychological intervention, and what long-term effects this has on symptom deterioration, response and remission. AIMS:To synthesise psychological intervention benefits in adults with subthreshold depression up to 2 years, and explore participant-level effect-modifiers. METHOD:Randomised trials comparing psychological intervention with inactive control were identified via systematic search. Authors were contacted to obtain individual participant data (IPD), analysed using Bayesian one-stage meta-analysis. Treatment-covariate interactions were added to examine moderators. Hierarchical-additive models were used to explore treatment benefits conditional on baseline Patient Health Questionnaire 9 (PHQ-9) values. RESULTS:IPD of 10 671 individuals (50 studies) could be included. We found significant effects on depressive symptom severity up to 12 months (standardised mean-difference [s.m.d.] = -0.48 to -0.27). Effects could not be ascertained up to 24 months (s.m.d. = -0.18). Similar findings emerged for 50% symptom reduction (relative risk = 1.27-2.79), reliable improvement (relative risk = 1.38-3.17), deterioration (relative risk = 0.67-0.54) and close-to-symptom-free status (relative risk = 1.41-2.80). Among participant-level moderators, only initial depression and anxiety severity were highly credible (P > 0.99). Predicted treatment benefits decreased with lower symptom severity but remained minimally important even for very mild symptoms (s.m.d. = -0.33 for PHQ-9 = 5). CONCLUSIONS:Psychological intervention reduces the symptom burden in individuals with subthreshold depression up to 1 year, and protects against symptom deterioration. Benefits up to 2 years are less certain. We find strong support for intervention in subthreshold depression, particularly with PHQ-9 scores ≥ 10. For very mild symptoms, scalable treatments could be an attractive option.

Adherence to digital health interventions remains a persistent challenge, limiting their effectiveness and motivating the need for scalable strategies that promote sustained engagement. This randomized controlled trial investigated whether user adherence could be enhanced by two specific persuasive design strategies: a gamification approach focused on visualizing skill progression, and a social support approach based on automated interaction between supportive partners. University students were recruited and assigned to a control, gamification, or social support group. The control group received the standard intervention without persuasive strategies, whereas the gamification group utilized skill-based progression systems and infographics. In the social support group, participants were paired into teams. Participants were encouraged to motivate teammates to complete daily diary entries, with mutual completion triggering a congratulatory email. Average module completions were: control ( M = 2.52 , SD = 1.92), gamification ( M = 2.69 , SD = 1.89), and social support ( M = 2.76 , SD = 2.03). Neither the gamification components nor the automated peer support system improved adherence compared to the control. Although the peer support strategy in the social support group recorded more diary entries, this did not translate to improved module adherence. User experience ratings were comparable in all groups, indicating that the strategies did not affect usability. The smaller-than-planned sample size and higher attrition rates warrant cautious interpretation of these findings. These results contribute to healthcare informatics by demonstrating the limitations of generic persuasive strategies and highlighting the need for more adaptive, context-aware engagement mechanisms in digital interventions.

Objective Research on effective implementation options and key factors in blending face-to-face (FTF) psychotherapy with online treatment elements (i.e., blended therapy, BT) remains limited. This study aimed to explore patients’ experiences and to identify relevant factors in implementing BT in routine care. Methods Qualitative semi-structured interviews were conducted with 40 patients (10.7% of N = 375) from the PSYCHOnlineTHERAPY trial. The patients were adults with diagnosed anxiety or depressive disorders and received one of two versions of BT based on cognitive behavioral therapy, differing in the flexibility to decide on the sequence and ratio of BT elements (FTF sessions and online self-help sessions). The interviews were audio-recorded, transcribed, and analyzed using a deductive-inductive qualitative content analysis approach, partly theory-based on the “Efficiency Model of Support.” Results The analysis revealed 163 theme codes, categorized into 30 subcategories. The main categories were “motivation and expectations,” “active components, mechanisms of change, and effects,” “blending scenarios,” “therapeutic alliance,” “negative effects,” “fit,” “facilitators and barriers for engagement and daily life transfer,” “usability,” and “optimization possibilities.” Key findings highlight positive outcomes of BT, the important role of the therapist, the transformative interaction of FTF and online sessions, and the distinctive functions and benefits of each element, suggesting BT's added value over stand-alone treatments. Various patient, therapeutic, and treatment characteristics emerged as relevant facilitators and barriers across different domains. Heterogeneity in patient preferences emphasized the importance of personalization. Conclusion Overall, these results provide valuable insights for the practical implementation and further research on BT. Trial registration German clinical trial register (DRKS00023973, date of registration: December 28, 2020), https://www.drks.de/search/de/trial/DRKS00023973 .

BackgroundInternet-based cognitive behavioral therapy for insomnia (iCBT-I) provides flexibility but requires significant time and includes potentially challenging components such as sleep restriction therapy. This raises questions about its incremental effectiveness compared to less demanding minimal interventions such as sleep hygiene psychoeducation. ObjectiveThis study aimed to assess the incremental efficacy of self-guided iCBT-I with optional on-demand feedback for university students with insomnia compared to a single session of digital psychoeducation on sleep hygiene. MethodsIn a randomized controlled trial, 90 students with insomnia (Insomnia Severity Index ≥10) were randomly allocated to self-help–based iCBT-I (45/90, 50%) or one session of digital sleep hygiene psychoeducation with stimulus control instructions (active control group [aCG]: 45/90, 50%). The self-help–based iCBT-I consisted of 6 sessions on psychoeducation, sleep restriction, and stimulus control, including written feedback on demand from an eCoach. Assessments occurred at baseline (T1), 8 weeks after treatment (T2), and at a 6-month follow-up (T3) via web-based self-assessment and diagnostic telephone interviews. The primary outcome was insomnia severity at T2. Analyses of covariance were conducted in an intention-to-treat sample. Secondary outcomes included diagnoses of insomnia and major depression, sleep quality, sleep efficiency, worrying, recovery experiences, recovery activities, presenteeism, procrastination, cognitive irritation, and recuperation in sleep. ResultsThere was no difference in insomnia severity at T2 between the iCBT-I group (mean 11.27, SD 5.21) and aCG group (mean 12.36, SD 4.16; F1,989.03=1.12; P=.29; d=–0.26; 95% CI 0.68 to 0.17). A significant difference emerged at T3 (iCBT-I: mean 9.43, SD 5.36; aCG: mean 12.44, SD 5.39; F1,426.15=4.72; P=.03), favoring iCBT-I with a medium effect (d=–0.57; 95% CI 1.07 to –0.06). Most secondary outcomes revealed no significant differences between the groups. In total, 51% (23/45) of participants in the iCBT-I group completed all 6 sessions, and 69% (31/45) completed the 4 core sessions. ConclusionsIn the short term, students might benefit from low-intensity, easily accessible digital sleep hygiene psychoeducation or iCBT-I. However, it appears that iCBT-I offers superiority over sleep hygiene psychoeducation in the long term. Trial RegistrationGerman Clinical Trials Register DRKS00017737; https://drks.de/search/de/trial/DRKS00017737

Introduction: Research on internet-interventions for youth with post-traumatic stress symptoms (PTSS) is limited, despite promising results in adults. A non-randomised feasibility study of a therapist-guided trauma-focused internet- and mobile-based intervention (IMI) showed potential in reducing PTSS but revealed challenges with adherence and individual fit. Insights from qualitative studies can enhance intervention quality by addressing personal needs. This study explores participants' views on the feasibility of a therapist-guided trauma-focused IMI to improve digital trauma interventions.Methods: Semi-structured interviews based on theoretical models of acceptance and human support in IMIs were conducted with 17 of 32 participants from a self-help-based trauma-focused IMI with therapist guidance. Audio-recorded interviews were transcribed and analyzed using deductive-inductive content analysis. Independent coding resulted in good agreement (κ = .76).Results: 20 themes were identified and organised under nine dimensions: participation motivation and expectations; recruitment process; treatment adherence and everyday use of therapeutic exercises; trauma processing; non-trauma processing intervention components; technology, structure, and design of the IMI; human support; individual fit; and active factors and efficacy. The technology, structure, and design of the IMI and other non-trauma-focused components were rated positively. Trauma processing presented challenges for many but was still perceived as a helpful and relevant active factor. Some felt a lack of therapeutic support, and greater personalisation of guidance was a frequent suggestion for improving the individual fit. The IMI's efficacy was most often perceived in its effects on improved coping with trauma and symptoms.Discussion: The study identified key themes for the feasibility of a trauma-focused IMI for youth, showing general acceptance of its design, structure, and technology. While trauma processing in IMIs poses challenges similar to face-to-face therapy, these can be addressed by clarifying the therapy rationale, making trauma processing an important active factor. Further research is needed to improve individualisation and therapeutic support intensity.Trial registration: German Clinical Trials Register identifier: DRKS00023341..

Farmers and related professionals are at risk of depression due to laborious work requirements, financial challenges, seasonal working conditions, high residence in under-resourced areas, and low help-seeking behavior. This study aimed to evaluate the long-term effectiveness of personalized telephone coaching in reducing depressive symptom severity and other mental health problems in farmers. Participating farmers with elevated depressive symptoms (PHQ-9 ≥ 5) were randomly allocated to receive up to six months of personalized telephone coaching (N = 160) or enhanced treatment-as-usual (TAU +) with psychoeducational material via mail (N = 154). The coaching was conducted by psychologists and personalized in terms of sessions frequency, duration, and content. Depressive symptom severity and other mental health and work-related outcomes were assessed at baseline, and long-term after 12 and 18 months. Group differences were determined by covariance analysis adjusting for baseline severity. Group differences were observed in favor of the telephone coaching compared to TAU + in depressive symptom severity (d12months = -0.34, d18months = -0.31), perceived stress (d12months = -0.41, d18months = -0.37), emotional exhaustion (d12months = -0.29, d18months = -0.28), and cynicism (d12months = -0.32, d18months = -0.34) at both follow-ups. Group differences in anxiety (d = -0.28) and quality of life (d = 0.30) were only observed at the 12-month assessment. No group differences were observed in depression onset, insomnia severity, panic and agoraphobia symptoms, alcohol consumption, professional efficiency, or self-reported prognosis of working capacity. Personalized telephone coaching as a promising remote prevention offer can reduce depressive symptom severity, generalized anxiety, perceived stress, emotional exhaustion, and cynicism, while additional support may be necessary to address aspects related to professional performance. Clinical trial registration: DRKS00015655

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

Introduction: Although evidence-based treatments for posttraumatic stress disorder (PTSD) in adolescents and young adults exist, affected youth do not have sufficient access to these treatments due to structural and attitudinal barriers. Internet- and mobile-based interventions (IMIs) can help fill this healthcare gap, but such programmes have not yet been sufficiently evaluated in youth with PTSD. Aim: This study aims to investigate the feasibility of an IMI for youth with PTSD in a one-arm, non-randomised, prospective proof-of-concept feasibility study. Methods: We aim to recruit 32 youth between 15 and 21 years old with clinically relevant posttraumatic stress symptoms (CATS ≥ 21), who will receive access to the IMI. The IMI consists of nine sessions involving psychoeducation, emotion regulation and coping skills, written-based imaginal exposure, cognitive restructuring and relapse prevention. Participants will be guided by an eCoach, who provides weekly semi-standardised written feedback on completed sessions and adherence reminders. We will use a formal feasibility framework to assess different dimensions of feasibility: (1) recruitment capability and resulting sample characteristics, (2) data collection procedures and outcome measures, (3) acceptability of the IMI and study procedures, (4) resources and ability to manage and implement the study and IMI and (5) participants’ responses to the IMI in terms of symptom severity and satisfaction. Additionally, potential negative effects related to the intervention will be assessed. Assessments take place pre-, mid- and post-intervention and at follow-up, including semi-structured clinical telephone interviews for PTSD diagnostics at pre- and post-intervention assessment. Qualitative interviews will be conducted to investigate the youth perspectives on the IMI. Discussion: This study aims to determine the feasibility of a guided IMI for youth with PTSD to adapt the IMI as closely as possible to youth needs and to inform the design, procedure and safety management of a large-scale efficacy RCT. Trial registration: German Clinical Trials Register identifier: DRKS00023341. HIGHLIGHTS Evidence-based care for adolescents after trauma is not widely available.• This study evaluates the feasibility of a guided trauma-focused Internet intervention as a time- and location-independent low-threshold treatment option for adolescents and young adults with posttraumatic stress disorder.

Background Stress is highly prevalent and known to be a risk factor for a wide range of physical and mental disorders. The effectiveness of digital stress management interventions has been confirmed; however, research on its economic merits is still limited. Objective This study aims to assess the cost-effectiveness, cost-utility, and cost-benefit of a universal digital stress management intervention for employees compared with a waitlist control condition within a time horizon of 6 months. Methods Recruitment was directed at the German working population. A sample of 396 employees was randomly assigned to the intervention group (n=198) or the waitlist control condition (WLC) group (n=198). The digital stress management intervention included 7 sessions plus 1 booster session, which was offered without therapeutic guidance. Health service use, patient and family expenditures, and productivity losses were self-assessed and used for costing from a societal and an employer’s perspective. Costs were related to symptom-free status (PSS-10 [Perceived Stress Scale] score 2 SDs below the study population baseline mean) and quality-adjusted life years (QALYs) gained. The sampling error was handled using nonparametric bootstrapping. Results From a societal perspective, the digital intervention was likely to be dominant compared with WLC, with a 56% probability of being cost-effective at a willingness-to-pay (WTP) of €0 per symptom-free person gained. At the same WTP threshold, the digital intervention had a probability of 55% being cost-effective per QALY gained relative to the WLC. This probability increased to 80% at a societal WTP of €20,000 per QALY gained. Taking the employer’s perspective, the digital intervention showed a probability of a positive return on investment of 78%. Conclusions Digital preventive stress management for employees appears to be cost-effective societally and provides a favorable return on investment for employers. Trial Registration German Clinical Trials Register DRKS00005699; https://drks.de/search/en/trial/DRKS00005699

INTRODUCTION:Farmers have a high risk for depression (MDD). Preventive measures targeting this often remotely living population might reduce depression burden. The study aimed to evaluate the effectiveness of personalized telephone coaching in reducing depressive symptom severity and preventing MDD in farmers compared to enhanced treatment as usual (TAU + ). METHODS:In a two-armed, pragmatic randomized controlled trial (N = 314) with post-treatment at 6 months, farming entrepreneurs, collaborating family members and pensioners with elevated depressive symptoms (PHQ-9 ≥ 5) were randomized to personalized telephone coaching or TAU + . The coaching was provided by psychologists and consists on average of 13 (±7) sessions a 48 min (±15) over 6 months. The primary outcome was depressive symptom severity (QIDS-SR16). RESULTS:Coaching participants showed a significantly greater reduction in depressive symptom severity compared to TAU + (d = 0.39). Whereas reliable symptom deterioration was significantly lower in the intervention group compared to TAU + , no significant group differences were found for reliable improvement and in depression onset. Further significant effects in favor of the intervention group were found for stress (d = 0.34), anxiety (d = 0.30), somatic symptoms (d = 0.39), burnout risk (d = 0.24-0.40) and quality of life (d = 0.28). DISCUSSION:Limiting, we did not apply an upper cutoff score for depressive symptom severity or controlled for previous MDD episodes, leaving open whether the coaching was recurrence/relapse prevention or early treatment. Nevertheless, personalized telephone coaching can effectively improve mental health in farmers. It could play an important role in intervening at an early stage of mental health problems and reducing disease burden related to MDD. TRIAL REGISTRATION NUMBER AND TRIAL REGISTER:German Clinical Trial Registration: DRKS00015655.