Mechanisms of change in digital cognitive behavioral therapy for depression in patients with chronic back pain: A mediation analysis of a multicenter randomized clinical trial.

BACKGROUND: While there is evolving knowledge on change processes of digital cognitive behavioral therapy (CBT) in the treatment of depression, little is known about how these interventions produce therapeutic change in the comorbid constellation of chronic back pain (CBP). Here, we examined whether the effects of a digital intervention to treat depression in patients with CBP are mediated by three pain-related variables (i.e., pain self-efficacy, pain-related disability, pain intensity). METHODS: This study is a secondary analysis of a randomized clinical trial conducted in routine care at 82 orthopedic clinics across Germany. In total, 209 adults with CBP and diagnosed depression (SCID interview) were randomly assigned to the intervention (n = 104) or treatment-as-usual (n = 105). Cross-lagged mediation models were estimated to investigate longitudinal mediation effects of putative mediators with depression symptom severity (PHQ-9) as primary outcome at post-treatment. RESULTS: Longitudinal mediation effects were observed for pain self-efficacy (ß = -0.094, 95%-CI [-0.174, -0.014], p = 0.021) and pain-related disability (ß = -0.068, 95%-CI [-0.130, -0.001], p = 0.047). Furthermore, the hypothesized direction of the mediation effects was supported, reversed causation did not occur. Pain intensity did not reveal a mediation effect. CONCLUSIONS: The results suggest a relevant role of pain self-efficacy and pain-related disability as change processes in the treatment of depression for patients with CBP in routine care. However, further research is needed to disclose potential reciprocal relationships of mediators, and to extend and specify our knowledge of the mechanisms of change in digital CBT for depression.

Mediators of digital depression prevention in patients with chronic back pain: Findings from a multicenter randomized clinical trial.

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

Involving patients' perspective in the development of an internet- and mobile-based CBT intervention for adolescents with chronic medical conditions: Findings from a qualitative study.

OBJECTIVE: A user-centered approach is critical for increasing the adherence to and effectiveness of an internet- and mobile-based intervention program. Therefore, potential future intervention users were involved in the development of an internet- and mobile-based cognitive behavioral therapy program (iCBT) for adolescents and young adults (AYA) with chronic medical conditions and comorbid symptoms of anxiety or depression. We aimed to identify challenges and coping strategies of the intended target group, as well as their needs and preferred intervention characteristics for an iCBT program. METHODS: Twenty AYA (aged 14-20, 60% females) with either type 1 diabetes (55%), juvenile idiopathic arthritis (25%) or cystic fibrosis (20%) were interviewed in condition-specific focus groups (4-11 participants per group) either via videoconferencing or face-to-face. Transcript verbatim data was analyzed using content analysis. RESULTS: Frequently reported disease-specific burdens were among others fear of disease progression, non-acceptance of disease and stressful incidents related to and aversions against medical therapy. Most frequently reported coping strategies included, seeking social support and accepting the disease. Recommendations for the content of an iCBT for comorbid symptoms of anxiety and depression comprised: dealing with disease-related fears and getting advice on health-promoting lifestyles. iCBT characteristics considered preferable by participants were: providing individual feedback by a real-person; implementation of a feature to monitor treatment progress; youthful and varied content presentation; time per session not exceeding 1 h; non-involvement of parents. A mobile-based reminder feature was considered useful, and individual tailoring and self-determination of iCBT content was considered desirable. CONCLUSIONS: The findings highlight important patient perspectives and age-specific recommendations which can help design more optimal iCBT interventions for AYA with chronic medical conditions.

Effectiveness and cost-effectiveness of guided Internet- and mobile-based CBT for adolescents and young adults with chronic somatic conditions and comorbid depression and anxiety symptoms (youthCOACHCD): study protocol for a multicentre randomized controlled trial.

BACKGROUND: Adolescents and young adults (AYA) with chronic somatic conditions have an increased risk of comorbid depression and anxiety symptoms. Internet- and mobile-based cognitive behavioural therapy (iCBT) might be one possibility to extend the access to evidence-based treatments. Studies suggest that guided iCBT can reduce anxiety and depression symptoms in AYA. However, little is known about the effectiveness of iCBT for AYA with chronic somatic conditions and comorbid symptoms of anxiety and/or depression in routine care. Evidence on the (cost-)effectiveness of iCBT is essential for its implementation in health care. OBJECTIVES AND METHODS: This multicentre two-armed randomized controlled trial (RCT) aims to evaluate the (cost-) effectiveness of guided iCBT (youthCOACHCD) in addition to treatment as usual (TAU) compared to enhanced treatment as usual (TAU+) in AYA aged 12-21 years with one of three chronic somatic conditions (type 1 diabetes, cystic fibrosis, or juvenile idiopathic arthritis). AYA with one of the chronic somatic conditions and elevated symptoms of anxiety or depression (Patient Health Questionnaire [PHQ-9] and/or Generalized Anxiety Disorder [GAD-7] Screener score ≥ 7) will be eligible for inclusion. We will recruit 212 patients (2 × n = 106) in routine care through three German patient registries. Assessments will take place at baseline and at 6 weeks, 3 months, 6 months, and 12 months post-randomization. The primary outcome will be combined depression and anxiety symptom severity as measured with the PHQ Anxiety and Depression Scale. Secondary outcomes will include health-related quality of life, coping strategies, self-efficacy, stress-related personal growth, social support, behavioural activation, adjustment and trauma-related symptoms, automatic thoughts, intervention satisfaction, working alliance, and Internet usage. The cost-effectiveness will be determined, and potential moderators and mediators of intervention effects will be explored. DISCUSSION: iCBT might implicate novel ways to increase the access to evidence-based interventions in this specific population. The distinct focus on effectiveness and cost-effectiveness of youthCOACHCD in patients with chronic somatic conditions, as well as intervention safety, will most likely provide important new insights in the field of paediatric e-mental health. A particular strength of the present study is its implementation directly into routine collaborative health care. As such, this study will provide important insights for health care policy and stakeholders and indicate how iCBT can be integrated into existing health care systems. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00017161. Registered on 17 September 2019.