Body dysmorphic disorder (BDD) is a prevalent and impairing mental disorder that typically onsets in adolescence. Cognitive-behavior therapy (CBT) may be effective for adolescent BDD, although the supporting evidence is currently limited. CBT for BDD is a highly specialized treatment, creating a considerable gap in access to care for young people. Therapist-guided Internet-delivered CBT (ICBT) may help bridge this gap. The primary aim of this study is to determine the efficacy of a therapist-guided ICBT program for children and adolescents with BDD versus an active comparator. Secondary aims are to examine the 6-month durability of the treatment effects and to evaluate its relative cost-effectiveness from multiple perspectives. This is a 3-site superiority randomized controlled trial including 154 young people (12–17 years) with BDD recruited throughout Sweden. Participants are randomized 1:1 to 12 weekly modules of either therapist-supported ICBT primarily based on exposure with response prevention or an active comparator consisting of therapist-supported Internet-delivered relaxation training. Data will be collected at baseline, mid-treatment, post-treatment, and 1 month (primary endpoint), 3 months, and 6 months post-treatment. The primary outcome is BDD symptom severity measured with the Yale-Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version. All study personnel who can be blinded to study aims/hypotheses and group allocation will be blinded. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blinded to study aims/hypotheses and group allocation at all assessment points. Analyses will be conducted according to the intention-to-treat principle and will follow a pre-specified statistical and health economic analysis plan. Participant recruitment started on 22 February 2024 and is currently ongoing. Data analysis for the primary aim will commence after the last participant reaches the primary endpoint. ClinicalTrials.gov NCT06262412. Registered on 16 February 2024, https://clinicaltrials.gov/study/NCT06262412.
L. Fernández de la Cruz, Anita Birovecz, Per Andrén et al.· Trials· 0 citations
Abstract Background Adolescent depression is a major public health concern with limited access to effective treatments. Behavioural activation (BA) is a suitable intervention for digital delivery, but definitive adolescent trials are scarce. Objective To evaluate whether therapist-guided and self-guided internet-based BA (I-BA) are more efficacious and cost-effective than treatment as usual (TAU) for adolescents with mild to moderate major depressive disorder (MDD). Methods Single-blinded, parallel-group randomised controlled trial with economic evaluation. A total of 219 adolescents (13–17 years) with mild-moderate MDD were randomised (1:1:1) to 10 weeks of therapist-guided I-BA, self-guided I-BA or TAU. Both I-BA interventions included adolescent and parent modules. Primary outcome: change in depression severity (Children’s Depression Rating Scale-Revised, CDRS-R, range 17–113) from baseline to 3-month follow-up (primary endpoint), assessed by blinded evaluators. Analyses included all randomised participants, with statisticians blinded to allocation. A health economic evaluation was performed at the primary endpoint. Findings Baseline CDRS-R indicated clinically significant depression (mean 57.1, threshold ≥40). Retention at the primary endpoint was 82.6%. Mean reductions were 17.0 (therapist-guided I-BA), 16.0 (self-guided I-BA) and 11.6 (TAU), bringing both I-BA groups below the clinical cut-off. Therapist-guided I-BA showed greater reductions than TAU (estimated mean difference −4.68; 95% CI −0.05 to −9.30; p=0.048, d=−0.47; 95% CI 0.00 to −0.93), while self-guided I-BA was not statistically superior (estimated mean difference −3.44; 95% CI −8.05 to 1.17, p=0.14, d=−0.37; 95% CI −0.86 to 0.12). The predefined six-point clinical important difference was not met. Results were sensitive to modelling: significance disappeared with random slopes but effect estimates were similar; baseline-adjusted analyses favoured both I-BA arms. Both I-BA options had lower costs than TAU (p=0.03, p<0.001), with self-guided I-BA being the most economical. Conclusions Therapist-guided I-BA reduced depressive symptoms at lower cost than TAU, but clinical importance and robustness are uncertain. Self-guided I-BA showed no clear superiority but was cost-efficient. Clinical implications Therapist-guided I-BA may increase access to evidence-based care for adolescents with MDD, though findings require cautious interpretation. Self-guided I-BA may be useful where therapist access is limited, but more research is needed.
Rebecca Andersson, J. Åhlén, F. Lenhard et al.· BMJ mental health· 0 citations
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