Objective: To assess benefits and harms of cognitive-behavioral therapy (CBT) versus no intervention or versus other interventions for pediatric obsessive-compulsive disorder (OCD). Method: We searched for randomized clinical trials of CBT for pediatric OCD. Primary outcomes were OCD severity, serious adverse events, and level of functioning. Secondary outcomes were quality of life and adverse events. Remission from OCD was included as an exploratory outcome. We assessed risk of bias and evaluated the certainty of the evidence with the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results: Nine trials (N ¼ 645) were included comparing CBT with no intervention and 3 trials (N ¼ 146) comparing CBT with selective serotonin reuptake inhibitors (SSRIs). Compared with no intervention, CBT decreased OCD severity (mean difference [MD] ¼ À8.51, 95% CI ¼ À10.84 to À6.18, p < .00001, low certainty), improved level of functioning (patient-rated: standardized MD [SMD] ¼ À0.90, 95% CI ¼ À1.19 to À0.62, p < .00001, very low certainty; parent-rated: SMD ¼ À0.68, 95% CI ¼ À1.12 to À0.23, p ¼ .003, very low certainty), had similar proportions of participants with adverse events (risk ratio ¼ 1.06, 95% CI ¼ 0.93À1.22, p ¼ .39, GRADE: low certainty), and was associated with reduced risk of still having OCD (risk ratio ¼ 0.50, 95% CI ¼ 0.37À0.67, p < .00001, very low certainty). We had insufficient data to assess the effect of CBT versus no intervention on serious adverse events and quality of life. Compared with SSRIs, CBT led to similar decreases in OCD severity (MD ¼ À0.75, 95% CI ¼ À3.79 to 2.29, p ¼ .63, GRADE: very low certainty), and was associated with similar risk of still having OCD (risk ratio ¼ 0.85, 95% CI ¼ 0.66À1.09, p ¼ .20, very low certainty). We had insufficient data to assess the effect of CBT versus SSRIs on serious adverse events, level of functioning, quality of life, and adverse events. Conclusion: CBT may be more effective than no intervention and comparable to SSRIs for pediatric OCD, but we are very uncertain about the effect estimates.
Background Cognitive behavioural therapy (CBT) is the recommended first-line treatment for children and adolescents with obsessive-compulsive disorder (OCD), but evidence concerning treatment-specific benefits and harms compared with other interventions is limited. Furthermore, high risk-of-bias in most trials prevent firm conclusions regarding the efficacy of CBT. We investigate the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation and relaxation training (FPRT) in youth with OCD in a trial designed to reduce risk-of-bias. Methods This is an investigator-initiated, independently funded, single-centre, parallel group superiority randomised clinical trial (RCT). Outcome assessors, data managers, statisticians, and conclusion drawers are blinded. From child and adolescent mental health services we include patients aged 8–17 years with a primary OCD diagnosis and an entry score of ≥16 on the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). We exclude patients with comorbid illness contraindicating trial participation; intelligence quotient < 70; or treatment with CBT, PRT, antidepressant or antipsychotic medication within the last 6 months prior to trial entry. Participants are randomised 1:1 to the experimental intervention (FCBT) versus the control intervention (FPRT) each consisting of 14 75-min sessions. All therapists deliver both interventions. Follow-up assessments occur in week 4, 8 and 16 (end-of-treatment). The primary outcome is OCD symptom severity assessed with CY-BOCS at end-of-trial. Secondary outcomes are quality-of-life and adverse events. Based on sample size estimation, a minimum of 128 participants (64 in each intervention group) are included. Discussion In our trial design we aim to reduce risk-of-bias, enhance generalisability, and broaden the outcome measures by: 1) conducting an investigator-initiated, independently funded RCT; 2) blinding investigators; 3) investigating a representative sample of OCD patients; 3) using an active control intervention (FPRT) to tease apart general and specific therapy effects; 4) using equal dosing of interventions and therapist supervision in both intervention groups; 5) having therapists perform both interventions decided by randomisation; 6) rating fidelity of both interventions; 7) assessing a broad range of benefits and harms with repeated measures. The primary study limitations are the risk of missing data and the inability to blind participants and therapists to the intervention. Trial registration ClinicalTrials.gov: NCT03595098, registered July 23, 2018.
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