drugset / Trial / NCT05528224

Effect of SC-ICBT for Adults With OCD:A Three-Arm Randomized Controlled Trial

NCT05528224 ↗

Terminated 46 enrolled Shanghai Mental Health Center
RandomizedParallel-groupSingle-blindTreatment

Summary

The goal of this clinical trial is to learn about the efficacy and cost-effectiveness of stepped-care Internet-based cognitive behavioral therapy (SC-ICBT) compared with Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (treatment as usual, TAU) in adults with obsessive-compulsive disorder (OCD) in China. The main questions it aims to answer are: question 1: Whether the efficacy of SC-ICBT is noninferior to CBGT and TAU for OCD? question 2: Whether SC-ICBT is more cost-effective than CBGT and TAU for OCD? Participants will receive treatment (SC-ICBT or CBGT or TAU) for 6 weeks. Prior to the main study, we conduct a non-randomized pilot study to explore the efficacy and cost-effectiveness of SC-ICBT related to CBGT for adults with OCD in China.

Timeline

Start
2022-09-01
Primary completion
2023-08-30
Completion
2024-03-31

Outcome

Outcome not reported

Stopped: “Main trial terminated after pilot trial: full randomization proved infeasible for nonlocal participants; baseline symptom-based allocation added confounding variable; comparison with CBGT alone was deemed sufficient to assess SC-ICBT effectiveness”

Drugs

EvaluationDrugModalityDoseRoute
Background Citalopram Small molecule — —
Background Escitalopram Small molecule — —
Background Fluoxetine Small molecule — —
Background Fluvoxamine Unknown — —
Background Paroxetine Small molecule — —
Background Sertraline Small molecule — —