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Clinical Trial Summary

The aim of this randomized controlled trial is to test the effectiveness of an online brief standardized CBT intervention in women with PCOS. 1. To study if an online brief CBT intervention is effective for anxiety and depression compared to control (waiting-list) in patients with PCOS 2. To study if an online group-based brief CBT intervention is more effective for anxiety and depression compared to online individual brief CBT in patients with PCOS. 3. To determine if an online brief CBT intervention is effective for improvements in QoL, coping strategies, body image, and eating disorder symptoms compared to control (waiting-list) in patients with PCOS


Clinical Trial Description

The online brief CBT intervention is designed to address three problems that have often been reported in women with PCOS. Therefore, the program contains three themes: Psychoeducation about PCOS; traditional CBT and problem-solving therapy. The brief CBT intervention consists of 5 online individual CBT sessions (60 minutes per session) or 5 group CBT sessions (60 minutes per session). Participants are randomized into one of three groups: 1. immediate individual treatment (A) 2. immediate group treatment (B) and 3. a wait-list-control group. The immediately treatment A and B begins for a total duration of 3 months: Week 1: Session 1 +homework assignments Week 3: Session 2 +homework assignments Week 5: Session 3 +homework assignments Week 8: Session 4 +homework assignments Week 12: Session 5 +homework assignments The wait-list control group receives no treatment for the first three months, at which point they will cross over to one of the intervention arms (individual treatment A or group treatment B) and start with the intervention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05679362
Study type Interventional
Source Erasmus Medical Center
Contact Joop Laven, Prof
Phone 031-107033760
Email j.laven@erasmusmc.nl
Status Not yet recruiting
Phase N/A
Start date June 1, 2024
Completion date December 1, 2025

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