Online Brief CBT Intervention for Women With PCOS

Status Not yet recruiting

Clinical Trial Summary

Primary Objective: -To study if an online individual brief CBT (group A) intervention is effective for psychological distress (anxiety and depression) compared to a CAU group in patients with PCOS at 3 and 6 months relative to baseline. Secondary Objective(s): 1. To study if an online group based brief CBT (group B) is more effective for anxiety and depression compared to CAU in patients with PCOS at 3 and 6 months relative to baseline. 2. To determine if an online individual brief CBT (group A) is effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline. 3. To determine if an group based brief CBT (group B) is more effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline. 4. If A and B are effective compared to CAU, we will compare online individual brief CBT (group A) to online group based brief CBT (group B) for anxiety and depression, QoL, coping strategies, body image and sleep quality compared to in patients with PCOS at 3 and 6 months relative to baseline.

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. Participants are randomized into one of three groups: 1. individual treatment (A) 2. group treatment (B) 3. care as usual (CAU) Treatment A and B include 5 sessions divided over a period 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 CAU group receives standard treatment for depressive symptoms from their general practitioner (GP). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Online Brief CBT Intervention for Women With PCOS — How2deal

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms