NCT05679362

Online Brief CBT Intervention for Women With PCOS

How 2 Deal With PCOS: a Randomized Online Intervention for Women With PCOS

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: Female
• Age: 17 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Depression, Anxiety
• Self Esteem

Interventions

Type	Name	Description
BEHAVIORAL	online brief CBT intervention	Cognitive behavioral therapy

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-09-03
• Completion: 2025-12-01
• First posted: 2023-01-11
• Last updated: 2024-04-29

Locations

1 site across 1 country: Netherlands