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NOT YET RECRUITING
NCT05679362
NA

Online Brief CBT Intervention for Women With PCOS

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

17 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2024-06-01

Completion Date

2025-12-01

Last Updated

2024-04-29

Healthy Volunteers

No

Interventions

BEHAVIORAL

online brief CBT intervention

Cognitive behavioral therapy

Locations (1)

Erasmus MC

Rotterdam, Netherlands