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How 2 Deal With PCOS: a Randomized Online Intervention for Women With PCOS
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.
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).
Age
17 - 55 years
Sex
FEMALE
Healthy Volunteers
No
Erasmus MC
Rotterdam, Netherlands
Start Date
June 1, 2024
Primary Completion Date
September 3, 2025
Completion Date
December 1, 2025
Last Updated
April 29, 2024
222
ESTIMATED participants
online brief CBT intervention
BEHAVIORAL
Lead Sponsor
Erasmus Medical Center
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05837104