Online Brief CBT Intervention for Women With PCOS (NCT05679362) | Clinical Trial Compass
UnknownNot Applicable
Online Brief CBT Intervention for Women With PCOS
Netherlands222 participantsStarted 2024-06-01
Plain-language 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.
Who can participate
Age range
17 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* women with a confirmed diagnosis of PCOS based on the Rotterdam criteria
* body Mass Index (BMI) ≥18.5 kg/m2
* aged 18-55 years.
* mild depressive symptoms or anxiety scores based on the Hospital Anxiety and Depression Scale (HADS) and/or a negative body image based on the Body Cathexis Scale (BCS).
Exclusion Criteria:
* pregnancy
* current treatment for clinical depression, anxiety disorders or eating disorders
* suicidality (indicated by a score \>2 on the Beck Depression Inventory II suicide item)
* having an endocrine disease (diabetes mellitus, thyroid function disorders, Cushing's disease, adrenal tumors, and congenital adrenal hyperplasia)
* inability to speak, read or write Dutch.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.