Clinical trial · Interventional
Online Brief CBT Intervention for Women With PCOS
How 2 Deal With PCOS: a Randomized Online Intervention for Women With PCOS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression, Anxiety | — | UNRESOLVED | — |
| PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries | — | UNRESOLVED | — |
| Self Esteem | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| online brief CBT intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- immediate individual treatment (A)
- description
- 5 online individual sessions
- interventionNames
- Behavioral: online brief CBT intervention
- type
- EXPERIMENTAL
- label
- immediate group treatment (B)
- description
- 5 online group sessions with other women with PCOS
- interventionNames
- Behavioral: online brief CBT intervention
- type
- NO_INTERVENTION
- label
- care as usual (cau)
- description
- The CAU group receives standard treatment for depressive symptoms from their general practitioner (GP).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 17 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (0)
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