Depression, Anxiety Clinical Trial
— How2dealOfficial title:
How 2 Deal With PCOS: a Randomized Online Intervention for Women With PCOS
The aim of this randomized controlled trial is to test the effectiveness of an online brief standardized CBT intervention in women with PCOS. 1. To study if an online brief CBT intervention is effective for anxiety and depression compared to control (waiting-list) in patients with PCOS 2. To study if an online group-based brief CBT intervention is more effective for anxiety and depression compared to online individual brief CBT in patients with PCOS. 3. To determine if an online brief CBT intervention is effective for improvements in QoL, coping strategies, body image, and eating disorder symptoms compared to control (waiting-list) in patients with PCOS
Status | Not yet recruiting |
Enrollment | 158 |
Est. completion date | December 1, 2025 |
Est. primary completion date | September 3, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 17 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus MC | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center | Waterloo Foundation |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depression | Changes in depression scores as assessed by the Hospital anxiety and depression scale (HADS). HADS is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. A higher score indicates higher distress. | at start, after 3 and 6 months | |
Primary | Anxiety | Changes in anxiety scores as assessed by the Hospital anxiety and depression scale (HADS). HADS is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. A higher score indicates higher distress. | at start, after 3 and 6 months | |
Secondary | QoL | The Polycystic Ovary Syndrome Quality of Life scale (PCOSQOL). The PCOSQOL is a 35-item questionnaire with four subscales: Impact of PCOS, Infertility, Hirsutism and Mood. Lower scores represent a decreased QoL. | at start, after 3 and 6 months | |
Secondary | Coping | Coping Inventory for stressful situation (CISS). Scores for all items per scale are summed to form scale scores; higher scores indicate a greater use of that particular coping strategy. | at start, after 3 and 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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