Online Brief CBT Intervention for Women With PCOS

Study Overview
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Brief Summary
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The aim of this randomized controlled trial is to test the effectiveness of an online brief standardized CBT intervention in women with PCOS. To study if an online brief CBT intervention is effective for anxiety and depression compared to control (waiting-list) in patients with PCOS 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. 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

Detailed Description
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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. The brief CBT intervention consists of 5 online individual CBT sessions (60 minutes per session) or 5 group CBT sessions (60 minutes per session). Participants are randomized into one of three groups: immediate individual treatment (A) immediate group treatment (B) and a wait-list-control group. The immediately treatment A and B begins for a total duration 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 wait-list control group receives no treatment for the first three months, at which point they will cross over to one of the intervention arms (individual treatment A or group treatment B) and start with the intervention.

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

Conditions
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PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Depression, Anxiety, Self Esteem

Intervention / Treatment
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* Behavioral: online brief CBT intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized parallel waiting-list intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate individual treatment (A)<br>5 online individual sessions | Behavioral: online brief CBT intervention<br>* Cognitive behavioral therapy<br>|
| Experimental: immediate group treatment (B)<br>5 online group sessions with other women with PCOS | Behavioral: online brief CBT intervention<br>* Cognitive behavioral therapy<br>|
| No Intervention: wait-list-control group<br>The wait-list control group receives no treatment for the first three months, at which point they will cross over to one of the intervention arms (individual treatment A or group treatment B) and start with the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |