Depression, Anxiety, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Self Esteem
Conditions
Brief 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.
Detailed description
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).
Interventions
BEHAVIORALonline brief CBT intervention
Cognitive behavioral therapy
Sponsors
The Waterloo Foundation
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | at start, after 3 and 6 months | 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. |
| Anxiety | at start, after 3 and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coping | at start, after 3 and 6 months | 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. |
| QoL | at start, after 3 and 6 months | 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. |
Countries
Netherlands
Contacts
Primary ContactJoop Laven, Prof
Backup ContactWendy van Dorp, phd
Outcome results
None listed