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| Name | Class |
|---|---|
| The Waterloo Foundation | OTHER |
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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):
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate individual treatment (A) | Experimental | 5 online individual sessions |
|
| immediate group treatment (B) | Experimental | 5 online group sessions with other women with PCOS |
|
| care as usual (cau) | No Intervention | The CAU group receives standard treatment for depressive symptoms from their general practitioner (GP). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| online brief CBT intervention | Behavioral | Cognitive behavioral therapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Gender identity
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joop Laven, Prof | Contact | 031-107033760 | j.laven@erasmusmc.nl | |
| Wendy van Dorp, phd | Contact | +31107033760 | w.vandorp@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | Netherlands |
|
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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Randomized controlled trial
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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 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |