Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
222 participants
INTERVENTIONAL
2024-06-01
2025-12-01
Brief Summary
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-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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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immediate individual treatment (A)
5 online individual sessions
online brief CBT intervention
Cognitive behavioral therapy
immediate group treatment (B)
5 online group sessions with other women with PCOS
online brief CBT intervention
Cognitive behavioral therapy
care as usual (cau)
The CAU group receives standard treatment for depressive symptoms from their general practitioner (GP).
No interventions assigned to this group
Interventions
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online brief CBT intervention
Cognitive behavioral therapy
Eligibility Criteria
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Inclusion 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
* 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.
17 Years
55 Years
FEMALE
No
Sponsors
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The Waterloo Foundation
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Geranne Jiskoot
Principal investigator
Locations
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Erasmus MC
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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How2deal
Identifier Type: -
Identifier Source: org_study_id
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