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Trial Title:
Online Brief CBT Intervention for Women With PCOS
NCT ID:
NCT05679362
Condition:
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Depression, Anxiety
Self Esteem
Conditions: Official terms:
Polycystic Ovary Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
Randomized controlled trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
online brief CBT intervention
Description:
Cognitive behavioral therapy
Arm group label:
immediate group treatment (B)
Arm group label:
immediate individual treatment (A)
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).
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
Gender identity
Minimum age:
17 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Country:
Netherlands
Contact:
Last name:
Geranne Jiskoot, phd
Email:
L.jiskoot@erasmusmc.nl
Contact backup:
Last name:
Yvonne Louwers, phd
Email:
y.louwers@erasmusmc.nl
Start date:
June 1, 2024
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Waterloo Foundation
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05679362
