Clinical trial NCT05679362: Online Brief CBT Intervention for Women With PCOS
Official title: How 2 Deal With PCOS: a Randomized Online Intervention for Women With PCOS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Depression, Anxiety
Self Esteem
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: The Waterloo Foundation
First posted: 2023-01-11
Enrollment: 222
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Depression
timeFrame: at start, after 3 and 6 months
measure: Anxiety
timeFrame: at start, after 3 and 6 months
Secondary outcomes:
measure: QoL
timeFrame: at start, after 3 and 6 months
measure: Coping
timeFrame: at start, after 3 and 6 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
References: