Online Brief CBT Intervention for Women With PCOS

Not Applicable

Not yet recruiting

• Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; Self Esteem; Depression, Anxiety
• Interventions: Behavioral: online brief CBT intervention

• Registration Number: NCT05679362
• Lead Sponsor: Erasmus Medical Center

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).

Study Timeline

• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2022-12-23
• Study First Posted: 2023-01-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Study Start: 2024-06-01
• Primary Completion: 2025-09-03
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 222

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
immediate individual treatment (A)	online brief CBT intervention	5 online individual sessions
immediate group treatment (B)	online brief CBT intervention	5 online group sessions with other women with PCOS

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands