Online Brief CBT Intervention for Women With PCOS

Depression, Anxiety Clinical Trial

— How2deal  

Official title:

How 2 Deal With PCOS: a Randomized Online Intervention for Women With PCOS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05679362
• Other study ID #: How2deal
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Erasmus Medical Center
• Contact: Joop Laven, Prof
• Phone: 031-107033760
• Email: j.laven[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 222
• Est. completion date: December 1, 2025
• Est. primary completion date: September 3, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression, Anxiety
• Polycystic Ovary Syndrome
• Self Esteem

Intervention

Behavioral:
• online brief CBT intervention
Cognitive behavioral therapy

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Waterloo Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Coping	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