Online Brief CBT Intervention for Women With PCOS (How2deal)

Erasmus University

Status: Not yet enrolling

Conditions: Self Esteem; Depression, Anxiety; PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Treatments: Behavioral: online brief CBT intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05679362

How2deal

Details and patient eligibility

About

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.

Full 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).

Enrollment: 222 estimated patients

Sex: Female

Ages: 17 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

222 participants in 3 patient groups

immediate individual treatment (A)

Experimental group

Description:

5 online individual sessions

Treatment:

Behavioral: online brief CBT intervention

immediate group treatment (B)

Experimental group

Description:

5 online group sessions with other women with PCOS

Treatment:

Behavioral: online brief CBT intervention

care as usual (cau)

No Intervention group

Description:

The CAU group receives standard treatment for depressive symptoms from their general practitioner (GP).