Online Brief CBT Intervention for Women With PCOS (How2deal)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression, Anxiety; Self Esteem; PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Intervention / Treatment: Behavioral: online brief CBT intervention

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 Type: Interventional
• Enrollment (Estimated): 222
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joop Laven, Prof; Phone Number: 031-107033760; Email: j.laven@erasmusmc.nl
• Study Contact Backup: Name: Wendy van Dorp, phd; Phone Number: +31107033760; Email: w.vandorp@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Erasmus MC
    • Contact: Geranne Jiskoot, phd; Email: L.jiskoot@erasmusmc.nl
    • Contact: Yvonne Louwers, phd; Email: y.louwers@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immediate individual treatment (A); 5 online individual sessions	Behavioral: online brief CBT intervention; Cognitive behavioral therapy
Experimental: immediate group treatment (B); 5 online group sessions with other women with PCOS	Behavioral: online brief CBT intervention; Cognitive behavioral therapy
No Intervention: care as usual (cau); The CAU group receives standard treatment for depressive symptoms from their general practitioner (GP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Waterloo Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 3, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome
• Other Study ID Numbers: How2deal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No