How2deal: Online Brief CBT Intervention for Women With PCOS

• Sponsor: Erasmus Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05679362
• Collaborator: Waterloo Foundation (Other)
• Enrollment: 158
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 22.5
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

The aim of this randomized controlled trial is to test the effectiveness of an online brief standardized CBT intervention in women with PCOS.

1. To study if an online brief CBT intervention is effective for anxiety and depression compared to control (waiting-list) in patients with PCOS

2. To study if an online group-based brief CBT intervention is more effective for anxiety and depression compared to online individual brief CBT in patients with PCOS.

3. To determine if an online brief CBT intervention is effective for improvements in QoL, coping strategies, body image, and eating disorder symptoms compared to control (waiting-list) in patients with PCOS

Condition or Disease	Intervention/Treatment	Phase
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; Depression, Anxiety; Self Esteem	Behavioral: online brief CBT intervention	N/A

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. The brief CBT intervention consists of 5 online individual CBT sessions (60 minutes per session) or 5 group CBT sessions (60 minutes per session).

Participants are randomized into one of three groups:

1. immediate individual treatment (A)

2. immediate group treatment (B) and

3. a wait-list-control group.

The immediately treatment A and B begins for a total duration 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 wait-list control group receives no treatment for the first three months, at which point they will cross over to one of the intervention arms (individual treatment A or group treatment B) and start with the intervention.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized parallel waiting-list interventionRandomized parallel waiting-list intervention
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: How 2 Deal With PCOS: a Randomized Online Intervention for Women With PCOS
• Anticipated Study Start Date: Jan 16, 2023
• Anticipated Primary Completion Date: Jun 3, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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: wait-list-control group The wait-list control group receives no treatment for the first three months, at which point they will cross over to one of the intervention arms (individual treatment A or group treatment B) and start with the intervention.

Outcome Measures

Primary Outcome Measures

1. Depression [at start, after 3 and 6 months]

   Changes in depression scores as assessed by the Hospital anxiety and depression scale (HADS)

2. Anxiety [at start, after 3 and 6 months]

   Changes in anxiety scores as assessed by the Hospital anxiety and depression scale (HADS)

Secondary Outcome Measures

1. QoL [at start, after 3 and 6 months]

   The Polycystic Ovary Syndrome Quality of Life scale (PCOSQOL)

2. Coping [at start, after 3 and 6 months]

   Coping Inventory for stressful situation (CISS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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. Women are also included if they have 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:

pregnant, 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) and inability to speak, read or write Dutch.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasmus MC	Rotterdam		Netherlands

Sponsors and Collaborators

• Erasmus Medical Center
• Waterloo Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Geranne Jiskoot, Principal investigator, Erasmus Medical Center
• ClinicalTrials.gov Identifier: NCT05679362
• Other Study ID Numbers: How2deal
• First Posted: Jan 11, 2023
• Last Update Posted: Jan 11, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome

Study Results

No Results Posted as of Jan 11, 2023