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Online Brief CBT Intervention for Women With PCOS (How2deal)

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
online brief CBT intervention
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Eligibility Criteria

17 Years - 55 Years (Child, Adult)FemaleDoes not accept 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.

Sites / Locations

  • Erasmus MC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

immediate individual treatment (A)

immediate group treatment (B)

wait-list-control group

Arm Description

5 online individual sessions

5 online group sessions with other women with PCOS

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 16, 2022
Last Updated
February 17, 2023
Sponsor
Erasmus Medical Center
Collaborators
Waterloo Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05679362
Brief Title
Online Brief CBT Intervention for Women With PCOS
Acronym
How2deal
Official Title
How 2 Deal With PCOS: a Randomized Online Intervention for Women With PCOS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
June 3, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Waterloo Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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. To study if an online brief CBT intervention is effective for anxiety and depression compared to control (waiting-list) in patients with PCOS 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. 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
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: immediate individual treatment (A) immediate group treatment (B) and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Depression, Anxiety, Self Esteem

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized parallel waiting-list intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
immediate individual treatment (A)
Arm Type
Experimental
Arm Description
5 online individual sessions
Arm Title
immediate group treatment (B)
Arm Type
Experimental
Arm Description
5 online group sessions with other women with PCOS
Arm Title
wait-list-control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
online brief CBT intervention
Intervention Description
Cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Depression
Description
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.
Time Frame
at start, after 3 and 6 months
Title
Anxiety
Description
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.
Time Frame
at start, after 3 and 6 months
Secondary Outcome Measure Information:
Title
QoL
Description
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.
Time Frame
at start, after 3 and 6 months
Title
Coping
Description
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.
Time Frame
at start, after 3 and 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gender identity
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joop Laven, Prof
Phone
031-107033760
Email
j.laven@erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy van Dorp, phd
Phone
+31107033760
Email
w.vandorp@erasmusmc.nl
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geranne Jiskoot, phd
Email
L.jiskoot@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Yvonne Louwers, phd
Email
y.louwers@erasmusmc.nl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Online Brief CBT Intervention for Women With PCOS

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