NCT05679362

Brief Summary

Primary Objective:

  1. 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. 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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

December 16, 2022

Last Update Submit

April 26, 2024

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesDepression, AnxietySelf Esteem

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • QoL

    at start, after 3 and 6 months

  • Coping

    at start, after 3 and 6 months

Study Arms (3)

immediate individual treatment (A)

EXPERIMENTAL

5 online individual sessions

Behavioral: online brief CBT intervention

immediate group treatment (B)

EXPERIMENTAL

5 online group sessions with other women with PCOS

Behavioral: online brief CBT intervention

care as usual (cau)

NO INTERVENTION

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

Interventions

online brief CBT interventionBEHAVIORAL

Cognitive behavioral therapy

immediate group treatment (B)immediate individual treatment (A)

Eligibility Criteria

Age17 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGender identity
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesBehavioral SymptomsBehaviorMental Disorders

Central Study Contacts

Joop Laven, Prof

CONTACT

031-107033760j.laven@erasmusmc.nl

Wendy van Dorp, phd

CONTACT

+31107033760w.vandorp@erasmusmc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 16, 2022

First Posted

January 11, 2023

Study Start

June 1, 2024

Primary Completion

September 3, 2025

Study Completion

December 1, 2025

Last Updated

April 29, 2024

Record last verified: 2024-04

Locations

NL(1)