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How 2 deal with PCOS

How 2 deal with PCOS - H2deal-study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56665
Enrollment
222
Registered
2024-03-29
Start date
2024-11-11
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome (PCOS)

Interventions

The online program consists of 5 modules and lasts for 3 months. In the online&nbsp
program, participants are given more information about PCOS, mood, depression&nbsp
and anxiety and perform exercises to cope with PCOS symptoms. There are also&nbsp
homework assignments associated with each module.&nbsp
Every 2 weeks there is an appointment with a psychologist to discuss how things&nbsp
are going. The group with extra group sessions have an online session every 2&nbsp
weeks through the Teams program with other women with PCOS.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: women with a confirmed diagnosis of PCOS based on the Rotterdam criteria, body  Mass Index (BMI) >=18.5*kg/m2, aged above 18 years.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure of this study (depression and anxiety) will be measured with the Hospital Anxiety and Depression Scale (HADS).

Secondary

MeasureTime frame
Secondary outcome measures are quality of life (QoL) measured with the validated Dutch version of the PCOSQOL. Body image with the BCS, Coping strategies will be measured with the Coping Inventory for Stressful Situations (CISS-21) and sleep quality with the Promis short form 4a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)