Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome

NCT ID: NCT06056453

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2023-07-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main purpose of this study is to find out whether taking part in a group-based interpersonal psychotherapy (IPT) program designed to improve mood and lessen stress in girls with PCOS will improve depression, unhealthy eating behaviors, weight, and insulin resistance.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Interpersonal Psychotherapy Polycystic Ovary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IPT

Participate in IPT 6-week intervention group.

Group Type EXPERIMENTAL

Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

IPT group-virtual

UC

Continue with usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interpersonal Psychotherapy

IPT group-virtual

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosed with PCOS duration \> 3 months
* 12-17 years old
* BMI \> 75th percentile
* CESD \> 16

Exclusion Criteria

* Weekly or bi-weekly therapy with licensed behavioral health provider
* Inability to speak, read, or write in English (teen)
* Major medical conditions
* HbA1c \> 7.0%
* Hormonal contraception \< 3 months
* Metformin \< 3 months
* Antidepressants/psychotropic medications \< 4 weeks
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Psychological Association (APA)

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lauren Gulley, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-3033

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Cooking and Eating Study
NCT01079845 TERMINATED NA