NCT06056453

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 20, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

December 7, 2022

Last Update Submit

September 20, 2023

Conditions

Interpersonal PsychotherapyPolycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

  • Center for Epidemiologic Studies-Depression Scale

    Depression symptoms will be assessed by the Center for Epidemiologic Studies-Depression Scale. Scores range from 1 to 4. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

    Baseline

  • Center for Epidemiologic Studies-Depression Scale

    Depression symptoms will be assessed by the Center for Epidemiologic Studies-Depression Scale. Scores range from 1 to 4. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

    6-Week Follow-Up Assessment

  • Center for Epidemiologic Studies-Depression Scale

    Depression symptoms will be assessed by the Center for Epidemiologic Studies-Depression Scale. Scores range from 1 to 4. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

    6-Month Follow-Up Assessment

Secondary Outcomes (7)

  • Emotional Eating Scale Adapted for Children

    Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment

  • Loss-of-Control Eating Disorder Questionnaire

    Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment

  • Reward Based Eating Drive Scale

    Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment

  • BMI

    Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment

  • Insulin Resistance

    Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment

  • +2 more secondary outcomes

Study Arms (2)

IPT

EXPERIMENTAL

Participate in IPT 6-week intervention group.

Behavioral: Interpersonal Psychotherapy

UC

NO INTERVENTION

Continue with usual care.

Interventions

Interpersonal PsychotherapyBEHAVIORAL

IPT group-virtual

IPT

Eligibility Criteria

Age12 Years - 17 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with PCOS duration \> 3 months
  • years old
  • BMI \> 75th percentile
  • CESD \> 16

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lauren Gulley, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

September 28, 2023

Study Start

September 20, 2021

Primary Completion

July 14, 2023

Study Completion

July 14, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

US(1)