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Clinical Trials/NCT06056453
NCT06056453
Completed
Not Applicable

Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome

University of Colorado, Denver1 site in 1 country30 target enrollmentSeptember 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Interpersonal Psychotherapy
Sponsor
University of Colorado, Denver
Enrollment
30
Locations
1
Primary Endpoint
Center for Epidemiologic Studies-Depression Scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2021
End Date
July 14, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Center for Epidemiologic Studies-Depression Scale

Time Frame: 6-Month Follow-Up Assessment

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.

Secondary Outcomes

  • Emotional Eating Scale Adapted for Children(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)
  • Loss-of-Control Eating Disorder Questionnaire(Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment)
  • Dysglycemia(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)
  • Dyslipidemia(Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment)

Study Sites (1)

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