Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome (IPAP)

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Interpersonal Psychotherapy
• Intervention / Treatment: Behavioral: Interpersonal Psychotherapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IPT; Participate in IPT 6-week intervention group.	Behavioral: Interpersonal Psychotherapy; IPT group-virtual
No Intervention: UC; Continue with usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Eating Scale Adapted for Children	Disordered eating will be assessed by the Emotional Eating Scale Adapted for Children. The scale has been adapted for children and assesses eating in response to negative affect, such as feeling sad or irritated. The scale ranges from "I have no desire to eat" to "I have a very strong desire to eat" and averages how many days a week the participant eats based on that feeling.	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Loss-of-Control Eating Disorder Questionnaire	Loss-of-control eating will be assessed via the 19-item Loss-of-Control Eating Disorder Questionnaire (LOC-ED-Q), which shows sound psychometric properties in adolescents using Yes/No.	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Reward Based Eating Drive Scale	Reward based eating will be assessed by the Reward Based Eating Drive Scale. This is a self-report questionnaire which assesses reward-based eating that shows sound psychometric properties. The total score is summed at the end; a higher total is indicative of reward-based eating.	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
BMI	Fasting BMI (kg/m2) will be derived from measured height in triplicate by stadiometer and measured fasting weight by calibrated digital scale. BMI z-score and BMI %ile will be computed to determine eligibility (BMI ≥75th percentile).	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Insulin Resistance	Blood will be sampled via a venipuncture procedure following a 10-hour overnight fast to measure fasting insulin. Insulin resistance will be estimated from fasting insulin and glucose with the homeostatic model assessment of insulin resistance (HOMA-IR).	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Dysglycemia	Blood will be sampled via a venipuncture procedure following a 10-hour overnight fast to measure fasting insulin. Insulin resistance will be estimated from fasting insulin and glucose with the homeostatic model assessment of insulin resistance (HOMA-IR).	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Dyslipidemia	Blood will be sampled via a venipuncture procedure following a 10-hour overnight fast to measure dyslipidemia. Insulin resistance will be estimated from fasting insulin and glucose with the homeostatic model assessment of insulin resistance (HOMA-IR).	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: American Psychological Association (APA)
• Investigators: Principal Investigator: Lauren Gulley, PhD, Colorado State University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: 20-3033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No