Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: Interpersonal Psychotherapy; Polycystic Ovary Syndrome
• Interventions: Behavioral: Interpersonal Psychotherapy

• Registration Number: NCT06056453
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-20
• Study First Submitted: 2022-12-07
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-14
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-20
• Last Update Submitted: 2023-09-20
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPT	Interpersonal Psychotherapy	Participate in IPT 6-week intervention group.

Primary Outcome Measures

Name	Time	Method
Center for Epidemiologic Studies-Depression Scale	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 Outcome Measures

Name	Time	Method
Emotional Eating Scale Adapted for Children	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment	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.
BMI	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment	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).
Insulin Resistance	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment	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).
Loss-of-Control Eating Disorder Questionnaire	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment	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.
Dysglycemia	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment	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).
Reward Based Eating Drive Scale	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment	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.
Dyslipidemia	Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment	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).

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States