Skip to main content
OpenTrials
Completed

NCT Number: NCT06056453

Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Interpersonal Psychotherapy Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

12 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interpersonal psychotherapy

Behavioral

IPT group-virtual

Primary outcomes

  1. Center for Epidemiologic Studies-Depression Scale

    Time frame: Baseline

    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.

  2. Center for Epidemiologic Studies-Depression Scale

    Time frame: 6-Week 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.

  3. 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

  1. Emotional Eating Scale Adapted for Children

    Time frame: 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.

  2. Loss-of-Control Eating Disorder Questionnaire

    Time frame: 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.

  3. Reward Based Eating Drive Scale

    Time frame: 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.

  4. BMI

    Time frame: 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).

  5. Insulin Resistance

    Time frame: 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).

  6. Dysglycemia

    Time frame: 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).

  7. Dyslipidemia

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • American Psychological Association (APA)

Registry information

Acronym: IPAP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.