Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome - Clinical Trial for Interpersonal Psychotherapy | NCT06056453

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Interpersonal Psychotherapy

About this trial

This is an interventional treatment trial for Interpersonal Psychotherapy

Eligibility Criteria

12 Years - 17 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IPT

UC

Arm Description

Participate in IPT 6-week intervention group.

Continue with usual care.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

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).

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).

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).

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).

Full Information

NCT ID

NCT06056453

First Posted

December 7, 2022

Last Updated

September 20, 2023

Sponsor

University of Colorado, Denver

Collaborators

American Psychological Association (APA)

1. Study Identification

Unique Protocol Identification Number

NCT06056453

Brief Title

Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome

Acronym

IPAP

Official Title

Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

September 20, 2021 (Actual)

Primary Completion Date

July 14, 2023 (Actual)

Study Completion Date

July 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

American Psychological Association (APA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Interpersonal Psychotherapy, Polycystic Ovary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IPT

Arm Type

Experimental

Arm Description

Participate in IPT 6-week intervention group.

Arm Title

UC

Arm Type

No Intervention

Arm Description

Continue with usual care.

Intervention Type

Behavioral

Intervention Name(s)

Interpersonal Psychotherapy

Intervention Description

IPT group-virtual

Primary Outcome Measure Information:

Title

Center for Epidemiologic Studies-Depression Scale

Description

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.

Time Frame

Baseline

Title

Center for Epidemiologic Studies-Depression Scale

Description

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.

Time Frame

6-Week Follow-Up Assessment

Title

Center for Epidemiologic Studies-Depression Scale

Description

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.

Time Frame

6-Month Follow-Up Assessment

Secondary Outcome Measure Information:

Title

Emotional Eating Scale Adapted for Children

Description

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.

Time Frame