Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome

Conditions
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Interpersonal Psychotherapy, Polycystic Ovary Syndrome

Intervention / Treatment
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* Behavioral: Interpersonal Psychotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |