Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

— IPAP  

Official title:

Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06056453
• Other study ID #: 20-3033
• Status: Completed
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: July 14, 2023

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Interpersonal Psychotherapy
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Behavioral:
• Interpersonal Psychotherapy
IPT group-virtual

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Psychological Association (APA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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