IPAP: Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IPT Participate in IPT 6-week intervention group. |
Behavioral: Interpersonal Psychotherapy
IPT group-virtual
|
| No Intervention: UC Continue with usual care. |
Outcome Measures
Primary Outcome Measures
- Center for Epidemiologic Studies-Depression Scale [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.
- Center for Epidemiologic Studies-Depression Scale [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.
- 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
- 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.
- 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.
- 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.
- 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).
- 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).
- 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).
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
- American Psychological Association (APA)
Investigators
- Principal Investigator: Lauren Gulley, PhD, Colorado State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-3033