Cognitive-behavioral therapy for depression in adolescent girls at risk for type 2 diabetes
Depression and Insulin Sensitivity in Adolescents
This study tests if cognitive-behavioral therapy can help adolescent girls at risk for type 2 diabetes feel less depressed and improve their insulin sensitivity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | Female |
| Sponsor | Colorado State University Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT03263351 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of cognitive-behavioral therapy (CBT) on improving insulin sensitivity and reducing depressive symptoms in adolescent girls aged 12-17 who are at risk for type 2 diabetes. Participants will be divided into a CBT group and a health education control group, with assessments conducted over a one-year follow-up period. The study aims to evaluate changes in eating, physical activity, and sleep patterns as potential mediators of the intervention's effects. The focus is on racially and ethnically diverse girls with moderate depressive symptoms and a family history of type 2 diabetes.
Who should consider this trial
Good fit: Ideal candidates are female adolescents aged 12-17 with a BMI in the 85th percentile or higher and moderate depressive symptoms.
Not a fit: Patients who are pregnant, have diagnosed type 2 diabetes, or major psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health and metabolic outcomes for adolescent girls at risk for type 2 diabetes.
How similar studies have performed: Preliminary studies have shown promise in using cognitive-behavioral therapy to improve depressive symptoms and insulin sensitivity in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age 12-17 years * Body mass index (BMI) ≥85th percentile for age \& sex * Center for Epidemiologic Studies-Depression Scale (CES-D) \>20 * English speaking * ≥1 first- or second-degree family member with type 2 diabetes (T2D), prediabetes, or gestational diabetes * Good general health Exclusion Criteria: * Pregnancy or breastfeeding * Type 2 diabetes as indicated by fasting glucose≥126 mg/dL or 2-hour glucose\>200 mg/dL or Hba1c\>=6.5 * Medication affecting mood, weight, cortisol, or insulin sensitivity, including insulin sensitizers (e.g., metformin), anti-depressants, and stimulants * Major psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment, including major depressive disorder, bipolar disorder, posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, schizophrenia, conduct disorder, alcohol and substance abuse, and anorexia/bulimia nervosa * Psychotherapy or structured weight loss program * Active suicidal ideation or suicidal behavior
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Lauren B Shomaker, PhD
- Email: lauren.shomaker@colostate.edu
- Phone: (970)491-3217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.