← Back to Search

Cognitive Behavioral Therapy for Depression and Insulin Sensitivity in Adolescents

N/A
Recruiting
Research Sponsored by Colorado State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female
Age 12-17 years
Must not have
Active suicidal ideation or suicidal behavior
Medication affecting mood, weight, cortisol, or insulin sensitivity, including insulin sensitizers (e.g., metformin), anti-depressants, and stimulants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights

Summary

This trial will compare the effects of a cognitive-behavioral therapy group to a health education control group in adolescent girls at-risk for type 2 diabetes with moderate depressive symptoms. The goal is to see if the cognitive-behavioral therapy group can improve insulin sensitivity and prevent worsening of insulin secretion over a one-year follow-up.

Who is the study for?
Adolescent girls aged 12-17 with moderate depression and a high risk for type 2 diabetes are eligible. They must have a family history of diabetes, be English-speaking, and have a BMI in the top 15% for their age and sex. Girls who already have type 2 diabetes, are pregnant or breastfeeding, on certain medications affecting mood or insulin sensitivity, or suffering from major psychiatric disorders cannot participate.
What is being tested?
The trial is testing if cognitive-behavioral therapy can improve insulin sensitivity better than just health education in adolescent girls at risk for type 2 diabetes with depressive symptoms. The study will follow participants over one year to see changes in eating habits, physical activity, sleep patterns, and stress hormones.
What are the potential side effects?
Cognitive-behavioral therapy generally has no direct side effects but discussing sensitive topics may sometimes cause emotional discomfort. Health education sessions typically do not involve any side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am female.
Select...
I am between 12 and 17 years old.
Select...
My BMI is in the top 15% for my age and sex.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had thoughts or actions of harming myself.
Select...
I am not taking medication that affects mood, weight, cortisol, or insulin sensitivity.
Select...
I have type 2 diabetes based on my blood sugar or HbA1c levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Depressive symptoms
Insulin secretion
Insulin sensitivity
Secondary study objectives
Cortisol diurnal rhythm
Daily cortisol output
Disinhibited eating
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive-behavioral therapy groupExperimental Treatment1 Intervention
Six-session cognitive-behavioral therapy group program designed as a prevention of depression intervention for adolescents at-risk for depression. The program is facilitated by a psychologist. Sessions are weekly for 1-hour.
Group II: Health education groupActive Control1 Intervention
Six-session health education group program designed as a health education curriculum for teenagers. The program is facilitated by a psychologist. Sessions are weekly for 1-hour.

Find a Location

Who is running the clinical trial?

Colorado State UniversityLead Sponsor
131 Previous Clinical Trials
38,018 Total Patients Enrolled
3 Trials studying Insulin Sensitivity
119 Patients Enrolled for Insulin Sensitivity
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,634 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
342 Previous Clinical Trials
410,268 Total Patients Enrolled

Media Library

Cognitive-behavioral therapy group Clinical Trial Eligibility Overview. Trial Name: NCT03263351 — N/A
Insulin Sensitivity Research Study Groups: Cognitive-behavioral therapy group, Health education group
Insulin Sensitivity Clinical Trial 2023: Cognitive-behavioral therapy group Highlights & Side Effects. Trial Name: NCT03263351 — N/A
Cognitive-behavioral therapy group 2023 Treatment Timeline for Medical Study. Trial Name: NCT03263351 — N/A
~25 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top