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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

No Placebo-Only Group

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

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I am female.

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I am between 12 and 17 years old.

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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:

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I have not had thoughts or actions of harming myself.

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I am not taking medication that affects mood, weight, cortisol, or insulin sensitivity.

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I have type 2 diabetes based on my blood sugar or HbA1c levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met