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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Depressive symptoms

Insulin secretion

Insulin sensitivity

Secondary outcome measures

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Colorado State UniversityLead Sponsor

125 Previous Clinical Trials

38,159 Total Patients Enrolled

2 Trials studying Insulin Sensitivity

69 Patients Enrolled for Insulin Sensitivity

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,597 Total Patients Enrolled

National Center for Advancing Translational Sciences (NCATS)NIH

321 Previous Clinical Trials

401,549 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research demand for individuals of a certain age, or is it open to all adults?

"This trial is focused on participants aged between 12 and 17 years old."

Answered by AI

What is the total sample size for this investigation?

"Affirmative. Clinicaltrials.gov corroborates that this experiment is actively enrolling participants, with a first posting date of October 1st 2017 and the most recent edit on July 21st 2022. 200 patients need to be enrolled from only one trial site."

Answered by AI

What criteria must potential participants meet to qualify for this research project?

"To be eligible for acceptance into this study, individuals afflicted with depression must fall between the age range of 12 to 17. This research project is enlisting a total of 200 participants."

Answered by AI

Are there any empty slots remaining in this medical trial?

"As reported on clinicaltrials.gov, this medical trial has been actively recruiting since October 1st 2017 and was last updated on July 21 2022."

Answered by AI

What is the desired outcome of this medical experiment?

"The prime purpose of this investigation, which will span around 12 months, is to assess the alleviation of depressive symptoms. Additionally, Cortisol diurnal rhythm (Salivary cortisol by home collection throughout the day), Sleep duration as measured via actigraphy and Disinhibited eating using an Emotional Eating Scale adapted for Children depression scale are being studied as secondary objectives."

Answered by AI

Recent research and studies

Journal of Analytical ToxicologyJournal

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Andrews, Scott A., and Harry J. Colvin. 1989. “Verification of Intoximeter 3000 Breath Alcohol Concentration by Magnesium Perchlorate Tube Method in Long-term Field Program”. Journal of Analytical Toxicology. Oxford University Press (OUP). doi:10.1093/jat/13.2.113.

Depression and AnxietyJournal

Prevention of Insulin Resistance in Adolescents at Risk for Type 2 Diabetes with Depressive Symptoms: 1-year Follow-up of a Randomized Trial

Shomaker, Lauren B., Nichole R. Kelly, Rachel M. Radin, Omni L. Cassidy, Lisa M. Shank, Sheila M. Brady, Andrew P. Demidowich, et al.. 2017. “Prevention of Insulin Resistance in Adolescents at Risk for Type 2 Diabetes with Depressive Symptoms: 1-year Follow-up of a Randomized Trial”. Depression and Anxiety. Wiley. doi:10.1002/da.22617.

clinicaltrials.govStudy

Depression & Insulin Sensitivity in Adolescents

2017. "Depression & Insulin Sensitivity in Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03263351.

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