COMPLETED

Depression & Insulin Sensitivity in Adolescents

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

There has been a rise in type 2 diabetes (T2D) rates in adolescents, disproportionately in girls from disadvantaged racial/ethnic groups. This group of girls also is at heightened risk for depression, and depression and T2D are linked. Depressive symptoms are a risk factor for worsening of insulin sensitivity, one if the major precursors to T2D. In preliminary studies, the investigators found that a brief cognitive-behavioral therapy group decreased depressive symptoms and prevented worsening of insulin sensitivity in adolescent girls at-risk for T2D with moderate depressive symptoms. The aims of this study are: 1) to assess the efficacy of a cognitive-behavioral therapy depression group vs. a health education control group for improving insulin sensitivity and preserving insulin secretion in racially/ethnically diverse adolescent girls at-risk for T2D with moderate depressive symptoms over a 1-year follow-up; 2) to evaluate changes in eating, physical activity, and sleep as explanatory and 3) to test changes in cortisol factors as explanatory.

Official Title

Depression and Insulin Sensitivity in Adolescents

Quick Facts

Study Start:2017-10-01
Study Completion:2025-05-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03263351

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Age 12-17 years
  3. * Body mass index (BMI) ≥85th percentile for age \& sex
  4. * Center for Epidemiologic Studies-Depression Scale (CES-D) \>20
  5. * English speaking
  6. * ≥1 first- or second-degree family member with type 2 diabetes (T2D), prediabetes, or gestational diabetes
  7. * Good general health
  1. * Pregnancy or breastfeeding
  2. * Type 2 diabetes as indicated by fasting glucose≥126 mg/dL or 2-hour glucose\>200 mg/dL or Hba1c\>=6.5
  3. * Medication affecting mood, weight, cortisol, or insulin sensitivity, including insulin sensitizers (e.g., metformin), anti-depressants, and stimulants
  4. * 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
  5. * Psychotherapy or structured weight loss program
  6. * Active suicidal ideation or suicidal behavior

Contacts and Locations

Principal Investigator

Lauren B Shomaker, PhD
PRINCIPAL_INVESTIGATOR
Colorado State University

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: Colorado State University

  • Lauren B Shomaker, PhD, PRINCIPAL_INVESTIGATOR, Colorado State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-10-01
Study Completion Date2025-05-26

Study Record Updates

Study Start Date2017-10-01
Study Completion Date2025-05-26

Terms related to this study

Additional Relevant MeSH Terms

  • Type2 Diabetes
  • Type 2 Diabetes Mellitus
  • Insulin Sensitivity
  • Insulin Resistance
  • Depression
  • Adolescent Obesity