Depression & Insulin Sensitivity in Adolescents

NCT03263351 | Completed DMC

• 2 other identifiers: 4185R01DK111604
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Depressive symptoms

  Center for Epidemiologic Studies-Depression Scale (CES-D) total score

  1-year

• Insulin sensitivity

  Whole body insulin sensitivity index estimated from 2-hour oral glucose tolerance test

  1-year

• Insulin secretion

  Oral disposition index estimated from 2-hour oral glucose tolerance test

  1-year

Secondary Outcomes (6)

• Disinhibited eating

  1-year

• Physical activity

  1-year

• Physical inactivity

  1-year

• Sleep

  1-year

• Cortisol diurnal rhythm

  1-year

Study Arms (2)

Cognitive-behavioral therapy group

EXPERIMENTAL

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.

Behavioral: Cognitive-behavioral therapy group

Health education group

ACTIVE COMPARATOR

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.

Behavioral: Health education group

Interventions

Cognitive-behavioral therapy group BEHAVIORAL

Psychoeducation on depression; cognitive restructuring of negative thoughts; engagement in pleasant activities; healthy rewards; stress and coping.

Also known as: Blues Program

Cognitive-behavioral therapy group

Health education group BEHAVIORAL

Didactic health knowledge about interpersonal violence; basic nutrition guidance; sun safety; depression and signs of suicide; gang violence; substance use.

Also known as: Hey-Durham

Health education group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator
• Children's Hospital Colorado: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Shomaker LB, Gulley L, Hilkin AM, Clark E, Annameier S, Rao S, Rockette-Wagner B, Kriska A, Wright KP Jr, Stice E, Nadeau KJ, Kelsey MM. Design of a randomized controlled trial to decrease depression and improve insulin sensitivity in adolescents: Mood and INsulin sensitivity to prevent Diabetes (MIND). Contemp Clin Trials. 2018 Dec;75:19-28. doi: 10.1016/j.cct.2018.10.007. Epub 2018 Oct 17.

  PMID: 30342256 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Depression; Pediatric Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Behavioral Symptoms; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lauren B Shomaker, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research staff who assess outcomes will be blinded to condition assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled behavioral trial with two conditions - cognitive-behavioral therapy group or health education group - run in parallel.

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 28, 2017
• Study Start: October 1, 2017
• Primary Completion: March 31, 2025
• Study Completion: May 26, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)