Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Rates of type 2 diabetes (T2D) in adolescents have escalated. Adolescent-onset is associated with greater health comorbidities and shorter life expectancy than adult-onset T2D. T2D is preventable by decreasing insulin resistance, a physiological precursor to T2D. T2D prevention standard-of-care is lifestyle intervention to decrease insulin resistance through weight loss; yet, this approach is insufficiently effective in adolescents. Adolescents at risk for T2D frequently experience depression, which predicts worsening insulin resistance and T2D onset, even after accounting for obesity. Mindfulness-based intervention (MBI) may offer a targeted, integrative health approach to decrease depression, and thereby, ameliorate insulin resistance in adolescents at risk for T2D. In a single-site, pilot randomized controlled trial (RCT), we established initial feasibility/acceptability of a 6-week group MBI program, Learning to BREATHE, in adolescents at risk for T2D. We demonstrated feasible single-site recruitment, randomization, retention, protocol adherence, and MBI acceptability/credibility in the target population. Our preliminary data also suggest MBI may lead to greater reductions in stress-related behavior, vs. CBT and a didactic/health education (HealthEd) control group. The current study is multisite, pilot RCT to test multisite fidelity, feasibility, and acceptability in preparation for a future multisite efficacy trial that will have strong external validity, timely recruitment, and long-term follow-up. Adolescents (N=120) at risk for T2D will be randomized to MBI vs. CBT vs. HealthEd and followed for 1-year. Specific aims are to: (1) test multisite fidelity of training and implementation of 6-week group MBI, CBT, and HealthEd, to teens at risk for T2D; (2) evaluate multisite feasibility/acceptability of recruitment, retention, and adherence for an RCT of 6-week group MBI, CBT, HealthEd with 6-week and 1-year follow-up; and (3) modify intervention training/implementation and protocol procedures in preparation for a future, fully-powered multisite efficacy RCT.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Obesity; Insulin Resistance; Type 2 Diabetes; Adolescent Development
• Intervention / Treatment: Behavioral: Mindfulness-Based Intervention; Behavioral: Cognitive-Behavioral Therapy; Behavioral: Health Education

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Shomaker, PhD; Phone Number: (970)491-3217; Email: lauren.shomaker@colostate.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver/Children's Hospital Colorado
    • Fort Collins, Colorado, United States, 80523
      • Colorado State University
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Health System
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Uniformed Services University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adolescent: Age 12-17 years
• At-risk for T2D:

Overweight/obesity: BMI ≥85 percentile for age and sex Family history of T2D: ≥1 relative with T2D, prediabetes, or gestational diabetes in first- or second- degree relative, referring to a biological parent, sibling, aunt, uncle, or grandparent

• Elevated depression symptoms: Center for Epidemiological Studies - Depression Scale (CES-D) total score >20
• Good general health: Medical history/physical examination
• Parent/guardian: Parent/guardian of qualifying participant

Exclusion Criteria:

• Major medical problem: including T2D, assessed at baseline/screening as fasting glucose ≥126 mg/dL or 2-hour glucose ≥200 mg/dL, or any other significant medical condition reported during the medical history/physical examination
• Major psychiatric problem: Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 psychiatric diagnosis, including anorexia nervosa, bipolar disorder, bulimia nervosa, conduct disorder, major depressive disorder (MDD), obsessive compulsive disorder, panic disorder, posttraumatic stress disorder, psychosis, and substance/tobacco/alcohol use disorder
• Regular medication use affecting mood, insulin, and/or weight: anti-anxiety medications, anti-depressants, anti-psychotics, insulin sensitizers, mood stabilizers, stimulants, and weight loss drugs
• Active suicidal ideation or behavior
• Regular psychotherapy or structured weight loss treatment
• Pregnancy: as reported by adolescent participants (females)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Intervention; 6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction	Behavioral: Mindfulness-Based Intervention; 6-week mindfulness-based intervention of 6 weekly 1 hour group sessions
Active Comparator: Cognitive-Behavioral Therapy; 6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression	Behavioral: Cognitive-Behavioral Therapy; 6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions
Other: Health Education; 6-week group program providing didactic information on adolescent health topics	Behavioral: Health Education; 6-week health education didactic program of 6 weekly 1 hour group sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Fidelity	Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional)	12-months
Recruitment Feasibility: Percentage of Eligible Adolescents who Enroll	≥80% eligible adolescents will enroll	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Training Fidelity: Facilitator Knowledge after Training	Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd	6-months
Training Fidelity: Facilitator Adherence and Competence during Mock Sessions	Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd mock group sessions (1=poor to 10=exceptional)	6-months
Recruitment Feasibility	Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal	12-months
Intervention Feasibility: Attendance	≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions	6-weeks
Intervention Acceptability: Likeability/Credibility Ratings	≥80% adolescent liking/credibility ratings ≥4 (1=not at all to 5=extremely)	6-weeks
Intervention Acceptability: Qualitative Themes	Themes indicative of acceptability of interventions, as derived from grounded theory/qualitative analysis of adolescent focus-groups at post-intervention	6-weeks
Retention Feasibility: Percentage of Adolescents who Complete Follow-ups	≥80% at post-treatment follow-up and ≥70% at 1-year follow-up	12-months
Assessment Feasibility: Percentage Accuracy of Protocols	≥95% accuracy on standardized protocol checklists for all assessments	18-months

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: University of Colorado, Denver; National Center for Complementary and Integrative Health (NCCIH); Uniformed Services University of the Health Sciences; Children's National Health System

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Type 2 Diabetes; Adolescent Development
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Mood Disorders; Endocrine System Diseases; Diabetes Mellitus; Hyperinsulinism; Depression; Depressive Disorder; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: 20-2649; 1U01AT011008 (U.S. NIH Grant/Contract); 5R01AT011008 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be made available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No