Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Colorado State University
Study ID
NCT04992299
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Mindfulness-Based Intervention — BEHAVIORAL
    6-week mindfulness-based intervention of 6 weekly 1 hour group sessions
  • Cognitive-Behavioral Therapy — BEHAVIORAL
    6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions
  • Health Education — BEHAVIORAL
    6-week health education didactic program of 6 weekly 1 hour group sessions

Study Details

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.

Key Dates

Start date
May 5, 2022
Status verified
Mar 2026
Primary completion
Dec 21, 2024
Completion
May 26, 2025

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Mindfulness-Based Intervention
    6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
  • Active Comparator: Cognitive-Behavioral Therapy
    6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
  • Other: Health Education
    6-week group program providing didactic information on adolescent health topics

Primary Outcome Measure

Intervention Fidelity [ Time Frame: 12-months ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Colorado Denver/Children's Hospital ColoradoAuroraColorado80045-
Colorado State UniversityFort CollinsColorado80523-
Children's National Health SystemWashington D.C.District of Columbia20010-
Uniformed Services UniversityBethesdaMaryland20814-

Find similar trials in Aurora, CO

By condition
DepressionObesity / overweightType 2 diabetes
By specialty
PsychiatryMental healthBehavioral healthEndocrinologyMetabolic healthWeight loss
By research site
University of Colorado Denver/Children's Hospital Colorado· Aurora, COColorado State University· Fort Collins, COChildren's National Health System· Washington D.C., DCUniformed Services University· Bethesda, MD

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