CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Mindfulness-Based Intervention +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04992299
NCT04992299N/ACompleted

Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Colorado State University·interventional·Posted Aug 5, 2021·Updated Apr 2, 2026

In Brief

A clinical study evaluating Mindfulness-Based Intervention, Cognitive-Behavioral Therapy, and 1 other intervention for Type 2 Diabetes and 4 related conditions. Completed, enrolled 120 participants across 4 sites.

Detailed Summary

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 Details

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 5, 2021
Enrollment StartMay 5, 2022
Primary CompletionDec 21, 2024
Study CompletionMay 26, 2025
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 4.9 years ago

Interventions

Mindfulness-Based Interventionbehavioral

6-week mindfulness-based intervention of 6 weekly 1 hour group sessions

Cognitive-Behavioral Therapybehavioral

6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions

Health Educationbehavioral

6-week health education didactic program of 6 weekly 1 hour group sessions