Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-05

Study Completion Date

2025-05-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Depression Insulin Resistance Obesity Adolescent Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Mindfulness-Based Intervention

6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction

Group Type EXPERIMENTAL

Mindfulness-Based Intervention

Intervention Type BEHAVIORAL

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

Cognitive-Behavioral Therapy

6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression

Group Type ACTIVE_COMPARATOR

Cognitive-Behavioral Therapy

Intervention Type BEHAVIORAL

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

Health Education

6-week group program providing didactic information on adolescent health topics

Group Type OTHER

Health Education

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness-Based Intervention

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

Intervention Type BEHAVIORAL

Cognitive-Behavioral Therapy

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

Intervention Type BEHAVIORAL

Health Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes