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Completed

NCT Number: NCT04992299

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.

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Key information

Conditions

Type 2 Diabetes Adolescent Development Behavior Behavioral Symptoms Body Weight Depression Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver/Children's Hospital Colorado, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Intervention Fidelity

    Time frame: 12-months

    Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional)

  2. Recruitment Feasibility: Percentage of Eligible Adolescents Who Enroll

    Time frame: 12-months

    ≥80% eligible adolescents will enroll

Secondary outcomes

  1. Training Fidelity: Facilitator Knowledge After Training

    Time frame: 6-months

    Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd

  2. Training Fidelity: Facilitator Adherence and Competence During Mock Sessions

    Time frame: 6-months

    Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd mock group sessions (1=poor to 10=exceptional)

  3. Recruitment Feasibility

    Time frame: 24-months

    Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal

  4. Intervention Feasibility: Attendance

    Time frame: 6-weeks

    ≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions

  5. Intervention Acceptability: Likeability/Credibility Ratings

    Time frame: 6-weeks

    ≥80% adolescent liking/credibility ratings ≥4 (1=not at all to 5=extremely)

  6. Intervention Acceptability: Qualitative Themes

    Time frame: 6-weeks

    Themes indicative of acceptability of interventions, as derived from grounded theory/qualitative analysis of adolescent focus-groups at post-intervention

  7. Retention Feasibility

    Time frame: 12-months

    ≥80% at post-treatment follow-up and ≥70% at 1-year follow-up

  8. Assessment Feasibility: Percentage Accuracy of Protocols

    Time frame: 18-months

    ≥95% accuracy on standardized protocol checklists for all assessments

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • Children's National Research Institute
  • National Center for Complementary and Integrative Health (NCCIH)
  • Uniformed Services University of the Health Sciences
  • University of Colorado, Denver

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 5, 2021
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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