Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Colorado State University (CSU)

Status: Completed

Conditions: Adolescent Development; Insulin Resistance; Obesity; Depression; Type 2 Diabetes

Treatments: Behavioral: Health Education; Behavioral: Mindfulness-Based Intervention; Behavioral: Cognitive-Behavioral Therapy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04992299

20-2649

1U01AT011008 (U.S. NIH Grant/Contract)

5R01AT011008 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Mindfulness-Based Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness-Based Intervention

Cognitive-Behavioral Therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Cognitive-Behavioral Therapy

Health Education

Other group

Description:

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

Treatment:

Behavioral: Health Education