Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Study Overview
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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.

Official Title
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Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Conditions
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Type 2 Diabetes, Depression, Insulin Resistance, Obesity, Adolescent Development

Intervention / Treatment
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* Behavioral: Mindfulness-Based Intervention
* Behavioral: Cognitive-Behavioral Therapy
* Behavioral: Health Education


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Intervention<br>6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction | Behavioral: Mindfulness-Based Intervention<br>* 6-week mindfulness-based intervention of 6 weekly 1 hour group sessions<br>|
| Active Comparator: Cognitive-Behavioral Therapy<br>6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression | Behavioral: Cognitive-Behavioral Therapy<br>* 6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions<br>|
| Other: Health Education<br>6-week group program providing didactic information on adolescent health topics | Behavioral: Health Education<br>* 6-week health education didactic program of 6 weekly 1 hour group sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Fidelity | Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional) | 12-months | 
| Recruitment Feasibility: Percentage of Eligible Adolescents who Enroll | ≥80% eligible adolescents will enroll | 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Training Fidelity: Facilitator Knowledge after Training | Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd | 6-months | 
| Training Fidelity: Facilitator Adherence and Competence during Mock Sessions | Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd mock group sessions (1=poor to 10=exceptional) | 6-months | 
| Recruitment Feasibility | Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal | 12-months | 
| Intervention Feasibility: Attendance | ≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions | 6-weeks | 
| Intervention Acceptability: Likeability/Credibility Ratings | ≥80% adolescent liking/credibility ratings ≥4 (1=not at all to 5=extremely) | 6-weeks | 
| Intervention Acceptability: Qualitative Themes | Themes indicative of acceptability of interventions, as derived from grounded theory/qualitative analysis of adolescent focus-groups at post-intervention | 6-weeks | 
| Retention Feasibility: Percentage of Adolescents who Complete Follow-ups | ≥80% at post-treatment follow-up and ≥70% at 1-year follow-up | 12-months | 
| Assessment Feasibility: Percentage Accuracy of Protocols | ≥95% accuracy on standardized protocol checklists for all assessments | 18-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent Development, Obesity, Type 2 Diabetes