Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
- Conditions
- Type 2 DiabetesDepressionAdolescent DevelopmentInsulin ResistanceObesity
- Interventions
- Behavioral: Health EducationBehavioral: Mindfulness-Based InterventionBehavioral: Cognitive-Behavioral Therapy
- Registration Number
- NCT04992299
- Lead Sponsor
- Colorado State University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Health Education Health Education 6-week group program providing didactic information on adolescent health topics Mindfulness-Based Intervention Mindfulness-Based Intervention 6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction Cognitive-Behavioral Therapy Cognitive-Behavioral Therapy 6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
- Primary Outcome Measures
Name Time Method Intervention Fidelity 12-months Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional)
Recruitment Feasibility: Percentage of Eligible Adolescents who Enroll 12-months ≥80% eligible adolescents will enroll
- Secondary Outcome Measures
Name Time Method Training Fidelity: Facilitator Knowledge after Training 6-months Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd
Training Fidelity: Facilitator Adherence and Competence during Mock Sessions 6-months Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd mock group sessions (1=poor to 10=exceptional)
Assessment Feasibility: Percentage Accuracy of Protocols 18-months ≥95% accuracy on standardized protocol checklists for all assessments
Recruitment Feasibility 12-months Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal
Intervention Feasibility: Attendance 6-weeks ≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions
Intervention Acceptability: Likeability/Credibility Ratings 6-weeks ≥80% adolescent liking/credibility ratings ≥4 (1=not at all to 5=extremely)
Intervention Acceptability: Qualitative Themes 6-weeks Themes indicative of acceptability of interventions, as derived from grounded theory/qualitative analysis of adolescent focus-groups at post-intervention
Retention Feasibility: Percentage of Adolescents who Complete Follow-ups 12-months ≥80% at post-treatment follow-up and ≥70% at 1-year follow-up
Trial Locations
- Locations (4)
University of Colorado Denver/Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Colorado State University
🇺🇸Fort Collins, Colorado, United States
Uniformed Services University
🇺🇸Bethesda, Maryland, United States
Children's National Health System
🇺🇸Washington, District of Columbia, United States