Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Colorado State University
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- Intervention Fidelity
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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)
Recruitment Feasibility: Percentage of Eligible Adolescents who Enroll
Time Frame: 12-months
≥80% eligible adolescents will enroll
Secondary Outcomes
- Training Fidelity: Facilitator Knowledge after Training(6-months)
- Training Fidelity: Facilitator Adherence and Competence during Mock Sessions(6-months)
- Assessment Feasibility: Percentage Accuracy of Protocols(18-months)
- Recruitment Feasibility(12-months)
- Intervention Feasibility: Attendance(6-weeks)
- Intervention Acceptability: Likeability/Credibility Ratings(6-weeks)
- Intervention Acceptability: Qualitative Themes(6-weeks)
- Retention Feasibility: Percentage of Adolescents who Complete Follow-ups(12-months)