Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Obesity Clinical Trial

Official title:

Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04992299
• Other study ID #: 20-2649
• Secondary ID: 1U01AT0110085R01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2023
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adolescent Development
• Depression
• Depressive Disorder
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• Mindfulness-Based Intervention
6-week mindfulness-based intervention of 6 weekly 1 hour group sessions
• Cognitive-Behavioral Therapy
6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions
• Health Education
6-week health education didactic program of 6 weekly 1 hour group sessions

Locations

Country	Name	City	State
United States	University of Colorado Denver/Children's Hospital Colorado	Aurora	Colorado
United States	Uniformed Services University	Bethesda	Maryland
United States	Colorado State University	Fort Collins	Colorado
United States	Children's National Health System	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Colorado State University	Children's National Health System, National Center for Complementary and Integrative Health (NCCIH), Uniformed Services University of the Health Sciences, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Recruitment Feasibility: Percentage of Eligible Adolescents who Enroll	=80% eligible adolescents will enroll	12-months
Secondary	Training Fidelity: Facilitator Knowledge after Training	Facilitators score =80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd	6-months
Secondary	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
Secondary	Recruitment Feasibility	Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal	12-months
Secondary	Intervention Feasibility: Attendance	=80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions	6-weeks
Secondary	Intervention Acceptability: Likeability/Credibility Ratings	=80% adolescent liking/credibility ratings =4 (1=not at all to 5=extremely)	6-weeks
Secondary	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
Secondary	Retention Feasibility: Percentage of Adolescents who Complete Follow-ups	=80% at post-treatment follow-up and =70% at 1-year follow-up	12-months
Secondary	Assessment Feasibility: Percentage Accuracy of Protocols	=95% accuracy on standardized protocol checklists for all assessments	18-months