- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04992299
Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
September 14, 2023 updated by: Colorado State University
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.
Study Overview
Status
Active, not recruiting
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lauren Shomaker, PhD
- Phone Number: (970)491-3217
- Email: lauren.shomaker@colostate.edu
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Denver/Children's Hospital Colorado
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Fort Collins, Colorado, United States, 80523
- Colorado State University
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Health System
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Maryland
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Bethesda, Maryland, United States, 20814
- Uniformed Services University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness-Based Intervention
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
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6-week mindfulness-based intervention of 6 weekly 1 hour group sessions
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Active Comparator: Cognitive-Behavioral Therapy
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
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6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions
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Other: Health Education
6-week group program providing didactic information on adolescent health topics
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6-week health education didactic program of 6 weekly 1 hour group sessions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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12-months
|
Recruitment Feasibility: Percentage of Eligible Adolescents who Enroll
Time Frame: 12-months
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≥80% eligible adolescents will enroll
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12-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training Fidelity: Facilitator Knowledge after Training
Time Frame: 6-months
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Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd
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6-months
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Training Fidelity: Facilitator Adherence and Competence during Mock Sessions
Time Frame: 6-months
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Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd mock group sessions (1=poor to 10=exceptional)
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6-months
|
Recruitment Feasibility
Time Frame: 12-months
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Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal
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12-months
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Intervention Feasibility: Attendance
Time Frame: 6-weeks
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≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions
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6-weeks
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Intervention Acceptability: Likeability/Credibility Ratings
Time Frame: 6-weeks
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≥80% adolescent liking/credibility ratings ≥4 (1=not at all to 5=extremely)
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6-weeks
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Intervention Acceptability: Qualitative Themes
Time Frame: 6-weeks
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Themes indicative of acceptability of interventions, as derived from grounded theory/qualitative analysis of adolescent focus-groups at post-intervention
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6-weeks
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Retention Feasibility: Percentage of Adolescents who Complete Follow-ups
Time Frame: 12-months
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≥80% at post-treatment follow-up and ≥70% at 1-year follow-up
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12-months
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Assessment Feasibility: Percentage Accuracy of Protocols
Time Frame: 18-months
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≥95% accuracy on standardized protocol checklists for all assessments
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18-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2022
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
August 31, 2025
Study Registration Dates
First Submitted
July 21, 2021
First Submitted That Met QC Criteria
July 29, 2021
First Posted (Actual)
August 5, 2021
Study Record Updates
Last Update Posted (Actual)
September 15, 2023
Last Update Submitted That Met QC Criteria
September 14, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-2649
- 1U01AT011008 (U.S. NIH Grant/Contract)
- 5R01AT011008 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be made available upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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