Type 2 DiabetesNCT04992299

Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

A study testing Mindfulness-Based Intervention, Cognitive-Behavioral Therapy and Health Education in people with Type 2 Diabetes and Depression, run by Colorado State University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes, Depression, Insulin Resistance
What is being tested?: Mindfulness-Based Intervention, Cognitive-Behavioral Therapy and Health Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 4 sitesUnited States
Study dates: 5 May 2022to 26 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of Colorado Denver/Children's Hospital Colorado
Aurora, Colorado, 80045
Uniformed Services University
Bethesda, Maryland, 20814
Colorado State University
Fort Collins, Colorado, 80523
Children's National Health System
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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.

Conditions: Type 2 Diabetes, Depression, Insulin Resistance, Obesity, Adolescent Development
Being tested: Mindfulness-Based Intervention, Cognitive-Behavioral Therapy, Health Education
Keywords: Adolescent Development, Obesity, Type 2 Diabetes
Medical subject headings: Diabetes Mellitus, Type 2, Depression, Insulin Resistance, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-Based InterventionBehavioural
6-week mindfulness-based intervention of 6 weekly 1 hour group sessions
Cognitive-Behavioral TherapyBehavioural
6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions
Health EducationBehavioural
6-week health education didactic program of 6 weekly 1 hour group sessions

Study groups in NCT04992299
Study group	Role	What they receive
Mindfulness-Based Intervention	Experimental	6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction Receives: Behavioral: Mindfulness-Based Intervention
Cognitive-Behavioral Therapy	Active comparator	6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression Receives: Behavioral: Cognitive-Behavioral Therapy
Health Education	Other	6-week group program providing didactic information on adolescent health topics Receives: Behavioral: Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

Training Fidelity: Facilitator Knowledge After Training
Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd
Measured: 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)
Measured: 6-months
Recruitment Feasibility
Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal
Measured: 24-months
Intervention Feasibility: Attendance
≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions
Measured: 6-weeks
Intervention Acceptability: Likeability Ratings
≥80% adolescent liking ratings ≥4 (1=not at all to 5=extremely)
Measured: 6-weeks
Retention Feasibility
≥80% at post-treatment follow-up and ≥70% at 1-year follow-up
Measured: 12-months
Percentage Accuracy of Protocols
≥95% accuracy on standardized protocol checklists for all assessments
Measured: 18-months
Intervention Acceptability: Credibility Ratings
≥80% adolescent credibility/helpfulness ratings ≥4 (1=not at all to 5=extremely)
Measured: 6-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 202226 May 2025

First posted5 Aug 2021
Study start5 May 2022
Primary completion21 Dec 2024
Study completion26 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04992299
Sponsor's protocol ID: 20-2649
Other IDs: 1U01AT011008, 5R01AT011008
Status last verified: Aug 2026
First submitted: 21 Jul 2021
Last updated: 2 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will be made available upon reasonable request.

Publications

Perzow SED, Chen M, Bothwell S, Gulley LD, Lucas-Thompson RG, Pyle L, Thompson T, Sanchez N, Estrada DE, Tanofsky-Kraff M, Kelsey MK, Mackey ER, Shomaker LB. Fidelity of Mindfulness Training and Delivery for Adolescent Mental and Metabolic Health. Mindfulness (N Y). 2026;17(10):2928-2941. doi: 10.1007/s12671-026-02975-8. Epub 2026 Sep 3.
PubMed 42802734

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
ClinicalTrials.gov ID: NCT04992299
Acronym / sponsor ID: 20-2649
Conditions: Type 2 Diabetes, Depression, Insulin Resistance, Obesity, Adolescent Development
Keywords: Adolescent Development, Obesity, Type 2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Colorado State UniversityUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH), University of Colorado, Denver, Children's National Research Institute, Uniformed Services University of the Health Sciences
Study start: 5 May 2022 (actual)
Primary completion: 21 Dec 2024 (actual)
Study completion: 26 May 2025 (actual)
First posted: 5 Aug 2021 (actual)
Results: Posted 2 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Mindfulness-Based Intervention	Experimental	Behavioral: Mindfulness-Based Intervention6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
Cognitive-Behavioral Therapy	Active comparator	Behavioral: Cognitive-Behavioral Therapy6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
Health Education	Other	Behavioral: Health Education6-week group program providing didactic information on adolescent health topics

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness-Based Intervention6-week mindfulness-based intervention of 6 weekly 1 hour group sessions	Behavioural	Mindfulness-Based Intervention
Cognitive-Behavioral Therapy6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions	Behavioural	Cognitive-Behavioral Therapy
Health Education6-week health education didactic program of 6 weekly 1 hour group sessions	Behavioural	Health Education

Primary outcome

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

8 secondary outcomes

Training Fidelity: Facilitator Knowledge After Training
Time frame: 6-months
Training Fidelity: Facilitator Adherence and Competence During Mock Sessions
Time frame: 6-months
Recruitment Feasibility
Time frame: 24-months
Intervention Feasibility: Attendance
Time frame: 6-weeks
Intervention Acceptability: Likeability Ratings
Time frame: 6-weeks
Retention Feasibility
Time frame: 12-months
Percentage Accuracy of Protocols
Time frame: 18-months
Intervention Acceptability: Credibility Ratings
Time frame: 6-weeks

Results and safety

Results posted to the registry on 2 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindfulness-Based Intervention	37	31
Cognitive-Behavioral Therapy	43	31
Health Education	40	38

Primary outcome: Intervention Fidelity

Time frame: 12-months. Median (Inter-Quartile Range). Unit: Expert ratings ranging from 0-100%

Measure	Mindfulness-Based Intervention n = 37	Cognitive-Behavioral Therapy n = 43	Health Education n = 40
Facilitator Competence	90 (80 to 100)	90 (80 to 92.5)	97.5 (90 to 100)
Facilitator Adherence	100 (95 to 100)	90.5 (90 to 92.5)	96 (90 to 100)

Population analysed: 49 total sessions were rated by experts, about 1/3 of randomly selected sessions across arms; facilitators were not considered enrolled but contributed to this assessment

Primary outcome: Recruitment Feasibility: Percentage of Eligible Adolescents Who Enroll

Time frame: 12-months. Number. Unit: Number who chose to enroll

Measure	Total Who Enrolled n = 138
Value	120

Population analysed: 138 is the number of participants who were determined to be eligible or possibly eligible after starting the screening/baseline assessment phase; 120 out of 138=87%

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline through end of the follow-up period, up to 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness-Based Intervention	0 of 37 (0%)	29 of 37 (78.4%)	0 of 37
Cognitive-Behavioral Therapy	1 of 43 (2.3%)	27 of 43 (62.8%)	0 of 43
Health Education	0 of 40 (0%)	35 of 40 (87.5%)	0 of 40

Limitations and caveats (from the sponsor): By design, this multisite pilot and feasibility randomized controlled trial was centered on the assessment of training and implementation fidelity and feasibility and acceptability of the study protocol and interventions. Intervention effects cannot be determined until a powered trial is undertaken.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42802734Perzow SED, Chen M, Bothwell S, Gulley LD, Lucas-Thompson RG, Pyle L, Thompson T, Sanchez N, Estrada DE, Tanofsky-Kraff M, Kelsey MK, Mackey ER, Shomaker LB. Fidelity of Mindfulness Training and Delivery for Adolescent Mental and Metabolic Health. Mindfulness (N Y). 2026;17(10):2928-2941. doi: 10.1007/s12671-026-02975-8. Epub 2026 Sep 3.
Individual participant dataSharing planned: No. Data will be made available upon reasonable request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention Fidelity (time frame: 12-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04992299, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.