Trial Outcomes & Findings for Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents (NCT NCT04992299)
NCT ID: NCT04992299
Last Updated: 2026-04-02
Results Overview
Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
12-months
Results posted on
2026-04-02
Participant Flow
The first participant was enrolled on May 5, 2022, and enrollment was completed for this trial on September 9, 2023.
994 phone pre-screens were initiated. 160 of these were estimated to be eligible and proceeded to the screening phase. Of these, 22 were determined to be ineligible and 18 either did not complete the screening process or declined to continue in the study prior to randomization.
Participant milestones
| Measure |
Mindfulness-Based Intervention
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
|
Cognitive-Behavioral Therapy
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
|
Health Education
6-week group program providing didactic information on adolescent health topics
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
43
|
40
|
|
Overall Study
COMPLETED
|
31
|
31
|
38
|
|
Overall Study
NOT COMPLETED
|
6
|
12
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
Baseline characteristics by cohort
| Measure |
Mindfulness-Based Intervention
n=37 Participants
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
|
Cognitive-Behavioral Therapy
n=43 Participants
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
|
Health Education
n=40 Participants
6-week group program providing didactic information on adolescent health topics
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
37 Participants
n=5 Participants
|
43 Participants
n=5 Participants
|
40 Participants
n=10 Participants
|
120 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
25 Participants
n=5 Participants
|
23 Participants
n=10 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=10 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=10 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
24 Participants
n=5 Participants
|
22 Participants
n=10 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
BMI Status
Overweight BMI 85-94th percentile
|
9 Participants
n=5 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
23 Participants
n=5 Participants
|
|
BMI Status
Obesity BMI >=95th percentile
|
28 Participants
n=5 Participants
|
36 Participants
n=5 Participants
|
33 Participants
n=10 Participants
|
97 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-monthsPopulation: 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
Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional)
Outcome measures
| Measure |
Health Education
n=17 GroupSession
6-week group program providing didactic information on adolescent health topics
|
Mindfulness-Based Intervention
n=14 GroupSession
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
|
Cognitive-Behavioral Therapy
n=18 GroupSession
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
|
|---|---|---|---|
|
Intervention Fidelity
Facilitator Adherence
|
96 Expert ratings ranging from 0-100%
Interval 90.0 to 100.0
|
100 Expert ratings ranging from 0-100%
Interval 95.0 to 100.0
|
90.5 Expert ratings ranging from 0-100%
Interval 90.0 to 92.5
|
|
Intervention Fidelity
Facilitator Competence
|
97.5 Expert ratings ranging from 0-100%
Interval 90.0 to 100.0
|
90 Expert ratings ranging from 0-100%
Interval 80.0 to 100.0
|
90 Expert ratings ranging from 0-100%
Interval 80.0 to 92.5
|
PRIMARY outcome
Timeframe: 12-monthsPopulation: 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%
≥80% eligible adolescents will enroll
Outcome measures
| Measure |
Health Education
6-week group program providing didactic information on adolescent health topics
|
Mindfulness-Based Intervention
n=138 Participants
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
|
Cognitive-Behavioral Therapy
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
|
|---|---|---|---|
|
Recruitment Feasibility: Percentage of Eligible Adolescents Who Enroll
|
—
|
120 Number who chose to enroll
|
—
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: Number of facilitators who were trained in each intervention type, who scored at least 80% or higher on post-training knowledge test; facilitators were not considered enrolled but contributed to this assessment
Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd
Outcome measures
| Measure |
Health Education
n=9 Participants
6-week group program providing didactic information on adolescent health topics
|
Mindfulness-Based Intervention
n=11 Participants
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
|
Cognitive-Behavioral Therapy
n=10 Participants
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
|
|---|---|---|---|
|
Training Fidelity: Facilitator Knowledge After Training
|
9 Participants
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: Facilitators were not considered enrolled but contributed to this assessment; facilitators were not considered enrolled but contributed to this assessment
Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd mock group sessions (1=poor to 10=exceptional)
Outcome measures
| Measure |
Health Education
n=18 GroupSession
6-week group program providing didactic information on adolescent health topics
|
Mindfulness-Based Intervention
n=18 GroupSession
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
|
Cognitive-Behavioral Therapy
n=18 GroupSession
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
|
|---|---|---|---|
|
Training Fidelity: Facilitator Adherence and Competence During Mock Sessions
Facilitator Competence
|
82.5 Expert ratings ranging from 0-100%
Interval 80.0 to 93.8
|
80 Expert ratings ranging from 0-100%
Interval 80.0 to 85.0
|
86 Expert ratings ranging from 0-100%
Interval 85.0 to 87.5
|
|
Training Fidelity: Facilitator Adherence and Competence During Mock Sessions
Facilitator Adherence
|
80 Expert ratings ranging from 0-100%
Interval 80.0 to 92.0
|
85 Expert ratings ranging from 0-100%
Interval 80.0 to 90.0
|
90 Expert ratings ranging from 0-100%
Interval 90.0 to 92.0
|
SECONDARY outcome
Timeframe: 24-monthsPopulation: Number of months it took to enroll the 120 target sample
Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal
Outcome measures
| Measure |
Health Education
6-week group program providing didactic information on adolescent health topics
|
Mindfulness-Based Intervention
n=120 Participants
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
|
Cognitive-Behavioral Therapy
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
|
|---|---|---|---|
|
Recruitment Feasibility
|
—
|
16 Months
|
—
|
SECONDARY outcome
Timeframe: 6-weeks≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions
Outcome measures
| Measure |
Health Education
n=40 Participants
6-week group program providing didactic information on adolescent health topics
|
Mindfulness-Based Intervention
n=37 Participants
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
|
Cognitive-Behavioral Therapy
n=43 Participants
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
|
|---|---|---|---|
|
Intervention Feasibility: Attendance
|
30 Participants
|
32 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 6-weeks≥80% adolescent liking/credibility ratings ≥4 (1=not at all to 5=extremely)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6-weeksThemes indicative of acceptability of interventions, as derived from grounded theory/qualitative analysis of adolescent focus-groups at post-intervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12-monthsPopulation: Number who completed follow-up
≥80% at post-treatment follow-up and ≥70% at 1-year follow-up
Outcome measures
| Measure |
Health Education
n=40 Participants
6-week group program providing didactic information on adolescent health topics
|
Mindfulness-Based Intervention
n=37 Participants
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
|
Cognitive-Behavioral Therapy
n=43 Participants
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
|
|---|---|---|---|
|
Retention Feasibility
6-week/post-intervention follow-up
|
38 Participants
|
35 Participants
|
33 Participants
|
|
Retention Feasibility
1-year follow-up
|
38 Participants
|
31 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 18-months≥95% accuracy on standardized protocol checklists for all assessments
Outcome measures
Outcome data not reported
Adverse Events
Health Education
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Mindfulness-Based Intervention
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Cognitive-Behavioral Therapy
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Health Education
n=40 participants at risk
6-week group program providing didactic information on adolescent health topics
|
Mindfulness-Based Intervention
n=37 participants at risk
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
|
Cognitive-Behavioral Therapy
n=43 participants at risk
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
|
|---|---|---|---|
|
Psychiatric disorders
Hospitalization for psychological concerns
|
0.00%
0/40 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
0.00%
0/37 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
2.3%
1/43 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
Other adverse events
| Measure |
Health Education
n=40 participants at risk
6-week group program providing didactic information on adolescent health topics
|
Mindfulness-Based Intervention
n=37 participants at risk
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
|
Cognitive-Behavioral Therapy
n=43 participants at risk
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Elevated lab results
|
65.0%
26/40 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
51.4%
19/37 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
34.9%
15/43 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
|
General disorders
Elevated blood pressure at any point from baseline to 1-year follow-up
|
20.0%
8/40 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
10.8%
4/37 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
9.3%
4/43 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
|
Psychiatric disorders
Mental health concerns assessed at any point from baseline (within past year) to 1-year follow-up
|
55.0%
22/40 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
43.2%
16/37 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
39.5%
17/43 • From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place