Trial Outcomes & Findings for Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes (NCT NCT05268393)

Results Overview

The percentage is calculated first by identifying the number of enrolled participants divided by eligible participants. 42 total patients were eligible once screened across the 10 month enrollment period. 42 total then enrolled in the study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

During screening (10 months total)

Results posted on

2025-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	BREATHE-T1D BREATHE-T1D is a 6-week group mindfulness program adapted specifically for teens with type 1 diabetes. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.	BREATHE-T1D Health Education The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Overall Study STARTED	20	22
Overall Study COMPLETED	18	21
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	BREATHE-T1D BREATHE-T1D is a 6-week group mindfulness program adapted specifically for teens with type 1 diabetes. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.	BREATHE-T1D Health Education The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BREATHE-T1D n=20 Participants BREATHE-T1D is a 6-week group mindfulness program adapted specifically for teens with type 1 diabetes. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.	BREATHE-T1D Health Education n=22 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.	Total n=42 Participants Total of all reporting groups
Age, Continuous	14.9 years STANDARD_DEVIATION 1.8 • n=5 Participants	14.7 years STANDARD_DEVIATION 1.9 • n=7 Participants	14.8 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	22 participants n=7 Participants	42 participants n=5 Participants
HbA1c	7.7 percentage STANDARD_DEVIATION 1.1 • n=5 Participants	8.7 percentage STANDARD_DEVIATION 2.5 • n=7 Participants	8.2 percentage STANDARD_DEVIATION 2.0 • n=5 Participants
Depression	58.5 T-score STANDARD_DEVIATION 9.0 • n=5 Participants	56.2 T-score STANDARD_DEVIATION 8.7 • n=7 Participants	56.7 T-score STANDARD_DEVIATION 8.6 • n=5 Participants
Anxiety	58.8 T-score STANDARD_DEVIATION 7.9 • n=5 Participants	57.1 T-score STANDARD_DEVIATION 7.2 • n=7 Participants	57.6 T-score STANDARD_DEVIATION 7.6 • n=5 Participants
Disordered Eating	21.8 units on a scale STANDARD_DEVIATION 11.1 • n=5 Participants	23.4 units on a scale STANDARD_DEVIATION 15.3 • n=7 Participants	22.6 units on a scale STANDARD_DEVIATION 13.3 • n=5 Participants
Diabetes Distress	61.7 units on a scale STANDARD_DEVIATION 23.5 • n=5 Participants	60.1 units on a scale STANDARD_DEVIATION 21.9 • n=7 Participants	60.9 units on a scale STANDARD_DEVIATION 22.4 • n=5 Participants

PRIMARY outcome

Timeframe: During screening (10 months total)

Population: Number of participants screened (42 in all across 10 months were eligible for the study following screening).

The percentage is calculated first by identifying the number of enrolled participants divided by eligible participants. 42 total patients were eligible once screened across the 10 month enrollment period. 42 total then enrolled in the study.

Outcome measures

Outcome measures
Measure	All Participants n=42 Participants All participants prior to randomization.	BREATHE-T1D Health Education The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Percentage of Enrolled of Eligible Participants Screened	42 Participants	—

PRIMARY outcome

Timeframe: During screening (10 months)

Population: All randomized participants

Number of weeks to enroll 10 participants to be randomized 5 per group

Outcome measures

Outcome measures
Measure	All Participants n=42 Participants All participants prior to randomization.	BREATHE-T1D Health Education The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Number of Weeks to Enroll Participants to Form One Cohort	8 weeks Interval 5.0 to 10.0	—

PRIMARY outcome

Timeframe: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

Number of participants with data at each time point.

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=22 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Percentage of Participants With Data Collected Immediate follow up	18 Participants	21 Participants
Percentage of Participants With Data Collected 3 month follow up	18 Participants	21 Participants

PRIMARY outcome

Timeframe: Immediate post-intervention follow-up (2-3 months post baseline)

Population: The aim was for each participant to attend 6 program sessions. Therefore, the number of expected sessions multiplied by the number of participants are reflected in the overall number of units analyzed.

Number of intervention sessions (calculated by multiplying number of expected sessions by number of participants for total possible sessions held) attended divided by total number of intervention sessions expected per group.

Outcome measures

Outcome measures
Measure	All Participants n=108 Sessions All participants prior to randomization.	BREATHE-T1D Health Education n=126 Sessions The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Percentage of Attended Sessions	99 percentage of sessions attended overall	100 percentage of sessions attended overall

PRIMARY outcome

Timeframe: Immediate post-intervention follow-up (2-3 months post-baseline)

Satisfaction report by participants

Outcome measures

Outcome measures
Measure	All Participants n=18 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=21 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Satisfaction With Intervention Program	15 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

Assessed via teen report. Scores are calculated as an average score of all items with a range of 1 (minimum) to 6 (maximum) with higher scores indicating more mindful attention in daily life.

Outcome measures

Outcome measures
Measure	All Participants n=16 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=21 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Mindful Attention Awareness Scale Immediate follow up	3.8 score on a scale Standard Deviation .87	3.8 score on a scale Standard Deviation .99
Mindful Attention Awareness Scale 3 month follow up	3.9 score on a scale Standard Deviation 1.3	3.9 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post-baseline)

Assessed via teen report. Scores are calculated as a total score across all items in the scale with a range of 1 (minimum) to 5 (maximum) and total scores presented are a sum of the sub scale (observing, describing, acting with awareness, nonjudging, and non-reactivity) with possible scores ranging from 5-25 with higher scores indicating more mindfulness.

Outcome measures

Outcome measures
Measure	All Participants n=16 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=21 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Five-Facet Mindfulness Questionnaire Immediate follow up	19.4 score on a scale Standard Deviation 2.2	18.5 score on a scale Standard Deviation 3.3
Five-Facet Mindfulness Questionnaire 3 month follow up	19.9 score on a scale Standard Deviation 2.9	19.1 score on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

Scores are calculated as t-scores with higher scores indicating more depressive symptoms. T-scores (range 0-100) over 55 indicate clinically significant depressive symptoms. Interpretation of t-scores is based on a mean of 50 and standard deviation of 10.

Outcome measures

Outcome measures
Measure	All Participants n=18 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=21 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
PROMIS Depression Short Form - Adolescent Report Immediate follow up	55.9 t-score Standard Deviation 9.4	54.8 t-score Standard Deviation 9.8
PROMIS Depression Short Form - Adolescent Report 3 month follow up	53.0 t-score Standard Deviation 9.6	56.0 t-score Standard Deviation 9.2

SECONDARY outcome

Timeframe: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

Scores are calculated as t-scores (range 0-100) with higher scores indicating more anxiety symptoms.T-scores over 55 indicate clinically significant anxiety symptoms. Interpretation of t-scores is based on a mean of 50 and standard deviation of 10.

Outcome measures

Outcome measures
Measure	All Participants n=18 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=21 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
PROMIS Anxiety Short Form - Adolescent Report Immediate follow up	56.7 T-score Standard Deviation 6.6	53.8 T-score Standard Deviation 8.1
PROMIS Anxiety Short Form - Adolescent Report 3 month follow up	53.8 T-score Standard Deviation 7.6	54.0 T-score Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

Teen report with higher scores indicating more disordered eating behaviors with scores over 25 indicating clinically significant problems. Total scores range from 0 to 64 with higher scores indicating more disordered eating behaviors.

Outcome measures

Outcome measures
Measure	All Participants n=18 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=21 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Diabetes Eating Problems Survey Revised Immediate follow up	18.6 score on a scale Standard Deviation 13.1	18.2 score on a scale Standard Deviation 14.2
Diabetes Eating Problems Survey Revised 3 month follow up	19.3 score on a scale Standard Deviation 13.1	20.0 score on a scale Standard Deviation 16.5

SECONDARY outcome

Timeframe: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

Teen report on the UPPS-P Negative Urgency subscale with higher scores indicating more likelihood to act impulsively when experiencing a negative mood. Scores are calculated with an average which can range from 1(minimum) to 4 (maximum).

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=20 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
UPPS-P Negative Urgency Subscale Immediate follow up	2.52 score on a scale Standard Deviation .85	2.42 score on a scale Standard Deviation .68
UPPS-P Negative Urgency Subscale 3 month follow up	2.65 score on a scale Standard Deviation .58	2.64 score on a scale Standard Deviation .63

SECONDARY outcome

Timeframe: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

Teen report on the Self-Care Inventory, a measure of diabetes management with higher scores indicating better self-care for diabetes. Average scores range from 1 (minimum) to 5 (maximum).

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=20 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Self-Care Inventory Immediate follow up	3.73 units on a scale Standard Deviation .66	3.53 units on a scale Standard Deviation .77
Self-Care Inventory 3 month follow up	3.68 units on a scale Standard Deviation .71	3.48 units on a scale Standard Deviation .76

SECONDARY outcome

Timeframe: Baseline, immediate post intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

The Problem Areas in Diabetes-Teen (PAID-T) is a 14-item measure of diabetes distress in adolescents with type 1 diabetes. Adolescents are asked how often each diabetes-related problem applied to them in the past month, on a six-point Likert scale (ranging from not a problem to serious problem), with scores reflecting a total across 14 items and higher scores indicating greater severity and a clinical cutoff of \>44. Scores can range from 14-84.

Outcome measures

Outcome measures
Measure	All Participants n=18 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=21 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Problem Areas in Diabetes - Teen Immediate follow up	49.8 score on a scale Standard Deviation 22.4	53.1 score on a scale Standard Deviation 22.7
Problem Areas in Diabetes - Teen 3 month follow up	46.8 score on a scale Standard Deviation 19.4	49.1 score on a scale Standard Deviation 21.1

SECONDARY outcome

Timeframe: Baseline, immediate post intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

HbA1c is a measure of an average blood glucose level over the past 3 months and will be abstracted from the medical record as it is assessed at each regular diabetes clinic visit. HbA1c typically ranges from 4% to \>14%.

Outcome measures

Outcome measures
Measure	All Participants n=16 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=16 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Glycemic Control Immediate follow up	7.95 percentage Standard Deviation 1.3	8.79 percentage Standard Deviation 2.5
Glycemic Control 3 month follow up	7.6 percentage Standard Deviation 1.0	8.7 percentage Standard Deviation 2.6

SECONDARY outcome

Timeframe: Week 6 of intervention

Population: All participants were included as these were ratings of sessions, not individual by participant.

Supervisors listened to recordings of sessions for both programs and completed checklists assessing for the number of expected intervention components included in the sessions. Therefore, values reflect the percentage of expected intervention components included across all program sessions calculated at the end of the intervention period (week 6) for each group cohort.

Outcome measures

Outcome measures
Measure	All Participants n=20 Participants All participants prior to randomization.	BREATHE-T1D Health Education n=22 Participants The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. BREATHE-T1D: BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Interventionist Adherence to Session Manuals	100 percentage of intervention components Standard Deviation 0	100 percentage of intervention components Standard Deviation 0

Adverse Events

BREATHE-T1D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BREATHE-T1D Health Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eleanor Mackey

Children's National Hospital

Phone: 202-476-5307

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place