type1diabetesBREATHE-T1DNCT05268393
Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes
A study testing BREATHE-T1D in people with type1diabetes, run by Children's National Research Institute at 1 site in United States.
Trial summary
Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regimen, including daily insulin administration/pump management, frequent blood glucose checks, and careful track-ing of food intake, places a high-stress burden on patients and their families. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- type1diabetes
- What is being tested?
- BREATHE-T1D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2022to 31 Jul 2023
- 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
- No healthy volunteers
- Child
Who may be able to join
- age 12-17y
- T1D, with at least 1-year duration of illness
- negative affectivity, defined as clinically elevated scores (T-score >55 indicating at least mild depression/anxiety symptoms on either the PROMIS short form-depression and/or anxiety scales)
- A1c >7.5%
- English-speaking
Who cannot join
- no cognitive or developmental delays which would interfere with their ability to participate in the study
- are able and willing to complete questionnaires and intervention via the internet
- do not have severe depression or active or recent (within the past two months) suicidal ideation
- have no other serious medical conditions (e.g., cystic fibrosis, cancer).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1
Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regimen, including daily insulin administration/pump management, frequent blood glucose checks, and careful track-ing of food intake, places a high-stress burden on patients and their families. Adolescence is a particularly risky time for T1D management given a marked decline in treatment adherence and glycemic control. Over 80% of adolescents with T1D have poor glycemic control (A1c >7.5%), and one significant risk factor is the increase in negative affectivity, including depression and anxiety symptoms, that distinguish adolescents with T1D. Elevated depression and anxiety symptoms affect 40% of teens with T1D. Preliminary data support the notion that negative affectivity contributes to diminished treatment adherence and worsening of glycemic control, partially through the effects of negative affectivity on stress-related behavior such as maladaptive eating behavior (e.g., dietary restriction, uncontrolled eating patterns, and insulin omission for weight control). There is no gold-standard approach to address the poor glycemic control seen in adolescents with T1D. The creation of novel, targeted interventions, tailored for the developmental needs of adolescents with T1D and the particular burdens of coping with their chronic illness, are needed. Mindfulness-based interventions delivered to adolescents without T1D, including the team's preliminary work in teens with depression and weight-related disorders, have shown promise in treating negative affectivity, maladaptive eating behavior, and health outcomes. A mindfulness-based approach may be well-suited for adolescents with T1D, but given that the mechanisms of association among negative affectivity, stress-related behavior, and self-care are unique to individuals with T1D, interventions must be specifically tailored for this population. The goal of this study is to, therefore, adapt an existing 6-session mindfulness-based intervention, Learning to BREATHE, for use with adolescents with T1D (BREATHE-T1D). The first specific aim of the study is to adapt BREATHE for adolescents with T1D and to adapt a relevant and credible health education comparison curriculum (HealthEd-T1D). The second aim is to carry out a 2-way pilot randomized controlled trial to evaluate the feasibility and acceptability of BREATHE-T1D and HealthEd-T1D. The result of the current study will be a feasible and acceptable mindfulness intervention and comparison curriculum that can be evaluated in an efficacy trial. The multidisciplinary study team contributes complementary areas of expertise in adolescents with T1D, behavioral intervention development, negative affectivity and maladaptive eating behavior, adolescent mindfulness-based intervention, qualitative data analysis, and delivery of behavioral health interventions via telehealth. The study's innovative approach will enable the investigators to establish a feasible/acceptable intervention tailored for adolescents with T1D, leading to a future proposal for a full-scale efficacy trial.
- Conditions
- type1diabetes
- Being tested
- BREATHE-T1D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREATHE-T1DBehavioural
BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| BREATHE-T1D | Experimental | BREATHE-T1D is a 6-week group mindfulness program adapted specifically for teens with type 1 diabetes. Receives: Behavioral: BREATHE-T1D |
| BREATHE-T1D Health Education | Placebo comparator | The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. Receives: Behavioral: BREATHE-T1D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Enrolled of Eligible Participants Screened
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.
Measured: During screening (10 months total)
Number of Weeks to Enroll Participants to Form One Cohort
Number of weeks to enroll 10 participants to be randomized 5 per group
Measured: During screening (10 months)
Percentage of Participants With Data Collected
Number of participants with data at each time point.
Measured: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Percentage of Attended Sessions
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.
Measured: Immediate post-intervention follow-up (2-3 months post baseline)
Satisfaction With Intervention Program
Satisfaction report by participants
Measured: Immediate post-intervention follow-up (2-3 months post-baseline)
Secondary outcomes (10)
Mindful Attention Awareness Scale
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.
Measured: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Five-Facet Mindfulness Questionnaire
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.
Measured: Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post-baseline)
PROMIS Depression Short Form - Adolescent Report
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.
Measured: Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
PROMIS Anxiety Short Form - Adolescent Report
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.
Measured: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Diabetes Eating Problems Survey Revised
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.
Measured: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
UPPS-P Negative Urgency Subscale
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).
Measured: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Self-Care Inventory
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).
Measured: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Problem Areas in Diabetes - Teen
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.
Measured: Baseline, immediate post intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Glycemic Control
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%.
Measured: Baseline, immediate post intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Interventionist Adherence to Session Manuals
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.
Measured: Week 6 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start31 Mar 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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 (2)Papers the sponsor has linked to this study.
- Other trials for type1diabetesStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Eleanor Mackey, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268393
- Sponsor's protocol ID
- 15464
- Other IDs
- R34AT011035
- Acronym
- BREATHE-T1D
- Status last verified
- Jan 2025
- First submitted
- 15 Feb 2022
- Last updated
- 7 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lupini F, Basch M, Cooke F, Vagadori J, Gutierrez-Colina A, Kelly KP, Streisand R, Shomaker L, Mackey ER. BREATHE-T1D: Using iterative mixed methods to adapt a mindfulness-based intervention for adolescents with type 1 diabetes: Design and development. Contemp Clin Trials. 2024 Jul;142:107551. doi: 10.1016/j.cct.2024.107551. Epub 2024 Apr 29.
PubMed 38692428Basch M, Lupini F, Ho S, Dagnachew M, Gutierrez-Colina AM, Patterson Kelly K, Shomaker L, Streisand R, Vagadori J, Mackey E. Mindfulness-based group intervention for adolescents with type 1 diabetes: initial findings from a pilot and feasibility randomized controlled trial. J Pediatr Psychol. 2024 Oct 1;49(10):769-779. doi: 10.1093/jpepsy/jsae071.
PubMed 39212647
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1
- ClinicalTrials.gov ID
- NCT05268393
- Acronym / sponsor ID
- BREATHE-T1D / 15464
- Conditions
- type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Posted 7 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regimen, including daily insulin administration/pump management, frequent blood glucose checks, and careful track-ing of food intake, places a high-stress burden on patients and their families. Adolescence is a particularly risky time for T1D management given a marked decline in treatment adherence and glycemic control. Over 80% of adolescents with T1D have poor glycemic control (A1c >7.5%), and one significant risk factor is the increase in negative affectivity, including depression and anxiety symptoms, that distinguish adolescents with T1D. Elevated depression and anxiety symptoms affect 40% of teens with T1D. Preliminary data support the notion that negative affectivity contributes to diminished treatment adherence and worsening of glycemic control, partially through the effects of negative affectivity on stress-related behavior such as maladaptive eating behavior (e.g., dietary restriction, uncontrolled eating patterns, and insulin omission for weight control). There is no gold-standard approach to address the poor glycemic control seen in adolescents with T1D. The creation of novel, targeted interventions, tailored for the developmental needs of adolescents with T1D and the particular burdens of coping with their chronic illness, are needed. Mindfulness-based interventions delivered to adolescents without T1D, including the team's preliminary work in teens with depression and weight-related disorders, have shown promise in treating negative affectivity, maladaptive eating behavior, and health outcomes. A mindfulness-based approach may be well-suited for adolescents with T1D, but given that the mechanisms of association among negative affectivity, stress-related behavior, and self-care are unique to individuals with T1D, interventions must be specifically tailored for this population. The goal of this study is to, therefore, adapt an existing 6-session mindfulness-based intervention, Learning to BREATHE, for use with adolescents with T1D (BREATHE-T1D). The first specific aim of the study is to adapt BREATHE for adolescents with T1D and to adapt a relevant and credible health education comparison curriculum (HealthEd-T1D). The second aim is to carry out a 2-way pilot randomized controlled trial to evaluate the feasibility and acceptability of BREATHE-T1D and HealthEd-T1D. The result of the current study will be a feasible and acceptable mindfulness intervention and comparison curriculum that can be evaluated in an efficacy trial. The multidisciplinary study team contributes complementary areas of expertise in adolescents with T1D, behavioral intervention development, negative affectivity and maladaptive eating behavior, adolescent mindfulness-based intervention, qualitative data analysis, and delivery of behavioral health interventions via telehealth. The study's innovative approach will enable the investigators to establish a feasible/acceptable intervention tailored for adolescents with T1D, leading to a future proposal for a full-scale efficacy trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BREATHE-T1D | Experimental | Behavioral: BREATHE-T1DBREATHE-T1D is a 6-week group mindfulness program adapted specifically for teens with type 1 diabetes. |
| BREATHE-T1D Health Education | Placebo comparator | Behavioral: BREATHE-T1DThe health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age 12-17y
- T1D, with at least 1-year duration of illness
- negative affectivity, defined as clinically elevated scores (T-score >55 indicating at least mild depression/anxiety symptoms on either the PROMIS short form-depression and/or anxiety scales)
- A1c >7.5%
- English-speaking
Key exclusion criteria (4 listed)
- no cognitive or developmental delays which would interfere with their ability to participate in the study
- are able and willing to complete questionnaires and intervention via the internet
- do not have severe depression or active or recent (within the past two months) suicidal ideation
- have no other serious medical conditions (e.g., cystic fibrosis, cancer).
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 |
|---|---|---|
| BREATHE-T1DBREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes. | Behavioural | BREATHE-T1D, BREATHE-T1D Health Education |
Primary outcome
Percentage of Enrolled of Eligible Participants Screened
Time frame: During screening (10 months total)
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.
Number of Weeks to Enroll Participants to Form One Cohort
Time frame: During screening (10 months)
Number of weeks to enroll 10 participants to be randomized 5 per group
Percentage of Participants With Data Collected
Time frame: 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.
Percentage of Attended Sessions
Time frame: Immediate post-intervention follow-up (2-3 months post baseline)
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.
Satisfaction With Intervention Program
Time frame: Immediate post-intervention follow-up (2-3 months post-baseline)
Satisfaction report by participants
10 secondary outcomes
Mindful Attention Awareness Scale
Time frame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Five-Facet Mindfulness Questionnaire
Time frame: Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post-baseline)
PROMIS Depression Short Form - Adolescent Report
Time frame: Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
PROMIS Anxiety Short Form - Adolescent Report
Time frame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Diabetes Eating Problems Survey Revised
Time frame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
UPPS-P Negative Urgency Subscale
Time frame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Self-Care Inventory
Time frame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Problem Areas in Diabetes - Teen
Time frame: Baseline, immediate post intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Glycemic Control
Time frame: Baseline, immediate post intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Interventionist Adherence to Session Manuals
Time frame: Week 6 of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38692428Lupini F, Basch M, Cooke F, Vagadori J, Gutierrez-Colina A, Kelly KP, Streisand R, Shomaker L, Mackey ER. BREATHE-T1D: Using iterative mixed methods to adapt a mindfulness-based intervention for adolescents with type 1 diabetes: Design and development. Contemp Clin Trials. 2024 Jul;142:107551. doi: 10.1016/j.cct.2024.107551. Epub 2024 Apr 29.
- Results publication: PubMed 39212647Basch M, Lupini F, Ho S, Dagnachew M, Gutierrez-Colina AM, Patterson Kelly K, Shomaker L, Streisand R, Vagadori J, Mackey E. Mindfulness-based group intervention for adolescents with type 1 diabetes: initial findings from a pilot and feasibility randomized controlled trial. J Pediatr Psychol. 2024 Oct 1;49(10):769-779. doi: 10.1093/jpepsy/jsae071.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BREATHE-T1D in people with type1diabetes, run by Children's National Research Institute at 1 site in United States.
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 5 inclusion and 4 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 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 7 Feb 2025). 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?
Percentage of Enrolled of Eligible Participants Screened (time frame: During screening (10 months total)). The study lists 5 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 NCT05268393, which also lists 2 linked publications.
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 7 Feb 2025.