AnxietyNCT06140030
Mindfulness Training in Adolescents With Type 1 Diabetes
A study testing Mindfulness training in people with Anxiety and Type 1 Diabetes, run by University of South Florida at 1 site in United States.
Trial summary
Creation of an adaptation of a mindfulness-based stress reduction mobile health application specifically designed for adolescents living with Type 1 diabetes. Aim to determine whether daily mindfulness improves anxiety symptoms in adolescents with Type 1 diabetes. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Anxiety, Type 1 Diabetes, Quality of Life
- What is being tested?
- Mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of Type 1 diabetes for 6 months or longer
- Anxiety score of 5 or higher on the Generalized Anxiety Disorder 7-item scale
- Must be able to read and speak English
Who cannot join
- Clinical diagnosis of a chronic medical condition requiring intensive daily management
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Florida College of Nursing
Tampa, Florida, 33612
Kaitlyn Rechenberg, PhD, 813-974-8544, krechenberg@usf.edu
About this study
Official title: Mindfulness-based Stress Reduction in Adolescents With Type 1 Diabetes
Creation of an adaptation of a mindfulness-based stress reduction mobile health application specifically designed for adolescents living with Type 1 diabetes. Aim to determine whether daily mindfulness improves anxiety symptoms in adolescents with Type 1 diabetes.
- Conditions
- Anxiety, Type 1 Diabetes, Quality of Life
- Being tested
- Mindfulness training
- Medical subject headings
- Anxiety Disorders, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
Mindfulness-training mobile health application
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness training mobile health application | Experimental | Use of a mindfulness training mobile health application Receives: Behavioral: Mindfulness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Symptoms
Generalized Anxiety Disorder 7-item Score range: 0 to 21 Higher scores indicate more anxiety
Measured: 12 weeks
Secondary outcomes (2)
Diabetes-specific quality of life
Pediatric Quality of Life Inventory 3.2 Diabetes Module Range 0 to 100 Higher scores indicate better quality of life
Measured: 12 weeks
Glycemic control
HbA1c
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Oct 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140030
- Sponsor's protocol ID
- STUDY004827
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Stress Reduction in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06140030
- Acronym / sponsor ID
- STUDY004827
- Conditions
- Anxiety, Type 1 Diabetes, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Creation of an adaptation of a mindfulness-based stress reduction mobile health application specifically designed for adolescents living with Type 1 diabetes. Aim to determine whether daily mindfulness improves anxiety symptoms in adolescents with Type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training mobile health application | Experimental | Behavioral: Mindfulness trainingUse of a mindfulness training mobile health application |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Type 1 diabetes for 6 months or longer
- Anxiety score of 5 or higher on the Generalized Anxiety Disorder 7-item scale
- Must be able to read and speak English
Key exclusion criteria (1 listed)
- Clinical diagnosis of a chronic medical condition requiring intensive daily management
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 trainingMindfulness-training mobile health application | Behavioural | Mindfulness training mobile health application |
Primary outcome
Anxiety Symptoms
Time frame: 12 weeks
Generalized Anxiety Disorder 7-item Score range: 0 to 21 Higher scores indicate more anxiety
2 secondary outcomes
Diabetes-specific quality of life
Time frame: 12 weeks
Glycemic control
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness training in people with Anxiety and Type 1 Diabetes, run by University of South Florida 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Symptoms (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2023.