Type 1 DiabetesT1DNCT02760303
Reducing Stress in Adolescents and Young Adults With Type 1 Diabetes to Improve Diabetes Care
A study testing Cognitive Behavioral Therapy, Mindfulness Based Stress Reduction and Diabetes Support and Education in people with Type 1 Diabetes, run by Wayne State University at 1 site in United States.
Trial summary
Adolescence and young adulthood may be particularly stressful developmental periods due to the numerous transitions into new roles and the need for increased independence. Stress can affect metabolic control in older adolescents and young adults with T1D directly through its impact on cortisol and other hormones that… Read more about this study
- Who is it for?
- Ages 16 to 20 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Cognitive Behavioral Therapy, Mindfulness Based Stress Reduction and Diabetes Support and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to May 2017
- 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 16 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 16 years, 0 months to 20 years, 11 months
- Diagnosed with type 1 diabetes for at least six months
- Poor metabolic control as defined by HbA1c >=9%
Who cannot join
- Mental health conditions that might compromise data integrity (e.g., developmental delay, psychosis, suicidality)
- Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)
- Inability to speak or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University School of Medicine
Detroit, Michigan, 48202
About this study
Official title: Reducing Stress in Adolescents and Young Adults With T1D to Improve Diabetes Care
Adolescence and young adulthood may be particularly stressful developmental periods due to the numerous transitions into new roles and the need for increased independence. Stress can affect metabolic control in older adolescents and young adults with T1D directly through its impact on cortisol and other hormones that affect insulin metabolism.
The proposed study is a pilot randomized clinical trial using a three-group randomized, repeated measures design to assess the efficacy of two treatments (Mindfulness Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy or (CBT) versus an attention control condition for older adolescents and young adults with poorly controlled Type 1 diabetes. As a pilot study, the goal of the research is to test recruitment and retention procedures, finalize intervention measures, training, and fidelity protocols, and estimate effect sizes for a larger clinical trial.
Read the detailed description
This study will use a randomized, repeated measures design. A sample of 125 participants will be recruited and consented from the Children's Hospital of Michigan and outpatient diabetes clinics affiliated with the Detroit Medical Center. 108 will be randomized to one of three treatment conditions (remaining participants are expected to consent but not enroll or fail to initiate treatment). These participants will be enrolled in 3 cohorts of 30-36 participants.
Measures will be administered at 3 home-based study visits to maximize participant convenience. The initial study visit (Visit 1) will be scheduled at the beginning of the study. Visit 2 will coincide with the end of treatment which is approximately 3 months after the initial study visit. Visit 3 is the 3-month follow up and will be scheduled about 6 months after the initial study visit. At each visit, participants will complete questionnaires assessing their current diabetes management, stressors, quality of life, mental health, and demographic characteristics. These questionnaires will be completed using Qualtrics accessed via the internet on a university laptop computer. A research assistant will download the participant's glucose meter to obtain the frequency of blood glucose testing during the two weeks preceding data collection. The research assistant will also assist participants with providing a blood sample via fingerstick (HbA1c) and saliva samples by mouth (cortisol, Visits 1 and 2 only). All participants will be asked to take part in an exit interview at Visit 3 to obtain feedback on the treatment they received.
After Visit 1, participants will be randomized using a 1:1:1 ratio to MBSR, CBT, or Diabetes Support and Education (DSE). All three treatments are group format meeting (10-12 participants per group) for nine consecutive weeks at a location convenient to the participants. In MBSR treatment focuses on the instruction and practice of mindfulness techniques, such as meditation and yoga, and the application of these practices to everyday activities. CBT utilizes activities to understand how thoughts affect emotions and behaviors, the application of these activities to current stressors, and strategies to apply these new skills to future stressors. The DSE group is the attention control condition; DSE participants will receive diabetes education via a support group format. All group sessions will be audiotaped for treatment fidelity monitoring and assessment. There are no planned research interventions for the DSE group.
- Conditions
- Type 1 Diabetes
- Being tested
- Cognitive Behavioral Therapy, Mindfulness Based Stress Reduction, Diabetes Support and Education
- Keywords
- insulin dependent diabetes mellitus, adolescents and young adults, stress reduction, metabolic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT
Participants will attend group therapy sessions, once a week for 9 weeks. The focus of these sessions will be the thought-emotion-behavior linkages as outlined by cognitive-behavioral theory. Activities will illustrate how thoughts affect emotions and behaviors, the application of these activities to current stressors, and strategies to apply these new skills to future stressors.
Mindfulness Based Stress ReductionBehavioural
Also called MBSR
Participants will attend group therapy sessions, once a week for 9 weeks. The focus of these sessions will be understanding how to gain control over one's thoughts and feelings using relaxation, meditation, and other mindfulness-based techniques. Activities will focus on the instruction and practice of mindfulness techniques, such as meditation and yoga, and the application of these practices to everyday activities.
Diabetes Support and EducationBehavioural
Also called DSE
Participants will attend group therapy sessions, once a week for 9 weeks. Participants will receive diabetes education via a support group format. The focus of these sessions will be peer group social support and non-adherence diabetes education topics (e.g., emergency preparedness, smoking and diabetes).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Hains' adaptation of cognitive behavioral therapy for adolescents and young adults with type 1 diabetes Receives: Behavioral: Cognitive Behavioral Therapy |
| Mindfulness Based Stress Reduction | Experimental | Sabinga's adaptation of Mindfulness Based Stress Reduction for adolescents and young adults with type 1 diabetes Receives: Behavioral: Mindfulness Based Stress Reduction |
| Diabetes Support and Education | Active comparator | Investigator developed peer support group and diabetes education Receives: Behavioral: Diabetes Support and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Control
Hemoglobin A1c (HbA1c)
Measured: Change from Baseline at 3 months, Change from Baseline at 6 months
Secondary outcomes (7)
Regimen Adherence (objective)
Frequency of Glucose Meter Testing
Measured: Change from Baseline at 3 months, Change from Baseline at 6 months
Regimen Adherence (daily diary)
24 Hour Recall of Diabetes Adherence Behavior
Measured: Change from Baseline at 3 months, Change from Baseline at 6 months
Regimen Adherence (self-reported)
Diabetes Management Scale (DMS)
Measured: Change from Baseline at 3 months, Change from Baseline at 6 months
Psychological Stress (general)
Perceived Stress Scale (PSS)
Measured: Change from Baseline at 3 months, Change from Baseline at 6 months
Psychological Stress (diabetes-related)
Diabetes Stress Questionnaire (DSQ)
Measured: Change from Baseline at 3 months, Change from Baseline at 6 months
Psychological Stress (attitudes)
Hassles and Uplifts Scale
Measured: Change from Baseline at 3 months, Change from Baseline at 6 months
Diabetes Quality of Life
Diabetes Quality of Life Scale
Measured: Change from Baseline at 3 months, Change from Baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startSep 2015
- Primary completionOct 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Ellis, Ph.D., Wayne State University
- Investigators
- Deborah Ellis, Ph.D, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760303
- Sponsor's protocol ID
- 066115B3E
- Other IDs
- R01DK059067
- Acronym
- T1D
- Status last verified
- May 2017
- First submitted
- 28 Apr 2016
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Stress in Adolescents and Young Adults With T1D to Improve Diabetes Care
- ClinicalTrials.gov ID
- NCT02760303
- Acronym / sponsor ID
- T1D / 066115B3E
- Conditions
- Type 1 Diabetes
- Keywords
- insulin dependent diabetes mellitus, adolescents and young adults, stress reduction, metabolic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 3 May 2016 (estimated)
- 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.
Adolescence and young adulthood may be particularly stressful developmental periods due to the numerous transitions into new roles and the need for increased independence. Stress can affect metabolic control in older adolescents and young adults with T1D directly through its impact on cortisol and other hormones that affect insulin metabolism.
The proposed study is a pilot randomized clinical trial using a three-group randomized, repeated measures design to assess the efficacy of two treatments (Mindfulness Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy or (CBT) versus an attention control condition for older adolescents and young adults with poorly controlled Type 1 diabetes. As a pilot study, the goal of the research is to test recruitment and retention procedures, finalize intervention measures, training, and fidelity protocols, and estimate effect sizes for a larger clinical trial.
Detailed description
This study will use a randomized, repeated measures design. A sample of 125 participants will be recruited and consented from the Children's Hospital of Michigan and outpatient diabetes clinics affiliated with the Detroit Medical Center. 108 will be randomized to one of three treatment conditions (remaining participants are expected to consent but not enroll or fail to initiate treatment). These participants will be enrolled in 3 cohorts of 30-36 participants.
Measures will be administered at 3 home-based study visits to maximize participant convenience. The initial study visit (Visit 1) will be scheduled at the beginning of the study. Visit 2 will coincide with the end of treatment which is approximately 3 months after the initial study visit. Visit 3 is the 3-month follow up and will be scheduled about 6 months after the initial study visit. At each visit, participants will complete questionnaires assessing their current diabetes management, stressors, quality of life, mental health, and demographic characteristics. These questionnaires will be completed using Qualtrics accessed via the internet on a university laptop computer. A research assistant will download the participant's glucose meter to obtain the frequency of blood glucose testing during the two weeks preceding data collection. The research assistant will also assist participants with providing a blood sample via fingerstick (HbA1c) and saliva samples by mouth (cortisol, Visits 1 and 2 only). All participants will be asked to take part in an exit interview at Visit 3 to obtain feedback on the treatment they received.
After Visit 1, participants will be randomized using a 1:1:1 ratio to MBSR, CBT, or Diabetes Support and Education (DSE). All three treatments are group format meeting (10-12 participants per group) for nine consecutive weeks at a location convenient to the participants. In MBSR treatment focuses on the instruction and practice of mindfulness techniques, such as meditation and yoga, and the application of these practices to everyday activities. CBT utilizes activities to understand how thoughts affect emotions and behaviors, the application of these activities to current stressors, and strategies to apply these new skills to future stressors. The DSE group is the attention control condition; DSE participants will receive diabetes education via a support group format. All group sessions will be audiotaped for treatment fidelity monitoring and assessment. There are no planned research interventions for the DSE group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyHains' adaptation of cognitive behavioral therapy for adolescents and young adults with type 1 diabetes |
| Mindfulness Based Stress Reduction | Experimental | Behavioral: Mindfulness Based Stress ReductionSabinga's adaptation of Mindfulness Based Stress Reduction for adolescents and young adults with type 1 diabetes |
| Diabetes Support and Education | Active comparator | Behavioral: Diabetes Support and EducationInvestigator developed peer support group and diabetes education |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 16 years, 0 months to 20 years, 11 months
- Diagnosed with type 1 diabetes for at least six months
- Poor metabolic control as defined by HbA1c >=9%
Key exclusion criteria (3 listed)
- Mental health conditions that might compromise data integrity (e.g., developmental delay, psychosis, suicidality)
- Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)
- Inability to speak or read English
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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBTParticipants will attend group therapy sessions, once a week for 9 weeks. The focus of these sessions will be the thought-emotion-behavior linkages as outlined by cognitive-behavioral theory. Activities will illustrate how thoughts affect emotions and behaviors, the application of these activities to current stressors, and strategies to apply these new skills to future stressors. | Behavioural | Cognitive Behavioral Therapy |
| Mindfulness Based Stress ReductionAlso: MBSRParticipants will attend group therapy sessions, once a week for 9 weeks. The focus of these sessions will be understanding how to gain control over one's thoughts and feelings using relaxation, meditation, and other mindfulness-based techniques. Activities will focus on the instruction and practice of mindfulness techniques, such as meditation and yoga, and the application of these practices to everyday activities. | Behavioural | Mindfulness Based Stress Reduction |
| Diabetes Support and EducationAlso: DSEParticipants will attend group therapy sessions, once a week for 9 weeks. Participants will receive diabetes education via a support group format. The focus of these sessions will be peer group social support and non-adherence diabetes education topics (e.g., emergency preparedness, smoking and diabetes). | Behavioural | Diabetes Support and Education |
Primary outcome
Metabolic Control
Time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Hemoglobin A1c (HbA1c)
7 secondary outcomes
Regimen Adherence (objective)
Time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Regimen Adherence (daily diary)
Time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Regimen Adherence (self-reported)
Time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Psychological Stress (general)
Time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Psychological Stress (diabetes-related)
Time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Psychological Stress (attitudes)
Time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Diabetes Quality of Life
Time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- 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.
Deborah Ellis, Ph.D principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy, Mindfulness Based Stress Reduction and Diabetes Support and Education in people with Type 1 Diabetes, run by Wayne State University 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 3 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 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Metabolic Control (time frame: Change from Baseline at 3 months, Change from Baseline at 6 months). 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 2 Jun 2017.