Reducing Stress in Adolescents and Young Adults With Type 1 Diabetes to Improve Diabetes Care
NCT ID: NCT02760303
Last Updated: 2017-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-09-30
2017-05-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cognitive Behavioral Therapy
Hains' adaptation of cognitive behavioral therapy for adolescents and young adults with type 1 diabetes
Cognitive Behavioral Therapy
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 Reduction
Sabinga's adaptation of Mindfulness Based Stress Reduction for adolescents and young adults with type 1 diabetes
Mindfulness Based Stress Reduction
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 Education
Investigator developed peer support group and diabetes education
Diabetes Support and Education
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).
Interventions
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Cognitive Behavioral Therapy
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 Reduction
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 Education
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with type 1 diabetes for at least six months
3. Poor metabolic control as defined by HbA1c \>=9%
Exclusion Criteria
2. Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)
3. Inability to speak or read English
16 Years
20 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Wayne State University
OTHER
Responsible Party
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Deborah Ellis, Ph.D.
Professor of Family Medicine and Public Health Sciences Wayne State University School of Medicine
Principal Investigators
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Deborah Ellis, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
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Wayne State University School of Medicine
Detroit, Michigan, United States
Countries
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Other Identifiers
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066115B3E
Identifier Type: -
Identifier Source: org_study_id
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