Reducing Stress in Adolescents and Young Adults With Type 1 Diabetes to Improve Diabetes Care
T1D
2 other identifiers
interventional
60
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 28, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJune 2, 2017
May 1, 2017
1.1 years
April 28, 2016
May 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolic Control
Hemoglobin A1c (HbA1c)
Change from Baseline at 3 months, Change from Baseline at 6 months
Secondary Outcomes (7)
Regimen Adherence (objective)
Change from Baseline at 3 months, Change from Baseline at 6 months
Regimen Adherence (daily diary)
Change from Baseline at 3 months, Change from Baseline at 6 months
Regimen Adherence (self-reported)
Change from Baseline at 3 months, Change from Baseline at 6 months
Psychological Stress (general)
Change from Baseline at 3 months, Change from Baseline at 6 months
Psychological Stress (diabetes-related)
Change from Baseline at 3 months, Change from Baseline at 6 months
- +2 more secondary outcomes
Study Arms (3)
Cognitive Behavioral Therapy
EXPERIMENTALHains' adaptation of cognitive behavioral therapy for adolescents and young adults with type 1 diabetes
Mindfulness Based Stress Reduction
EXPERIMENTALSabinga's adaptation of Mindfulness Based Stress Reduction for adolescents and young adults with type 1 diabetes
Diabetes Support and Education
ACTIVE COMPARATORInvestigator developed peer support group and diabetes education
Interventions
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.
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.
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).
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wayne State University School of Medicine
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah Ellis, Ph.D
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Family Medicine and Public Health Sciences Wayne State University School of Medicine
Study Record Dates
First Submitted
April 28, 2016
First Posted
May 3, 2016
Study Start
September 1, 2015
Primary Completion
October 1, 2016
Study Completion
May 1, 2017
Last Updated
June 2, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share