Reducing Stress in Adolescents and Young Adults With Type 1 Diabetes to Improve Diabetes Care
Completed · Not applicable
Conditions studied: Type 1 Diabetes
In brief
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.
Key facts
- Study ID
- NCT02760303
- Run by
- Wayne State University
- People needed
- 60
- Starts
- 2015-09-01
- Expected to finish
- 2017-05-01
- Last updated by the study team
- 2017-06-02
Who can join
Age: 16 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Wayne State University School of Medicine — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
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