Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatment stress reduction
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date August 2015
End date October 2016
Trial size 51 participants
Trial identifier NCT02760303, 066115B3E

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Utilizes activities to understand how thoughts affect emotions and behaviors, the application of these activities to current stressors, and strategies to apply theses new skills to future stressors.
stress reduction
Participants will attend group therapy sessions, once a week for 9 weeks.
(Experimental)
Treatment focuses on the instruction and practice of mindfulness techniques, such as meditation and yoga, and the application of these practices to everyday activities.
stress reduction
Participants will attend group therapy sessions, once a week for 9 weeks.
(Active Comparator)
Participants will receive diabetes education via a support group format.
stress reduction
Participants will attend group therapy sessions, once a week for 9 weeks.

Primary Outcomes

Measure
Metabolic Control: Hemoglobin A1c (HbA1c)
time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Regimen Adherence: Frequency of Glucose Meter Testing
time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Regimen Adherence: 24 Hour Recall of Diabetes Adherence Behavior
time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Regimen Adherence: Diabetes Management Scale (DMS)
time frame: Change from Baseline at 3 months, Change from Baseline at 6 months

Secondary Outcomes

Measure
Stress: Perceived Stress Scale
time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Stress: Diabetes Stress Questionnaire
time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Depression: The Center for Epidemiologic Studies Depression Scale
time frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Quality of Life: Diabetes Quality of Life Scale
time frame: Change from Baseline at 3 months, Change from Baseline at 6 months

Eligibility Criteria

Male or female participants from 16 years up to 20 years old.

Inclusion Criteria: 1. Aged 16 years, 0 months to 20 years, 11 months 2. Diagnosed with type 1 diabetes for at least six months 3. Poor metabolic control as defined by HbA1c >=9% Exclusion Criteria: 1. Mental health conditions that might compromise data integrity (e.g., developmental delay, psychosis, suicidality) 2. Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis) 3. Inability to speak or read English

Additional Information

Official title Reducing Stress in Adolescents and Young Adults With T1D to Improve Diabetes Care
Principal investigator Deborah Ellis, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).