Clinical trial NCT02760303: Reducing Stress in Adolescents and Young Adults With Type 1 Diabetes to Improve Diabetes Care
Official title: Reducing Stress in Adolescents and Young Adults With T1D to Improve Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: insulin dependent diabetes mellitus
adolescents and young adults
stress reduction
metabolic control
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic Control
timeFrame: Change from Baseline at 3 months, Change from Baseline at 6 months
Secondary outcomes:
measure: Regimen Adherence (objective)
timeFrame: Change from Baseline at 3 months, Change from Baseline at 6 months
measure: Regimen Adherence (daily diary)
timeFrame: Change from Baseline at 3 months, Change from Baseline at 6 months
measure: Regimen Adherence (self-reported)
timeFrame: Change from Baseline at 3 months, Change from Baseline at 6 months
measure: Psychological Stress (general)
timeFrame: Change from Baseline at 3 months, Change from Baseline at 6 months
measure: Psychological Stress (diabetes-related)
timeFrame: Change from Baseline at 3 months, Change from Baseline at 6 months
measure: Psychological Stress (attitudes)
timeFrame: Change from Baseline at 3 months, Change from Baseline at 6 months
measure: Diabetes Quality of Life
timeFrame: Change from Baseline at 3 months, Change from Baseline at 6 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University School of Medicine
state: Michigan
Study officials:
affiliation: Wayne State University
name: Deborah Ellis, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: