Reducing Stress in Adolescents and Young Adults With Type 1 Diabetes to Improve Diabetes Care

Type 1 Diabetes Clinical Trial

— T1D  

Official title:

Reducing Stress in Adolescents and Young Adults With T1D to Improve Diabetes Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760303
• Other study ID #: 066115B3E
• Secondary ID: R01DK059067
• Status: Completed
• Phase: N/A
• First received: April 28, 2016
• Last updated: May 31, 2017
• Start date: September 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Wayne State University School of Medicine	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Control	Hemoglobin A1c (HbA1c)	Change from Baseline at 3 months, Change from Baseline at 6 months
Secondary	Regimen Adherence (objective)	Frequency of Glucose Meter Testing	Change from Baseline at 3 months, Change from Baseline at 6 months
Secondary	Regimen Adherence (daily diary)	24 Hour Recall of Diabetes Adherence Behavior	Change from Baseline at 3 months, Change from Baseline at 6 months
Secondary	Regimen Adherence (self-reported)	Diabetes Management Scale (DMS)	Change from Baseline at 3 months, Change from Baseline at 6 months
Secondary	Psychological Stress (general)	Perceived Stress Scale (PSS)	Change from Baseline at 3 months, Change from Baseline at 6 months
Secondary	Psychological Stress (diabetes-related)	Diabetes Stress Questionnaire (DSQ)	Change from Baseline at 3 months, Change from Baseline at 6 months
Secondary	Psychological Stress (attitudes)	Hassles and Uplifts Scale	Change from Baseline at 3 months, Change from Baseline at 6 months
Secondary	Diabetes Quality of Life	Diabetes Quality of Life Scale	Change from Baseline at 3 months, Change from Baseline at 6 months