Reducing Stress in Adolescents and Young Adults With Type 1 Diabetes to Improve Diabetes Care (T1D)

May 31, 2017 updated by: Deborah Ellis, Ph.D., Wayne State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Wayne State University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cognitive Behavioral Therapy
Hains' adaptation of cognitive behavioral therapy for adolescents and young adults with type 1 diabetes
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.
Other Names:
  • CBT
EXPERIMENTAL: Mindfulness Based Stress Reduction
Sabinga's adaptation of Mindfulness Based Stress Reduction for adolescents and young adults with type 1 diabetes
Behavioral: 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.
Other Names:
  • MBSR
ACTIVE_COMPARATOR: Diabetes Support and Education
Investigator developed peer support group and diabetes education
Behavioral: 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).
Other Names:
  • DSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Control
Time Frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Hemoglobin A1c (HbA1c)
Change from Baseline at 3 months, Change from Baseline at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regimen Adherence (objective)
Time Frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Frequency of Glucose Meter Testing
Change from Baseline at 3 months, Change from Baseline at 6 months
Regimen Adherence (daily diary)
Time Frame: Change from Baseline at 3 months, Change from Baseline at 6 months
24 Hour Recall of Diabetes Adherence Behavior
Change from Baseline at 3 months, Change from Baseline at 6 months
Regimen Adherence (self-reported)
Time Frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Diabetes Management Scale (DMS)
Change from Baseline at 3 months, Change from Baseline at 6 months
Psychological Stress (general)
Time Frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Perceived Stress Scale (PSS)
Change from Baseline at 3 months, Change from Baseline at 6 months
Psychological Stress (diabetes-related)
Time Frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Diabetes Stress Questionnaire (DSQ)
Change from Baseline at 3 months, Change from Baseline at 6 months
Psychological Stress (attitudes)
Time Frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Hassles and Uplifts Scale
Change from Baseline at 3 months, Change from Baseline at 6 months
Diabetes Quality of Life
Time Frame: Change from Baseline at 3 months, Change from Baseline at 6 months
Diabetes Quality of Life Scale
Change from Baseline at 3 months, Change from Baseline at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Deborah Ellis, Ph.D, Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (ESTIMATE)

May 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 066115B3E
  • R01DK059067 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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