- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016415
Decreasing Stress in Diabetes (De-Stress)
Decreasing Stress in Diabetes: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Specific Aims are: 1) To conduct a randomized controlled trial to determine the effects of an online 6-month Mindfulness-Based Stress Reduction (MBSR) intervention compared to an active control Stress Management Education (SME) on glucose levels in 290 adults with uncontrolled type 1 or type 2 diabetes. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing. The primary outcome will be hemoglobin A1c (HbA1c), a measure of the average glucose level over the past 3 months. We hypothesize that between the two groups, there will be a clinically significant 0.5% absolute difference in the mean change in HbA1c from baseline to 6-months. We will also look at the 2-month HbA1c, however it may be too brief a time period to fully capture the impact of MBSR. An absolute reduction in HbA1c of 0.5% would be expected to reduce the risk of any diabetes-related complication by at least 10%. Additionally, we will assess fasting glucose as a secondary outcome as it is linked with adverse health outcomes, and can be lowered with MBSR based on our pilot study; 2) To determine the effects of online MBSR compared to SME control on psychosocial, behavioral and physiological mechanisms potentially mediating the effects of MBSR and/or SME on glucose levels in adults with uncontrolled diabetes. Secondary outcomes include: diabetes-related distress, subjective stress, craving, the impact of COVID-19 on subjects' lives, subject expectancy, dietary intake, physical activity, and serum hsCRP as a marker of chronic inflammation. Adverse Childhood Experiences (ACEs) will be assessed at baseline. It is hypothesized that these measures may mediate the effects of MBSR and/or SME on glucose.
The proposed study has the potential to transform current standards of care for diabetes by using a novel long-term MBSR intervention as a powerful adjunct intervention for diabetes. MBSR could impact the clinical picture of diabetes by empowering patients with skills for strengthening their own internal resources to promote self regulation and adaptive coping and reduce stress reactivity, which are all essential for implementing healthy behaviors and are expected to lead to improved glucose control and reduced risk of diabetes complications. This proposal is relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to conduct research on diabetes to improve people's health and quality of life.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sundal Ghori or John Graybeal
- Phone Number: 717-531-8395
- Email: dstudy@pennstatehealth.psu.edu
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Recruiting
- Penn State College of Medicine, Penn State Milton S Hershey Medical Center
-
Contact:
- Sundal Ghori or John Graybeal
- Phone Number: 717-531-8395
- Email: dstudy@pennstatehealth.psu.edu
-
Contact:
- Nazia T Raja-Khan, M.D., M.S.
- Phone Number: 717-531-8395
- Email: nrajakhan@pennstatehealth.psu.edu
-
Principal Investigator:
- Nazia T Raja-Khan, M.D., M.S.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men and Women
- Age 18 years or older
- Diagnosed with diabetes for at least one year
- Hemoglobin A1c ≥ 7.5% within 10 weeks and 2 days (72 days) before the start of the study intervention (Orientation session)
- High Subjective stress defined as Perceived Stress Scale-10 score ≥ 12
- Available for the intervention sessions with reasonable certainty
- Have a device equipped with internet connection, camera and microphone and willingness to interact with study staff and class instructors virtually/remotely via this platform
- Must have a Primary Care Provider (PCP)
- Must have an accessible/active personal e-mail address or be willing to obtain one for study correspondence
Exclusion Criteria:
- Current suicidality
- History of, or meets MINI structured interview criteria for, bipolar disorder, psychosis, or other significant psychopathology; Those with depression or anxiety will be allowed to participate since they are under the care of a PCP.
- Inpatient admission for psychiatric disorder within the past two years, or ER visit for psychiatric disorder within the past 10 weeks
- Meets MINI structured interview criteria for Alcohol Use Disorder or Substance Use Disorder (Past 12 months)
- Inability to read, write or speak English
- Current enrollment in a stress reduction program, or in any other investigative study
- Previous participation in a mindfulness-based stress reduction (MBSR) course
- Pregnant women
- Have a household member who is currently, or was previously, assigned to study treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Stress Management Education
|
Subjects randomized to Stress Management Education (SME) will receive health education on nutrition (adapted for the type 2 diabetes population), exercise as gentle stretching to match yoga in MBSR, and other general health topics that may be relevant to the type 2 diabetes population such as sleep, time management, etc. Stress Management Education does not have any mindfulness in it.
Stress Management Education was specifically created as a control condition for MBSR studies so it matches MBSR for time, social support, homework, etc.
|
Experimental: Mindfulness Based Stress Reduction
|
Subjects randomized to Mindfulness-Based Stress Reduction (MBSR) will receive the 8-week University of Massachusetts Authorized MBSR curriculum followed by monthly mindfulness boosters in Months 3 to 6.
The University of Massachusetts MBSR curriculum was selected for the intervention, as it is the most standardized and researched mindfulness program that has been shown to reduce psychological distress in various patient populations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hemoglobin A1c from Baseline to 6 months
Time Frame: baseline and 6 months
|
Hemoglobin A1c (HbA1c) is a measure of average glucose levels over the past 3 months.
|
baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hemoglobin A1c from Baseline to 2 months
Time Frame: baseline and 2 months
|
Hemoglobin A1c (HbA1c) is a measure of average glucose levels over the past 3 months.
|
baseline and 2 months
|
Change in Diabetes Distress Scale from Baseline to 2 months
Time Frame: baseline and 2 months
|
The Diabetes Distress Scale (DDS) is a 17-item questionnaire that assesses diabetes-related distress on a scale of 1 to 6, where 1 = Not a Problem to 6 = A Very Serious Problem.
The lowest possible score is 17 and the highest possible score is 102, indicating living with diabetes is a very serious problem.
|
baseline and 2 months
|
Change in Diabetes Distress Scale from Baseline to 6 months
Time Frame: baseline and 6 months
|
The Diabetes Distress Scale (DDS) is a 17-item questionnaire that assesses diabetes-related distress on a scale of 1 to 6, where 1 = Not a Problem to 6 = A Very Serious Problem.
The lowest possible score is 17 and the highest possible score is 102, indicating living with diabetes is a very serious problem.
|
baseline and 6 months
|
Change in Perceived Stress Scale-10 from Baseline to 2 months
Time Frame: baseline and 2 months
|
The Perceived Stress Scale-10 (PSS-10) is a 10-item questionnaire that assesses subjective stress on a scale of 0 to 4, where 0 = Never to 4 =Very Often.
The lowest possible score is 0 and the highest possible score is 40, indicating high levels of subjective stress.
|
baseline and 2 months
|
Change in Perceived Stress Scale-10 from Baseline to 6 months
Time Frame: baseline and 6 months
|
The Perceived Stress Scale-10 (PSS-10) is a 10-item questionnaire that assesses subjective stress on a scale of 0 to 4, where 0 = Never to 4 =Very Often.
The lowest possible score is 0 and the highest possible score is 40, indicating high levels of subjective stress.
|
baseline and 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nazia T Raja-Khan, M.D., M.S., Milton S. Hershey Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10532 (DAIDS ES)
- 5R01DK119379 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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