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Decreasing Stress in Type 2 Diabetes (DESTRESS-T2D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04016415
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : March 30, 2020
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Penn State University
Rowan University
West Chester University of Pennsylvania
Information provided by (Responsible Party):
Nazia Raja-Khan, Milton S. Hershey Medical Center

Brief Summary:
The purpose of this study is to conduct a randomized controlled trial (RCT) to determine the effects of a 6-month Mindfulness-based stress reduction (MBSR) intervention compared to an active control Stress Management Education (SME) on glucose control in adults with uncontrolled type 2 diabetes (T2DM). The study will randomize 290 adults with uncontrolled T2DM to a 6-month MBSR intervention or SME control. Outcomes will be assessed at baseline, 2-months, 6-months and 1-year.

Condition or disease Intervention/treatment Phase
Stress Diabetes Mellitus, Type 2 Behavioral: Mindfulness Based Stress Reduction Behavioral: Stress Management Education Not Applicable

Detailed Description:
Specific Aims are: 1) To conduct an RCT to determine the effects of a 6-month MBSR intervention compared to an active control Stress Management Education (SME) on glucose control in 290 adults with uncontrolled T2DM. The primary outcome will be hemoglobin A1c (HbA1c), a measure of average glucose levels over the past 3 months. The Investigators 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 month 6, and that this will be sustained at 1 year. The study team will also look at the 2-month HbA1c, however it may be too brief a time period to fully capture the impact of MBSR. A reduction in HbA1c of 0.5% would be expected to reduce the risk of any diabetes-related complication by at least 10%. Additionally, investigators will look at fasting glucose and glucose variability as they are also linked with adverse outcomes; 2) To determine the effects of MBSR compared to SME control on psychosocial, behavioral and physiological mechanisms potentially mediating its glucose-lowering effects in adults with uncontrolled T2DM. Subjective stress, diabetes-related distress and other psychosocial measures will be assessed. Accelerometry will be used to track physical activity. Unannounced phone calls will be used to obtain 24 hour diet recalls. Physiologic measures include serum hsCRP as a marker of chronic inflammation, salivary cortisol to assess the hypothalamic-pituitary-adrenal axis, and salivary α-amylase to assess sympathetic nervous system activity. The proposed study has the potential to transform current standards of care for T2DM by using a novel long-term MBSR intervention as a powerful adjunct intervention for T2DM. MBSR could impact the clinical picture of T2DM 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, parallel group two-arm trial that will determine the effects of a longer Mindfulness-based stress reduction (MBSR) intervention (6 months instead of the standard 8 weeks) compared to Stress Management Education (SME) (active control) on glucose control in 290 patients with uncontrolled T2DM.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The PI, study coordinator, and all study personnel collecting outcomes, will be blinded from the treatment assignments. Only the MBSR and SME instructors and the study personnel who schedule the classes, videorecord the classes, and code the videos will have knowledge of the assignments, and these individuals will not be involved in the collection of outcomes. Subjects will be asked to keep their treatment assignment concealed from study personnel collecting outcomes. However, complete blinding may not be possible given the nature of this study.
Primary Purpose: Treatment
Official Title: Decreasing Stress in Type 2 Diabetes: A Randomized Controlled Trial
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness Based Stress Reduction Behavioral: 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.

Active Comparator: Stress Management Education Behavioral: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Hemoglobin A1c from Baseline to 1 year [ Time Frame: baseline and 1 year ]
    Hemoglobin A1c (HbA1c) is a measure of average glucose levels over the past 3 months.

  2. 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.

  3. 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.

  4. 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.

  5. Change in Diabetes Distress Scale from Baseline to 1 year [ Time Frame: baseline and 1 year ]
    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.

  6. 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.

  7. 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.

  8. Change in Perceived Stress Scale-10 from Baseline to 1 year [ Time Frame: baseline and 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and Women
  2. Age 18 years or older
  3. Diagnosed with type 2 diabetes for at least one year
  4. Hemoglobin A1c ≥ 8% (uncontrolled) within 8 weeks before the start of the study intervention (Orientation session)
  5. High Subjective stress defined as Perceived Stress Scale-10 score ≥ 20
  6. Available for the intervention sessions with reasonable certainty
  7. Have a smartphone with access to the internet and capability to download/install mobile applications for notifications
  8. Must have a Primary Care Provider (PCP)
  9. Must have an accessible/active personal e-mail address or be willing to obtain one for study correspondence

Exclusion Criteria:

  1. Current suicidality
  2. History of, or meets MINI structured interview criteria for, significant psychopathology such as bipolar disorder or psychosis; Those with depression or anxiety will be allowed to participate since they are under the care of a PCP.
  3. Inpatient admission for psychiatric disorder within the past two years, or ER visit for psychiatric disorder within the past 8 weeks
  4. Meets MINI structured interview criteria for Alcohol Use Disorder or Substance Use Disorder (Past 12 months)
  5. Inability to read, write or speak English
  6. Current enrollment in a stress reduction program, or in any other investigative study
  7. Mindfulness practice within the past 6 months (regular formal practice at least once a week)
  8. Previous participation in a mindfulness-based stress reduction (MBSR) course
  9. Pregnant women
  10. Have a household member who is currently, or was previously, assigned to study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016415


Contacts
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Contact: Ellen Stoute, MPH 717-531-0003 ext 286583 estoute@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Ellen Stoute, MPH    717-531-0003 ext 286583    estoute@pennstatehealth.psu.edu   
Contact: Nazia Raja-Khan, M.D.    717-531-8395    nrajakhan@psu.edu   
Principal Investigator: Nazia Raja-Khan, M.D.         
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Penn State University
Rowan University
West Chester University of Pennsylvania
Investigators
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Principal Investigator: Nazia Raja-Khan, MD Milton S. Hershey Medical Center
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Responsible Party: Nazia Raja-Khan, Associate Professor of Medicine, Obstetrics and Gynecology, and Psychiatry and Behavioral Health, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04016415    
Other Study ID Numbers: 10532
1R01DK119379-01 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will make available a complete, cleaned, de-identified copy of the final data set used in conducting the final analyses.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Within 1 year after collecting the final outcome measure
Access Criteria: If requested, the data set will be made available via the Inter-university Consortium for Political and Social Research (ICPSR), of which Pennsylvania State University is a member. Approximately 740 universities, government agencies, and other institutions are members of ICPSR. Names and other personal health identifiers (e.g., zip codes) will be withheld, so that it is not possible for individuals to be individually identified. All other data, including all adherence, outcome and covariate data will be shared in a dataset uploaded into the ICPSR repository. These data would then be shared with all investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes.
URL: http://www.icpsr.umich.edu/icpsrweb/landing.jsp

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nazia Raja-Khan, Milton S. Hershey Medical Center:
Stress, Psychological
Mindfulness
Meditation
Mind-Body Therapies
Diabetes Mellitus, Type 2
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases