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Decreasing Stress in Type 2 Diabetes (STRESST2D)

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ClinicalTrials.gov Identifier: NCT04016415
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
Rowan University
Penn State University
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 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, 8-weeks, 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 a RCT to determine the effects of a 6-month MBSR intervention compared to health education on glucose control in 290 patients with uncontrolled T2DM. The primary outcome will be hemoglobin A1c (HbA1c), a measure of average glucose levels 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 month 6. Additionally, we will look at fasting glucose and glucose variability as they are also linked with adverse outcomes; 2) To determine the effects of MBSR versus health education control on psychosocial, behavioral and physiological mechanisms potentially mediating its glucose-lowering effects in patients 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 longterm 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 MBSR intervention (6 months instead of the standard 8 weeks) versus health education (active control) on glucose control in 290 patients with uncontrolled T2DM
Masking: Triple (Care Provider, 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 health education instructors and the study personnel who schedule the classes, videotape 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 : September 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mindfulness Based Stress Reduction
Subjects randomized to 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.
Behavioral: Mindfulness Based Stress Reduction
Mindfulness practice by subjects is the intervention, control group will be stress management and health education.

Placebo Comparator: Stress Management Education
The study will use a health education active control group. To control for instructor attention and group support, the health education group will receive the same number and duration of sessions, and also have two co-teachers per session as in the MBSR group. The health education sessions will be taught by masters or doctoral-level professionals with training in dietetics. Topics to be covered include basic pathophysiology, diagnosis, symptoms, complications, treatments, preventative measures, and diet and physical activity for T2DM. The study will follow the Health Enhancement Program Guidelines to optimize our control condition and increase its appeal to participants. The control group will follow a manualized intervention and have regular supervision and facilitator buy-in just like the MBSR group. The control group will be identical to the MBSR group, but will not involve any mindfulness.
Behavioral: Stress Management Education
The study will use a health education active control group. To control for instructor attention and group support, the health education group will receive the same number and duration of sessions, and also have two co-teachers per session as in the MBSR group. The health education sessions will be taught by masters or doctoral-level professionals with training in dietetics. Topics to be covered include basic pathophysiology, diagnosis, symptoms, complications, treatments, preventative measures, and diet and physical activity for T2DM. The study will follow the Health Enhancement Program Guidelines to optimize our control condition and increase its appeal to participants. The control group will follow a manualized intervention and have regular supervision and facilitator buy-in just like the MBSR group. The control group will be identical to the MBSR group, but will not involve any mindfulness.
Other Name: Active Control




Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 12 months ]
    The primary outcome will be hemoglobin A1c (HbA1c), a measure of average glucose control 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 month 6, and that this will be sustained at 12 months. We will also look at the 8-week 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%.


Secondary Outcome Measures :
  1. Diabetes Related Distress [ Time Frame: 12 months. ]
    The 17-item questionnaire will assess diabetes-related distress. On a scale from a range 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.

  2. Perceived Stress Scale [ Time Frame: 12 months ]
    The 10-item questionnaire will assess subjective stress. On a scale from a range of 0 to 4, where 0 = Never and 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

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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:

  • Diagnosed with type 2 diabetes for at least one year
  • Hemoglobin A1c > or equal to 8%
  • High subjective stress defined as Perceived Stress Scale -10 score > or equal to 20
  • Available for the interventions sessions
  • Have a smart phone for text messaging
  • Respond to at least 80% of questions sent via text messaging during screening as a 2-day practice run of the EMA Protocol for Naturalistic Repeated Measures of Stress

Exclusion Criteria:

  • Pregnant women
  • Significant untreated active psychopathology such as psychosis or suicidal ideation.
  • Severe untreated depression or anxiety. Those with severe depression or anxiety will be allowed to participate if they are under the care of a mental health specialist as long as they have permission to do so from their mental health specialist and will continue to follow-up with their mental health specialist during the study. Structured Clinical Interviews will be carried out in all potential subjects to screen for psychiatric conditions.
  • History of an inpatient admission for psychiatric disorder within the past two years
  • Active alcohol or drug abuse
  • Inability to read, write or speak English
  • Inability to commit to the intervention and follow-up
  • Current enrollment in a stress reduction program
  • Mindfulness practice within the past 6 months (regular formal practice at least once a week)
  • Acupuncture within the past 30 days
  • Current enrollment in other investigative studies

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
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Rowan University
Penn State University
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 and Obstertics and Gynecology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04016415     History of Changes
Other Study ID Numbers: 10532
1R01DK119379-01 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases