Clinical trial NCT04016415: Decreasing Stress in Diabetes
Official title: Decreasing Stress in Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Keywords: Stress, Psychological
Mindfulness
Meditation
Mind-Body Therapies
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institutes of Health (NIH)
name: Rowan University
name: West Chester University of Pennsylvania
name: Georgetown University
First posted: 2019-07-11
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, parallel group two-arm trial that will determine the effects of an online 6-month Mindfulness-based stress reduction (MBSR) intervention compared to Stress Management Education (SME) (active control) on glucose control in at least 290 patients with uncontrolled diabetes. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a randomized controlled trial (RCT) 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 control in adults with uncontrolled type 1 or type 2 diabetes. The study will randomize at least 290 adults with uncontrolled diabetes to a 6-month MBSR intervention or SME control. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing. Outcomes will be assessed at baseline, a follow-up phone call after Class #4, and study visits at 2-months and 6-months.

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 at least 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.

Eligibility criteria: Inclusion Criteria:

1. Men and Women
2. Age 18 years or older
3. Diagnosed with diabetes for at least one year
4. Hemoglobin A1c ≥ 7.5% within 10 weeks and 2 days (72 days) before the start of the study intervention (Orientation session)
5. High Subjective stress defined as Perceived Stress Scale-10 score ≥ 12
6. Available for the intervention sessions with reasonable certainty
7. 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
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, 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.
3. Inpatient admission for psychiatric disorder within the past two years, or ER visit for psychiatric disorder within the past 10 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. Previous participation in a mindfulness-based stress reduction (MBSR) course
8. Pregnant women
9. Have a household member who is currently, or was previously, assigned to study treatment

Primary outcomes:
measure: Change in Hemoglobin A1c from Baseline to 6 months
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change in Hemoglobin A1c from Baseline to 2 months
timeFrame: baseline and 2 months
measure: Change in Diabetes Distress Scale from Baseline to 2 months
timeFrame: baseline and 2 months
measure: Change in Diabetes Distress Scale from Baseline to 6 months
timeFrame: baseline and 6 months
measure: Change in Perceived Stress Scale-10 from Baseline to 2 months
timeFrame: baseline and 2 months
measure: Change in Perceived Stress Scale-10 from Baseline to 6 months
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Nazia T Raja-Khan, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: