Decreasing Stress in Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— De-Stress  

Official title:

Decreasing Stress in Diabetes: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04016415
• Other study ID #: 10532
• Secondary ID: 5R01DK119379
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: August 2023
• Source: Milton S. Hershey Medical Center
• Contact: Sundal Ghori or John Graybeal
• Phone: 717-531-8395
• Email: dstudy[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Georgetown University, 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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c from Baseline to 6 months	Hemoglobin A1c (HbA1c) is a measure of average glucose levels over the past 3 months.	baseline and 6 months
Secondary	Change in Hemoglobin A1c from Baseline to 2 months	Hemoglobin A1c (HbA1c) is a measure of average glucose levels over the past 3 months.	baseline and 2 months
Secondary	Change in Diabetes Distress Scale from Baseline to 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
Secondary	Change in Diabetes Distress Scale from Baseline to 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
Secondary	Change in Perceived Stress Scale-10 from Baseline to 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
Secondary	Change in Perceived Stress Scale-10 from Baseline to 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