Clinical trial NCT02928952: Mindful Stress Reduction in Diabetes Self-management Education for Veterans
Official title: Effects of a Mindfulness Intervention Delivered Within Diabetes Education on Diabetes-related Outcomes in Military Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Mindfulness
Diabetes Distress
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-10-10
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to see if adding Mindfulness training to diabetes education reduces feelings of stress and makes it easier to adhere to healthy behaviors that improve diabetes outcomes (such as hemoglobin A1c).

Detailed description: Background: One million Veterans (25%) who receive health care through Veterans Health Administration (VHA) have diabetes and are therefore responsible for daily diabetes self-management (DSM). DSM is essential for glycemic control and prevention of potentially life threatening and disabling complications such as severe hypoglycemia, kidney failure, acute coronary syndrome and stroke. Importantly, 40% of individuals with diabetes suffer from diabetes-related distress (DRD) that interferes with their ability to sustain healthy self-management behaviors, and may be particularly problematic for Veterans who are at higher risk for comorbid negative emotional states such as depression and post-traumatic stress disorder.

Diabetes self-management education (DSME) has traditionally contained little content or skill-building directly related to stress management, leaving this critical component of diabetes self-management largely unaddressed in DSME. In the investigators' pilot work, the investigators have developed a brief stress management intervention known as Mind-STRIDE, which contains mindfulness training and home practice and is easily integrated into existing DSME. While the investigators have previously demonstrated the feasibility, patient acceptability, and initial efficacy of Mind-STRIDE, its effects on diabetes-related psychological and physiological patient outcomes remain unknown. There is, therefore, a critical need to determine the efficacy of this targeted mindfulness intervention for improving DRD, diabetes self-efficacy, DSM behaviors, and metabolic control of Veterans with diabetes in order to offer comprehensive, evidence-based DSME that improves Veteran-centric diabetes outcomes.

Objectives: The objectives of this study are to determine the efficacy of Mind-STRIDE for improving DRD, diabetes self-efficacy, DSM, and metabolic control, and to characterize distinctive Veteran experiences with DRD and Mind-STRIDE.

Methods: To achieve these objectives, the investigators will conduct a randomized controlled trial of 126 Veterans at a large VA medical center in southwest PA. Participants will be assigned to one of two study conditions: an experimental group that receives routine diabetes education plus Mind-STRIDE, or to a usual care group that receives diabetes education alone. DRD, diabetes self-efficacy, and DSM will be assessed using self-report questionnaires. Metabolic control (Hemoglobin A1c) will be assessed using standard laboratory procedures. Data will be collected at baseline, 12-weeks, and 24-weeks, and will be analyzed using mixed-effects models. Telephone interviews will be conducted at 15-weeks post-intervention in a subset of participants from the experimental group, and will be analyzed using modified Grounded Theory methods. Quantitative and qualitative findings will be compared and interpreted using Convergent Parallel Design.

Status: Assessments were completed 4/09/2020.

Eligibility criteria: Inclusion Criteria:

* Referral to DSME class at VA Pittsburgh Healthcare System University Drive Campus (VAPHS UD)
* Diagnosis of type 1 or type 2 diabetes
* Hemoglobin A1C \>7.0%
* Problem Areas in "Diabetes Scale (PAID) -5" score =/ \>3 or "Diabetes Distress Scale -2" =/\>2 score indicating the presence of Diabetes-related Distress

Exclusion Criteria:

* Documented cognitive impairment that would interfere with the ability to comprehend the informed consent and actively participate in the study
* Previous attendance of VA DSME class within the past 12 months
* Currently active mindfulness practice

Primary outcomes:
measure: Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress)
timeFrame: baseline, 12 weeks and 24 weeks
Secondary outcomes:
measure: Diabetes Self-efficacy Scale (DSES)
timeFrame: baseline, 12 weeks and 24 weeks
measure: Hemoglobin A1c (A1C)
timeFrame: baseline, 12 weeks and 24 weeks
measure: Mindfulness Attention and Awareness Scale (MAAS)
timeFrame: baseline, 12 weeks and 24 weeks
measure: Body Weight
timeFrame: baseline, 12 weeks and 24 weeks
measure: Blood Pressure
timeFrame: baseline, 12 weeks and 24 weeks
measure: Patient Health Questionnaire (PHQ8)
timeFrame: baseline, 12 weeks and 24 weeks
measure: PTSD Checklist- Civilian Version (PCL-C)
timeFrame: baseline, 12 weeks and 24 weeks
measure: Summary of Diabetes Self-Care Activities (SDSCA), General Diet
timeFrame: baseline, 12 weeks and 24 weeks
measure: Summary of Diabetes Self-Care Activities (SDSCA), Specific Diet
timeFrame: baseline, 12 weeks and 24 weeks
measure: Summary of Diabetes Self-Care Activities (SDSCA) Space Carbohydrates
timeFrame: baseline, 12 weeks and 24 weeks
measure: Summary of Diabetes Self-Care Activities (SDSCA)- Exercise
timeFrame: baseline, 12 weeks, 24 weeks
measure: Summary of Diabetes Self-Care Activities (SDSCA)- - Footcare
timeFrame: baseline, 12 weeks, 24 weeks
measure: Summary of Diabetes Self-Care Activities (SDSCA)- Blood Glucose Testing
timeFrame: baseline, 12 weeks, 24 weeks
measure: Summary of Diabetes Self-Care Activities (SDSCA)- - Smoking
timeFrame: baseline,12 weeks, 24 weeks
measure: Summary of Diabetes Self-Care Activities (SDSCA)- - Medication Adherence
timeFrame: baseline, 12 weeks, 24 weeks
Other outcomes:
measure: Change in 6-item PROMIS Short Form v1.0 Pain Interference 6 b
timeFrame: baseline, 12 weeks and 24 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: baseline, 12 weeks and 24 weeks
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Monica M. DiNardo, PhD ARNP CDE
role: PRINCIPAL_INVESTIGATOR
References:
citation: DiNardo MM, Greco C, Phares AD, Beyer NM, Youk AO, Obrosky DS, Morone NE, Owen JE, Saba SK, Suss SJ, Siminerio L. Effects of an integrated mindfulness intervention for veterans with diabetes distress: a randomized controlled trial. BMJ Open Diabetes Res Care. 2022 Mar;10(2):e002631. doi: 10.1136/bmjdrc-2021-002631.