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Diabetes MellitusMind-STRIDENCT02928952

Mindful Stress Reduction in Diabetes Self-management Education for Veterans

A study testing Mind-STRIDE in people with Diabetes Mellitus, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
Mind-STRIDE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteUnited States
Study dates
1 Nov 2016to 9 Apr 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

Official title: Effects of a Mindfulness Intervention Delivered Within Diabetes Education on Diabetes-related Outcomes in Military Veterans

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).

Read the 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.

Being tested
Mind-STRIDE
Keywords
Mindfulness, Diabetes Distress
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mind-STRIDEBehavioural

    Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education

Study groups in NCT02928952
Study groupRoleWhat they receive
Diabetes Self Management Education (DSME) + Mind-STRIDEExperimentalWill receive routine diabetes self-management education + the Mind-STRIDE intervention
Receives: Behavioral: Mind-STRIDE
DSME aloneNo interventionUsual care control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress)

    A 20-item psychometrically validated self-report questionnaire on a 5 point Likert scale (0= not problem; 4= a serious problem). The scores are summed and multiplied by 1.25. Minimum value = 0; Maximum value = 100. Higher scores denote higher levels of diabetes related distress. The cutoff for significant distress is 33; a score of 40 is consistent with diabetes burn-out.

    Measured: baseline, 12 weeks and 24 weeks

Secondary outcomes (15)
  1. Diabetes Self-efficacy Scale (DSES)

    An 8-item psychometrically validated self-report questionnaire on a 10- point Likert Scale (1= Not confident at all; 10 = Totally confident). This scale measures diabetes self efficacy, a critical pathway to improved self-management that refers to an individual's confidence in their ability to perform key diabetes self-management behaviors. Scores are derived as the mean of the 8 questions. Minimum score =1; Maximum Score = 10. Higher scores denote higher diabetes self-efficacy.

    Measured: baseline, 12 weeks and 24 weeks

  2. Hemoglobin A1c (A1C)

    A blood test that measures the percentage of glycated hemoglobin in red blood cells as a means of estimating the average blood sugar concentrations for the preceding two to three months. Lower percentage denote better blood glucose levels and may range from 4.5% in persons without diabetes t0 >15% in persons with poorly managed hyperglycemia. . An A1C <7% has been associated with prevention of diabetes complications. A1C>9% denotes chronic,severe blood glucose elevation. All tests were performed at VAPHS according to National Glyco-hemoglobin Standardization Program-approved methods.

    Measured: baseline, 12 weeks and 24 weeks

  3. Mindfulness Attention and Awareness Scale (MAAS)

    A 15-item psychometrically validated questionnaire on a 6-point Likert scale (1=Almost Always and 6= Never) The scale is scored by computing the mean of the 15 items. (Minimum score = 1; maximum score = 6). Higher scores reflect higher levels of dispositional (trait) mindfulness. Average score in the general US population is 4.22. Mindfulness is a mental state achieved by focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations.

    Measured: baseline, 12 weeks and 24 weeks

  4. Body Weight

    Weight in pounds

    Measured: baseline, 12 weeks and 24 weeks

  5. Blood Pressure

    Change in mean arterial blood pressure, calculated as blood pressure + 2 (diastolic blood pressure) divided by 3.

    Measured: baseline, 12 weeks and 24 weeks

  6. Patient Health Questionnaire (PHQ8)

    The Patient Health Questionnaire (PHQ-8) is a standardized, validated scale that assesses 8 key symptoms of depression experienced over the prior two weeks on a 4-point Likert scale (0=not at all; 3= nearly every day). It is the same as the PHQ-9, without the question regarding suicidal ideation. Score is the sum of the 8 items (Minimum value =0; Maximum= 24). A score of 10 or greater is considered major depression, 20 or more is severe major depression.

    Measured: baseline, 12 weeks and 24 weeks

  7. PTSD Checklist- Civilian Version (PCL-C)

    The Abbreviated PCL-C is a validated 6-item civilian version of the PTSD check- list designed for use in general medical settings to assess symptoms of PTSD using a 5-point Likert scale. Scores reflect how much the participant has been bothered by specific PTSD symptoms during the past month. (0= "not at all; 4= "extremely") .Scores are summed. (Minimum value =0; maximum values = 24). Scores >14 are suggestive of PTSD, with higher scores reflecting greater PTSD symptoms.

    Measured: baseline, 12 weeks and 24 weeks

  8. Summary of Diabetes Self-Care Activities (SDSCA), General Diet

    A 2-item subscale of the psychometrically validated SDSCA that measures the frequency of general dietary behaviors each day over the past 7-days and number of days per week over the past month (0= no days; 7 = 7 days). Scores = mean number of days per week ( Minimum score =0; maximum score = 7) . Higher scores denote healthier dietary behaviors.

    Measured: baseline, 12 weeks and 24 weeks

  9. Summary of Diabetes Self-Care Activities (SDSCA), Specific Diet

    A 2-item subscale of the psychometrically validated SDSCA that measures the frequency of eating fruits and vegetables and high fat foods each day over the past 7-days. Minimum maximum values = (0= no days; 7 = 7 days). 1 item is scored as mean number of days (Minimum score =0; maximum score = 7), while the 2nd item is summed and reversed (0= 7days; 7= 0 days). The scores for the two items are summed for the subscale score (Minimum score=0; maximum score =7) Higher scores denote healthier dietary behaviors.

    Each subscale of the SDSCA is scored separately, without a calculated composite score.

    Measured: baseline, 12 weeks and 24 weeks

  10. Summary of Diabetes Self-Care Activities (SDSCA) Space Carbohydrates

    One item from the SDSCA that assesses the number of days over the past 7-days in which the participant spaced carbohydrates evenly throughout the day. Minimum score 0; maximum score 7. Higher scores denote healthier dietary behaviors.

    Measured: baseline, 12 weeks and 24 weeks

  11. Summary of Diabetes Self-Care Activities (SDSCA)- Exercise

    A 2-item subscale of the SDSCA that measures the number of days over the past 7-days on which the participant engaged in physical activity . Score = mean score of days over the past 7 days (Min.=1; Max.=7). Higher scores denote healthier exercise behaviors.

    Each SDSCA subscale scored separately.

    Measured: baseline, 12 weeks, 24 weeks

  12. Summary of Diabetes Self-Care Activities (SDSCA)- - Footcare

    A 2-item subscale of the SDSCA that measures the number of days the participant 1) inspected their feet and 2) inspected the inside of their shoes over the past 7-days. Score = mean number of days (Min=0; max=7). Higher scores denote healthier footcare behaviors.

    Measured: baseline, 12 weeks, 24 weeks

  13. Summary of Diabetes Self-Care Activities (SDSCA)- Blood Glucose Testing

    A 2-item subscale of the SDSCA that measures 1) the number of days on which the participant tested their blood glucose over the past 7 days and 2) the number of days on which they tested their blood glucose according to the number of times recommended by their health care provider over the past 7-days. Scores= mean number of days per week. Minimum score is 0 Maximum score is 7.Higher scores denote healthier self-monitoring behaviors.

    Each SDSCA subscale scored separately

    Measured: baseline, 12 weeks, 24 weeks

  14. Summary of Diabetes Self-Care Activities (SDSCA)- - Smoking

    A 2-item subscale of the SDSCA that measures 1) whether the participant smoked even a puff of a cigarette in the past 7 days (0=no; 1= yes) and 2) if so, the number of cigarettes smoked on an average day. The scores are summed. Minimum score =0, maximum score = >40. Lower scores denote healthier smoking behaviors.

    Measured: baseline,12 weeks, 24 weeks

  15. Summary of Diabetes Self-Care Activities (SDSCA)- - Medication Adherence

    A 2-item subscale of the SDCSA that measures the frequency of 1) taking prescribed insulin and 2)prescribed number of diabetes pills each day over the past 7-days. Scores from the 2 items are summed. Minimum score =0; maximum score = 7). Higher scores denote greater adherence to diabetes medications. Participants entered N/A if they were not prescribed insulin or diabetes pills.

    Each subscale of the SDSCA is scored independently with no calculated composite score.

    Measured: baseline, 12 weeks, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2016 (estimated)
  2. Study start1 Nov 2016
  3. Primary completion9 Apr 2020
  4. Study completion9 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02928952
Sponsor's protocol ID
NRI 15-150
Acronym
Mind-STRIDE
Status last verified
May 2021
First submitted
4 Oct 2016
Last updated
28 May 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There are currently no plans to share Individual Participant Data (IPD).

Publications

  • 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.

    PubMed 35346971

Questions about this trial

What is this clinical trial studying?

A study testing Mind-STRIDE in people with Diabetes Mellitus, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress) (time frame: baseline, 12 weeks and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02928952, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.

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