NCT01796834

Brief Summary

To evaluate the feasibility of conducting a trial of a mindfulness-based stress reduction (MBSR) program for patients with diabetes (DM) on measures of HbA1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life; and to estimate the effect of a MBSR program for patients with DM. It is expected that MBSR program participants will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and standardized measures of diabetes self-management, perceived stress, depression, self-efficacy, and quality-of-life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
Last Updated

August 14, 2023

Status Verified

February 1, 2013

Enrollment Period

5 months

First QC Date

February 19, 2013

Last Update Submit

August 10, 2023

Conditions

Diabetes Mellitus

Keywords

Mindfulness-Based Stress ReductionDiabetes ManagementStress ReductionDiabetes Testing

Outcome Measures

Primary Outcomes (1)

  • HbA1C Blood Test

    This HbA1C blood test will be compared to a qualifying HbA1C blood test.

    Baseline and 12-15 weeks from start of intervention period

Secondary Outcomes (1)

  • Blood Pressure

    8 weeks during intervention

Other Outcomes (6)

  • Measures of diabetes self-management

    At baseline and 0 - 3 weeks after completion of the intervention

  • Measure of perceived stress

    At baseline and 0 - 3 weeks after completion of the intervention

  • Measure of depression

    At baseline and 0 - 3 weeks after completion of the intervention

  • +3 more other outcomes

Study Arms (1)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

Subjects attend a community based Mindfulness-Based Stress Reduction course.

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Interventions

Mindfulness-Based Stress Reduction (MBSR)BEHAVIORAL

An 8-9 week MBSR course led by an experienced instructor in a group format. Participants learn mindfulness meditation techniques and simple yoga exercises. Subjects receive four phone support calls.

Mindfulness-Based Stress Reduction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • English speaking
  • have type 2 diabetes, with 2 HbA1C values \>8 in prior 16 months
  • HbA1C value of \>8 within 3 months of intervention start
  • able to read course materials
  • mentally intact with no history of mental illness or major depression
  • reachable by phone (for phone support component)
  • able to attend weekly classes
  • willing to provide written informed consent

You may not qualify if:

  • completed formal training in other mind body practices such as meditation, yoga, or tai chi within the prior year or currently have a regular ongoing practice in this area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Institute for Education and Research

Bloomington, Minnesota, 55425, United States

Location

Related Publications (1)

  • Whitebird RR, Kreitzer MJ, Vazquez-Benitez G, Enstad CJ. Reducing diabetes distress and improving self-management with mindfulness. Soc Work Health Care. 2018 Jan;57(1):48-65. doi: 10.1080/00981389.2017.1388898. Epub 2017 Oct 24.

    PMID: 29064772DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Robin Whitebird, PhD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2013

First Posted

February 22, 2013

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 14, 2023

Record last verified: 2013-02

Locations

US(1)