Clinical trial NCT01796834: Managing Diabetes Mindfully Study
Official title: Managing Diabetes Mindfully Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Mindfulness-Based Stress Reduction
Diabetes Management
Stress Reduction
Diabetes Testing
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Primary Objective: Evaluate the feasibility of conducting a trial of a MBSR program for patients with diabetes on measures of HbA1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life. Feasibility will be assessed via: a) the interest of patients in taking part in an MBSR program; c) the effectiveness of strategies for recruiting patients with diabetes into the study; d) rates of participant compliance with the MBSR; and, e) patient compliance with the program evaluation plan.

Estimate the effect of a MBSR program for patients with diabetes. 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.

Secondary Objective: To explore the experience of people with diabetes who participate in an MBSR course through the use of semi-structured interviews.

Eligibility criteria: Inclusion Criteria:

* 18-80 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: HbA1C Blood Test
timeFrame: Baseline and 12-15 weeks from start of intervention period
Secondary outcomes:
measure: Blood Pressure
timeFrame: 8 weeks during intervention
Other outcomes:
measure: Measures of diabetes self-management
timeFrame: At baseline and 0 - 3 weeks after completion of the intervention
measure: Measure of perceived stress
timeFrame: At baseline and 0 - 3 weeks after completion of the intervention
measure: Measure of depression
timeFrame: At baseline and 0 - 3 weeks after completion of the intervention
measure: Measure of self-efficacy
timeFrame: At baseline and 0 - 3 weeks after completion of the intervention
measure: Measure of quality of life
timeFrame: At baseline and 0 - 3 weeks after completion of the intervention
measure: patient evaluation of MBSR intervention
timeFrame: week 12- 15 post baseline measures
Locations:
city: Bloomington
country: United States
facility: HealthPartners Institute for Education and Research
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Robin Whitebird, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.