Diabetes Mellitus
Conditions
Keywords
Mindfulness-Based Stress Reduction, Diabetes Management, Stress Reduction, Diabetes Testing
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.
Interventions
BEHAVIORALMindfulness-Based Stress Reduction (MBSR)
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.
Sponsors
HealthPartners Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C Blood Test | Baseline and 12-15 weeks from start of intervention period | This HbA1C blood test will be compared to a qualifying HbA1C blood test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 8 weeks during intervention | Subjects will self-administer blood pressure testing with a wrist blood pressure cuff and a Daily Log provided to the subject and record results during the intervention period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measure of depression | At baseline and 0 - 3 weeks after completion of the intervention | By self report (survey) |
| Measure of self-efficacy | At baseline and 0 - 3 weeks after completion of the intervention | By self report (survey) |
| Measures of diabetes self-management | At baseline and 0 - 3 weeks after completion of the intervention | By self report (survey) |
| patient evaluation of MBSR intervention | week 12- 15 post baseline measures | semi-structured telephone interviews with subjects evaluating their perception of the value of the intervention on their overall diabetes management; their satisfaction with the intervention; and their perception of the intervention impact on their quality of life |
| Measure of quality of life | At baseline and 0 - 3 weeks after completion of the intervention | By self report (survey) |
| Measure of perceived stress | At baseline and 0 - 3 weeks after completion of the intervention | By self report (survey) |
Countries
United States
Outcome results
None listed