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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT003919-01A2 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | Subjects attend a community based Mindfulness-Based Stress Reduction course. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | 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. | 8 weeks during intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of diabetes self-management | By self report (survey) | At baseline and 0 - 3 weeks after completion of the intervention |
| Measure of perceived stress | By self report (survey) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Whitebird, PhD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Institute for Education and Research | Bloomington | Minnesota | 55425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29064772 | Derived | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| At baseline and 0 - 3 weeks after completion of the intervention |
| Measure of depression | By self report (survey) | At baseline and 0 - 3 weeks after completion of the intervention |
| Measure of self-efficacy | By self report (survey) | At baseline and 0 - 3 weeks after completion of the intervention |
| Measure of quality of life | By self report (survey) | At baseline and 0 - 3 weeks after completion of the intervention |
| patient evaluation of MBSR intervention | 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 | week 12- 15 post baseline measures |
| D004191 |
| Behavioral Disciplines and Activities |