Managing Diabetes Mindfully Study

Study Overview
=================
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.

Official Title
-----------------
Managing Diabetes Mindfully Study

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-Based Stress Reduction (MBSR)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Stress Reduction<br>Subjects attend a community based Mindfulness-Based Stress Reduction course. | Behavioral: Mindfulness-Based Stress Reduction (MBSR)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mindfulness-Based Stress Reduction, Diabetes Management, Stress Reduction, Diabetes Testing