Motivational Interviewing and Cognitive Behavioral Therapy-based Intervention for Cardiovascular Disease Prevention Amongst American Indians With Diabetic and Depressive Symptoms
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ClinicalTrials.gov Identifier: NCT01892124 |
Recruitment Status
:
Completed
First Posted
: July 3, 2013
Last Update Posted
: December 15, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Diseases Diabetes Mellitus, Type 2 Depression Dysthymic Disorder | Behavioral: Motivational Interviewing/Cognitive Behavioral-based Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Healthy Hearts, Healthy Minds |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Motivational Interviewing/Cognitive Behavioral-based Therapy
Receives an immediate weekly 10 session intervention based on a culturally-adapted, motivational interviewing and Cognitive Behavioral Therapy grounded protocol.
|
Behavioral: Motivational Interviewing/Cognitive Behavioral-based Therapy |
Experimental: Wait-List Control
Receives a weekly 10 session intervention based on a culturally-adapted, motivational interviewing and Cognitive Behavioral Therapy grounded protocol after a three month, no-intervention waiting period.
|
Behavioral: Motivational Interviewing/Cognitive Behavioral-based Therapy |
- Change in Body Mass Index [ Time Frame: Assessed at baseline, 3 month, and 6 month timepoints ]The investigators will compare changes in body mass index between the wait-list control group and the immediate intervention group, and also for each individual over time.
- Changes in Depressive Symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Assessed at baseline, 3 month, and 6 month timepoints ]The investigators will compare changes in depressive symptoms as measured by the CES-D 10-item scale between the wait-list control group and the immediate intervention group, and also for each individual over time.
- Changes in Blood Lipids [ Time Frame: Assessed at baseline, 3 month, and 6 month timepoints ]The investigators will compare changes in mg/dL of blood lipids (Total cholesterol, HDL-C, LDL-C, triglycerides) between the wait-list control group and the immediate intervention group, and also for each individual over time.
- Changes in Blood Glucose [ Time Frame: Assessed at baseline, 3 month, and 6 month timepoints ]The investigators will compare changes in mg/dL blood glucose between the wait-list control group and the immediate intervention group, and also for each individual over time.
- Changes in Hemoglobin A1c [ Time Frame: Assessed at baseline, 3 month, and 6 month timepoints ]The investigators will compare changes in percent hemoglobin A1c between the wait-list control group and the immediate intervention group, and also for each individual over time.
- Changes in Blood Pressure [ Time Frame: Assessed at baseline, 3 month, and 6 month timepoints ]The investigators will compare changes in mmHg blood pressure levels between the wait-list control group and the immediate intervention group, and also for each individual over time.
- Changes in Physical Activity [ Time Frame: Assessed at baseline, 3 month, and 6 month timepoints ]The investigators will compare changes in physical activity levels between the wait-list control group and the immediate intervention group, and also for each individual over time.
- Changes in Sedentary Activity [ Time Frame: Assessed at baseline, 3 month, and 6 month timepoints ]The investigators will compare changes in sedentary activity levels between the wait-list control group and the immediate intervention group, and also for each individual over time.
- Changes in Food Habits [ Time Frame: Assessed at baseline, 3 month, and 6 month timepoints ]The investigators will compare changes in food habits between the wait-list control group and the immediate intervention group, and also for each individual over time.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be 18 years of age or older
- Be an American Indian/Alaska Native
- Currently reside on or within 20 miles of the Tribal reservation boundary
- Have a Body Mass Index > 25
- Have a PSS (10 item) score > 15
- Be pre-diabetic for Type 2 diabetes (via self-report, health provider referral, or previous glucose reading or hemoglobin A1c reading indicating pre-diabetes within the past 12 months) or have been diagnosed as having Type 2 diabetes
- If a woman, not currently pregnant
Exclusion Criteria:
- Referred to their physician for approval of participation during the baseline assessment process and the physician does not give approval or the participant refused to follow-up on the referral
- Unstable or exhibits serious psychiatric symptoms as determined by project's tribal mental health specialist

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892124
United States, Washington | |
University of Washington, Indigenous Wellness Research Institute | |
Seattle, Washington, United States, 98105 |
Principal Investigator: | Karina L Walters, MSW, PhD | University of Washington | |
Study Director: | Rachelle McCarty, ND, MPH | University of Washington |
Additional Information:
Publications:
Responsible Party: | Karina Walters, Professor, School of Social Work; Director, Indigenous Wellness Research Institute, University of Washington |
ClinicalTrials.gov Identifier: | NCT01892124 History of Changes |
Other Study ID Numbers: |
44890-G P60MD006909 ( U.S. NIH Grant/Contract ) |
First Posted: | July 3, 2013 Key Record Dates |
Last Update Posted: | December 15, 2015 |
Last Verified: | December 2015 |
Keywords provided by Karina Walters, University of Washington:
Motivational Interviewing Cognitive Therapy Community-Based Participatory Research Indians, North American |
Additional relevant MeSH terms:
Diabetes Mellitus Cardiovascular Diseases Diabetes Mellitus, Type 2 Dysthymic Disorder Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Depressive Disorder Mood Disorders Mental Disorders |