Motivational Interviewing and Cognitive Behavioral Therapy-based Intervention for Cardiovascular Disease Prevention Amongst American Indians With Diabetic and Depressive Symptoms



Status:Completed
Conditions:Depression, Peripheral Vascular Disease, Endocrine, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2013
End Date:December 2015

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Healthy Hearts, Healthy Minds

American Indians (AIs) living in the Northwest have very high rates of diabetes, obesity,
tobacco use, depression, and other risk factors associated with cardiovascular disease.
Depression and diabetes have a pernicious effect on CVD risk and susceptibility. This study
seeks to build upon the success of the 1-month, 5-session motivational interviewing (MI) CVD
prevention component of the həli?dxw Project (aka Healthy Hearts-originally funded under
RFA-HL-06-002; U01 HL HL087322-05). həli?dxw successfully culturally adapted MI for CVD
prevention for AIs, trained AIs to implement the intervention, and conducted a preliminary
feasibility and efficacy trial. Initial results indicated that participants enthusiastically
embraced the MI component of the program; however, observations of the counselors, survey
data, and feedback from participants suggest that depressive symptomatology served as a
barrier to achieving CVD preventive behaviors and desired outcomes; and, that more time and
attention to underlying depressive symptomatology may enhance motivation and CVD prevention
behaviors, particularly among AIs with pre-diabetes and Type 2 diabetes. Building upon solid
preliminary CVD epidemiological data, preliminary acceptability and feasibility of utilizing
an MI approach, and motivated by the need to address elevated depression and diabetes
profiles from the həli?dxw study, the investigators will develop a 3-month, 10-session
MI-based cognitive-behavioral-adherence (MI-CBT-CVD) treatment program to address underlying
depressive symptomatology, activate CVD prevention behaviors, and decrease BMI and CVD risk
behaviors among 50 pre-and recently diagnosed diabetic AIs at risk for CVD. The study
proposes three innovative and significant aims. First, in line with community-based
participatory (CBPR) principles and pre-established indigenous research protocols with the
tribal community, the investigators will conduct formative research to develop the
MI-CBT-CVD intervention. Second, the investigators will conduct a pilot randomized
two-group, single-site waitlist-controlled clinical trial of a 10-session, 3-month MI-based
cognitive-behavioral treatment for CVD prevention (MI-CBT-CVD) among 50 pre-and recently
diagnosed diabetic AI adults with depressive symptomatology and who are also at risk for
CVD. Assessments will be conducted at pre and post intervention and at 6-months (3 month
follow-up). Third, the investigators will disseminate the findings to the tribe as well as
research outlets and prepare an RO1 to conduct a full-scale RCT should the pilot
intervention be efficacious, acceptable to the community, and feasible. The primary
objectives will be to determine the effect of the proposed culturally-grounded behavioral
intervention program on (a) reducing weight as measured by BMI (7-10% reduction in BMI); (b)
decreasing depressive symptomatology; (c) increasing physical activity; (d) decreasing
sedentary activities; (d) increasing healthful food habits; and (e) improving biomedical
outcomes (e.g., blood lipid profiles, glucose, hemoglobin A1C, and blood pressure). The
intervention will be culturally relevant and utilize existing Native resources and personnel
wherever possible.


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
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