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

Study Description

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Brief Summary:

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.

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 Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

Other Outcome Measures:

1. 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.
2. 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.
3. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, Washington
University of Washington, Indigenous Wellness Research Institute
Seattle, Washington, United States, 98105

Sponsors and Collaborators

University of Washington

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Principal Investigator:	Karina L Walters, MSW, PhD	University of Washington
Study Director:	Rachelle McCarty, ND, MPH	University of Washington

More Information

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Additional Information:

Indigenous Wellness Research Institute at the University of Washington 

Publications:

Walters KL, LaMarr J, Levy RL, Pearson C, Maresca T, Mohammed SA, Simoni JM, Evans-Campbell T, Fredriksen-Goldsen K, Fryberg S, Jobe JB; həli?dxw Intervention Team. Project həli?dx(w)/Healthy Hearts Across Generations: development and evaluation design of a tribally based cardiovascular disease prevention intervention for American Indian families. J Prim Prev. 2012 Aug;33(4):197-207. doi: 10.1007/s10935-012-0274-z.

Mohammed SA, Walters KL, Lamarr J, Evans-Campbell T, Fryberg S. Finding middle ground: negotiating university and tribal community interests in community-based participatory research. Nurs Inq. 2012 Jun;19(2):116-27. doi: 10.1111/j.1440-1800.2011.00557.x. Epub 2011 Jul 15.

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
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