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

Depression Clinical Trial

Official title:

Healthy Hearts, Healthy Minds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892124
• Other study ID #: 44890-G
• Secondary ID: P60MD006909
• Status: Completed
• Phase: N/A
• First received: June 28, 2013
• Last updated: December 11, 2015
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Depression
• Diabetes Mellitus, Type 2
• Dysthymic Disorder

Intervention

Behavioral:
• Motivational Interviewing/Cognitive Behavioral-based Therapy

Locations

Country	Name	City	State
United States	University of Washington, Indigenous Wellness Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Walters KL, LaMarr J, Levy RL, Pearson C, Maresca T, Mohammed SA, Simoni JM, Evans-Campbell T, Fredriksen-Goldsen K, Fryberg S, Jobe JB; h?li?dxw Intervention Team. Project h?li?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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Physical Activity	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.	Assessed at baseline, 3 month, and 6 month timepoints	No
Other	Changes in Sedentary Activity	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.	Assessed at baseline, 3 month, and 6 month timepoints	No
Other	Changes in Food Habits	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.	Assessed at baseline, 3 month, and 6 month timepoints	No
Primary	Change in Body Mass Index	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.	Assessed at baseline, 3 month, and 6 month timepoints	No
Secondary	Changes in Depressive Symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D)	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.	Assessed at baseline, 3 month, and 6 month timepoints	No
Secondary	Changes in Blood Lipids	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.	Assessed at baseline, 3 month, and 6 month timepoints	No
Secondary	Changes in Blood Glucose	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.	Assessed at baseline, 3 month, and 6 month timepoints	No
Secondary	Changes in Hemoglobin A1c	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.	Assessed at baseline, 3 month, and 6 month timepoints	No
Secondary	Changes in Blood Pressure	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.	Assessed at baseline, 3 month, and 6 month timepoints	No

External Links

•   Indigenous Wellness Research Institute at the University of Washington