Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karina Walters, University of Washington
ClinicalTrials.gov Identifier:
NCT01892124
First received: June 28, 2013
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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 Intervention
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Depression
Dysthymic Disorder
Behavioral: Motivational Interviewing/Cognitive Behavioral-based Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Healthy Hearts, Healthy Minds

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in Body Mass Index [ Time Frame: Assessed at baseline, 3 month, and 6 month timepoints ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Changes in Physical Activity [ Time Frame: Assessed at baseline, 3 month, and 6 month timepoints ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: November 2013
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892124

Contacts
Contact: M. Tiedeman 360-716-4896 healthyhearts@iwri.org

Locations
United States, Washington
University of Washington, Indigenous Wellness Research Institute Recruiting
Seattle, Washington, United States, 98105
Contact: M. Tiedeman    360-716-4896    healthyhearts@iwri.org   
Principal Investigator: Karina Walters, MSW, PhD         
Principal Investigator: June LaMarr, PhD         
Sub-Investigator: Rona Levy, PhD         
Sub-Investigator: Jane Simoni, PhD         
Sub-Investigator: Karen Fredricksen-Goldsen, PhD         
Sub-Investigator: Terry Maresca, MD         
Sub-Investigator: Selina Mohammed, PhD         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Karina L Walters, MSW, PhD University of Washington
Principal Investigator: June LaMarr, PhD Community Principal Investigator
Study Director: Rachelle McCarty, ND, MPH University of Washington
  More Information

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
Study First Received: June 28, 2013
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Motivational Interviewing
Cognitive Therapy
Community-Based Participatory Research
Indians, North American

Additional relevant MeSH terms:
Cardiovascular Diseases
Depression
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dysthymic Disorder
Behavioral Symptoms
Depressive Disorder
Endocrine System Diseases
Glucose Metabolism Disorders
Mental Disorders
Metabolic Diseases
Mood Disorders

ClinicalTrials.gov processed this record on November 25, 2014