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NCT01892124 · ClinicalTrials.gov registry record · NA
Motivational Interviewing and Cognitive Behavioral Therapy-based Intervention for Cardiovascular Disease Prevention Amongst American Indians With Diabetic and Depressive Symptoms
A NA study of Depression and Diabetes Mellitus, Type 2, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT01892124 is a NA study of Depression and Diabetes Mellitus, Type 2 that has completed, run by University of Washington. The registered enrollment target is 34 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01892124, a NA study of Depression and Diabetes Mellitus, Type 2, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study 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. S
Conditions Studied
Interventions
- BEHAVIORAL Motivational Interviewing/Cognitive Behavioral-based Therapy
Study Locations (1)
Washington
- University of Washington, Indigenous Wellness Research Institute - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01892124
The ClinicalTrials.gov registry entry for NCT01892124 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Motivational Interviewing/Cognitive Behavioral-based Therapy is the first listed.
NCT01892124 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT01892124 about?
NCT01892124 is a clinical study titled "Motivational Interviewing and Cognitive Behavioral Therapy-based Intervention for Cardiovascular Disease Prevention Amongst American Indians With Diabetic and Depressive Symptoms". 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 succes...
What is the current status of trial NCT01892124?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2013-11. Estimated completion is 2015-12.
What conditions does trial NCT01892124 study?
This clinical trial studies the following conditions: Depression, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Dysthymic Disorder.
What interventions are being tested in trial NCT01892124?
The interventions under investigation include: Motivational Interviewing/Cognitive Behavioral-based Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01892124?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01892124 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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