Cardiovascular DiseasesNCT01892124
Motivational Interviewing and Cognitive Behavioral Therapy-based Intervention for Cardiovascular Disease Prevention Amongst American Indians With Diabetic and Depressive Symptoms
A study testing Motivational Interviewing/Cognitive Behavioral-based Therapy in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Depression
- What is being tested?
- Motivational Interviewing/Cognitive Behavioral-based Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, Indigenous Wellness Research Institute
Seattle, Washington, 98105
About this study
Official title: 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.
- Being tested
- Motivational Interviewing/Cognitive Behavioral-based Therapy
- Keywords
- Motivational Interviewing, Cognitive Therapy, Community-Based Participatory Research, Indians, North American
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Depression, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing/Cognitive Behavioral-based TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing/Cognitive Behavioral-based Therapy | Experimental | Receives an immediate weekly 10 session intervention based on a culturally-adapted, motivational interviewing and Cognitive Behavioral Therapy grounded protocol. Receives: Behavioral: Motivational Interviewing/Cognitive Behavioral-based Therapy |
| Wait-List Control | Experimental | 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. Receives: Behavioral: Motivational Interviewing/Cognitive Behavioral-based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at baseline, 3 month, and 6 month timepoints
Secondary outcomes (5)
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.
Measured: Assessed at baseline, 3 month, and 6 month timepoints
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.
Measured: Assessed at baseline, 3 month, and 6 month timepoints
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.
Measured: Assessed at baseline, 3 month, and 6 month timepoints
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.
Measured: Assessed at baseline, 3 month, and 6 month timepoints
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.
Measured: Assessed at baseline, 3 month, and 6 month timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Karina Walters, University of Washington
- Investigators
- Karina L Walters, MSW, PhD, Principal investigator, University of WashingtonRachelle McCarty, ND, MPH, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892124
- Sponsor's protocol ID
- 44890-G
- Other IDs
- P60MD006909
- Status last verified
- Dec 2015
- First submitted
- 28 Jun 2013
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22965622Mohammed 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.
PubMed 22530859
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Hearts, Healthy Minds
- ClinicalTrials.gov ID
- NCT01892124
- Acronym / sponsor ID
- 44890-G
- Keywords
- Motivational Interviewing, Cognitive Therapy, Community-Based Participatory Research, Indians, North American
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing/Cognitive Behavioral-based Therapy | Experimental | Behavioral: Motivational Interviewing/Cognitive Behavioral-based TherapyReceives an immediate weekly 10 session intervention based on a culturally-adapted, motivational interviewing and Cognitive Behavioral Therapy grounded protocol. |
| Wait-List Control | Experimental | Behavioral: Motivational Interviewing/Cognitive Behavioral-based TherapyReceives 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing/Cognitive Behavioral-based Therapy | Behavioural | Motivational Interviewing/Cognitive Behavioral-based Therapy, Wait-List Control |
Primary outcome
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.
5 secondary outcomes
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
Changes in Blood Lipids
Time frame: Assessed at baseline, 3 month, and 6 month timepoints
Changes in Blood Glucose
Time frame: Assessed at baseline, 3 month, and 6 month timepoints
Changes in Hemoglobin A1c
Time frame: Assessed at baseline, 3 month, and 6 month timepoints
Changes in Blood Pressure
Time frame: Assessed at baseline, 3 month, and 6 month timepoints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- Background: PubMed 22965622Walters 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.
- Background: PubMed 22530859Mohammed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina L Walters, MSW, PhD principal investigator
University of Washington
Rachelle McCarty, ND, MPH study director
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing/Cognitive Behavioral-based Therapy in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (time frame: Assessed at baseline, 3 month, and 6 month timepoints). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892124, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.