Depression Treatment and Risk for Cardiovascular Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Males and females age 21-75
Meet diagnostic criteria for major depressive disorder
Framingham risk score indicating a greater than negligible 10-year risk (3% or greater) for cardiovascular disease.
Levels of depressive symptoms of at least moderate level (beck depression inventory II score > 19 of 63 possible points; or a Hamilton depression rating scale > 12 of 50 possible points)
Exclusion Criteria:
A verbal expression of current, significant, suicidal ideation; a score of > 15 on the beck scale for suicidal ideation
Score of >1 on any single item of the Beck Scale for Suicidal Ideation
Score of > 1 on the item assessing suicidal ideation on the beck depression inventory II.
Psychiatric diagnoses that could potentially interfere with depression treatment (current post traumatic stress disorder, bipolar I disorder, obsessive-compulsive disorder, bulimia or anorexia nervosa, schizophrenia, and panic disorder)
Current use of an antidepressant medication
Currently in psychotherapy.
Current use of a beta blocker, anxiolytic (benzodiazepine), antipsychotic agent
Diagnosis of CVD.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Depression treatment
Participants receive behavioral therapy for depression
|
Behavioral activation involves an exploration of the patient's individualized values and follows with goal setting to improve depression symptoms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility
Time Frame: 2 years. Throughout the course of the study (number recruited/screened, number enrolled, number completing the study)
|
Feasibility of the study including recruitment, enrollment, and retention rates
|
2 years. Throughout the course of the study (number recruited/screened, number enrolled, number completing the study)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Variability (HRV)
Time Frame: 12 weeks
|
Change in HRV from enrollment to post-treatment
|
12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5K23HL109620 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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