NCT06170255
Completed
Phase 1
Depression Treatment and Risk for Cardiovascular Disease
ConditionsDepression
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- East Carolina University
- Enrollment
- 16
- Primary Endpoint
- Feasibility
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study was designed to determine the feasibility of a Randomized Controlled Trial (RCT) that involved treating depression among participants with an elevated risk for cardiovascular disease. It is expected that treating depression through non-pharmacological means will impact heart rate variability, a proximal measure of CVD risk.
Investigators
Matthew Whited
Associate Professor of Psychology
East Carolina University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Heart Rate Variability (HRV)(12 weeks)
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