Depression Treatment and Risk for Cardiovascular Disease

Study Overview
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Brief Summary
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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.

Official Title
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Depression Treatment and Risk for Cardiovascular Disease

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Behavioral Activation (BA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depression treatment<br>Participants receive behavioral therapy for depression | Behavioral: Behavioral Activation (BA)<br>* Behavioral activation involves an exploration of the patient's individualized values and follows with goal setting to improve depression symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | 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) | Change in HRV from enrollment to post-treatment | 12 weeks |