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About
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.
Enrollment
Sex
Ages
Volunteers
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.
Primary purpose
Allocation
Interventional model
Masking
16 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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