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Clinical Trials/NCT06170255
NCT06170255CompletedPhase 1

Depression Treatment and Risk for Cardiovascular Disease

East Carolina University0 sites16 target enrollmentStarted: March 6, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
16
Primary Endpoint
Feasibility
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Depression treatment

Experimental

Participants receive behavioral therapy for depression

Intervention: Behavioral Activation (BA) (Behavioral)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Matthew Whited

Associate Professor of Psychology

East Carolina University

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