Depression Treatment and Risk for Cardiovascular Disease

Depression Clinical Trial

Official title:

Depression Treatment and Risk for Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06170255
• Other study ID #: 5K23HL109620
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 6, 2014
• Est. completion date: October 2, 2017

Study information

• Verified date: December 2023
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2, 2017
• Est. primary completion date: October 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Behavioral Activation (BA)
Behavioral activation involves an exploration of the patient's individualized values and follows with goal setting to improve depression symptoms.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
East Carolina University	National Heart, Lung, and Blood Institute (NHLBI), National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart Rate Variability (HRV)	Change in HRV from enrollment to post-treatment	12 weeks