Depression Treatment and Risk for Cardiovascular Disease

NCT06170255 | Completed Phase 1

• 1 other identifier: 5K23HL109620
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Heart Rate Variability (HRV)

  12 weeks

Study Arms (1)

Depression treatment

EXPERIMENTAL

Participants receive behavioral therapy for depression

Behavioral: Behavioral Activation (BA)

Interventions

Behavioral Activation (BA) BEHAVIORAL

Behavioral activation involves an exploration of the patient's individualized values and follows with goal setting to improve depression symptoms.

Depression treatment

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• East Carolina University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 14, 2023
• Study Start: March 6, 2014
• Primary Completion: October 2, 2017
• Study Completion: October 2, 2017
• Last Updated: December 14, 2023

Record last verified: 2023-12