CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 494 enrolled
Drug / intervention
Medication Management +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03688100
NCT03688100Phase 4Completed

Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure

Cedars-Sinai Medical Center·interventional·Posted Sep 28, 2018·Updated Mar 19, 2024

In Brief

A Phase 4 clinical trial evaluating Behavioral Activation Therapy and Medication Management for Depression and Heart Failure. Completed, enrolled 494 participants across 1 site.

Detailed Summary

We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with anti-depressant medications. In this study we want to compare the effectiveness of these two treatment options to learn which treatment works better.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedSep 28, 2018
Enrollment StartNov 9, 2018
Primary CompletionOct 25, 2021
Study CompletionMay 6, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.8 years ago

Interventions

Behavioral Activation Therapybehavioral

The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement.

Medication Managementdrug

Collaborative care model will be used. The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter.