CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 158 enrolled
Drug / intervention
Cognitive Behavior Therapy +1 morebehavioral
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/NCT01028625
NCT01028625N/ACompleted
CompareCT.gov

Treatment of Functional Impairment in Patients With Heart Failure and Comorbid Depression

Washington University School of Medicine·interventional·Posted Dec 9, 2009·Updated May 29, 2014

In Brief

A clinical study evaluating Cognitive Behavior Therapy and Heart Failure Self-care Education for Heart Failure and Depression. Completed, enrolled 158 participants across 1 site.

Detailed Summary

The purpose of the study is to test whether Cognitive Behavior Therapy (CBT) plus heart failure self-care education is superior to "usual care" for depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Depression
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2009
Enrollment StartJan 1, 2010
Primary CompletionOct 1, 2013
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.6 years ago

Interventions

Cognitive Behavior Therapybehavioral

CBT utilizes a variety of strategies and techniques to modify cognitions and behaviors that contribute to depression such as behavioral activation; identifying and challenging distressing thoughts, beliefs, and attitudes; and systematic problem-solving. In this trial, CBT will be integrated with an intervention aimed at improving heart failure self-care, and with attention to primary caregiver stress. The CBT sessions will usually last about 50 minutes and will be scheduled weekly for up to 6 months, with additional maintenance contacts after that. The frequency of sessions will be tapered prior to 6 months if the participant meets the study criteria for depression remission and has acquired relapse-prevention skills.

Heart Failure Self-care Educationother

Participants in both arms will receive heart failure educational material from the Heart Failure Society of America. In addition, a RN will review educational material with participants during baseline visit and with 3 weekly follow up phone calls.