Evidence map›Paper›PMID 33412562›Full record

Trial reportPloS one2021

Personalized treatments for depressive symptoms in patients with advanced heart failure: A pragmatic randomized controlled trial.

Waguih William IsHak, Samuel Korouri, Tarneem Darwish, Brigitte Vanle, Jonathan Dang, Gabriel Edwards, Jeanne T Black, Harriet Aronow, Asher Kimchi, Brennan Spiegel and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03688100 (Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03688100 phase4completednot on this map

Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure

TypeinterventionalSponsorCedars-Sinai Medical CenterRan2018 to 2022Enrolled494ConditionsDepression, Heart FailureArmsBehavioral Activation Therapy, Medication Management
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Waguih William IsHakDepartment of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.ORCID 0000-0003-1970-4756
Samuel KorouriDepartment of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.
Tarneem DarwishDepartment of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.
Brigitte VanleDepartment of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.
Jonathan DangDepartment of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.
Gabriel EdwardsDepartment of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.
Jeanne T BlackDivision of Health Services Research, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.
Harriet AronowDivision of Health Services Research, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.
Asher KimchiCedars-Sinai Smidt Heart Institute, Los Angeles, CA, United States of America.
Brennan SpiegelDavid Geffen School of Medicine at UCLA, Los Angeles, CA, United States of America.
Rebecca HedrickDepartment of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.ORCID 0000-0002-3692-8826
Robert ChernoffDepartment of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.ORCID 0000-0003-2470-0610
Marcio A DinizBiostatistics Research Center, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.
James MirochaBiostatistics Research Center, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.
Vicki ManoukianDepartment of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.
John HaroldCedars-Sinai Smidt Heart Institute, Los Angeles, CA, United States of America.ORCID 0000-0001-6475-4002
Michael K OngDavid Geffen School of Medicine at UCLA, Los Angeles, CA, United States of America.
Kenneth WellsDavid Geffen School of Medicine at UCLA, Los Angeles, CA, United States of America.ORCID 0000-0002-7454-6589
Michele HamiltonCedars-Sinai Smidt Heart Institute, Los Angeles, CA, United States of America.
Itai DanovitchDepartment of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesHeart Failure is a chronic syndrome affecting over 5.7 million in the US and 26 million adults worldwide with nearly 50% experiencing depressive symptoms. The objective of the study is to compare the effects of two evidence-based treatment options for adult patients with depression and advanced heart failure, on depressive symptom severity, physical and mental health related quality of life (HRQoL), heart-failure specific quality of life, caregiver burden, morbidity, and mortality at 3, 6 and 12-months.

methodsTrial design. Pragmatic, randomized, comparative effectiveness trial. Interventions. The treatment interventions are: (1) Behavioral Activation (BA), a patient-centered psychotherapy which emphasizes engagement in enjoyable and valued personalized activities as selected by the patient; or (2) Antidepressant Medication Management administered using the collaborative care model (MEDS). Participants. Adults aged 18 and over with advanced heart failure (defined as New York Heart Association (NYHA) Class II, III, and IV) and depression (defined as a score of 10 or above on the PHQ-9 and confirmed by the MINI International Neuropsychiatric Interview for the DSM-5) selected from all patients at Cedars-Sinai Medical Center who are admitted with heart failure and all patients presenting to the outpatient programs of the Smidt Heart Institute at Cedars-Sinai Medical Center. We plan to randomize 416 patients to BA or MEDS, with an estimated 28% loss to follow-up/inability to collect follow-up data. Thus, we plan to include 150 in each group for a total of 300 participants from which data after randomization will be collected and analyzed.

conclusionsThe current trial is the first to compare the impact of BA and MEDS on depressive symptoms, quality of life, caregiver burden, morbidity, and mortality in patients with depression and advanced heart failure. The trial will provide novel results that will be disseminated and implemented into a wide range of current practice settings. REGISTRATION: ClinicalTrials.Gov Identifier: NCT03688100.

Indexed as

Precision MedicineAgedAntidepressive AgentsDepressionDisease ProgressionEvidence-Based MedicineFemaleHeart FailureHumansMaleMiddle AgedPsychotherapyQuality of LifeAntidepressive Agents

Identifiers

PMID33412562
PMCPMC7790529

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.