Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure

NCT03688100 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00054483
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up

  PHQ-9 is used to measure depressive symptoms severity. The PHQ-9 is a self-report instrument that corresponds with the validated Primary Care Evaluation of Mental Disorders PRIME-MD clinician-administered instrument. The PHQ-9 measures all nine dimensions of depression assessed in the DSM criteria for MDD on a 0-3 scale. Minimum score = 0 (no depression). Maximum scores = 21 (worst depression)

  6 months from baseline enrollment.

Secondary Outcomes (7)

• Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results

  3 month, 6 month, and 12 months from baseline enrollment

• Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results.

  3 month, 6 month, and 12 months from baseline enrollment

• Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results.

  3 month, 6 month, and 12 months from baseline enrollment

• Mean Number of Emergency Department Visits

  3 month, 6 month, and 12 months from baseline enrollment

• Mean Number of Readmissions (Hospitalization)

  3 month, 6 month, and 12 months from baseline enrollment

Study Arms (4)

Patients: Medication Management (MEDS)

ACTIVE COMPARATOR

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.

Drug: Medication Management

Patients: Behavioral Activation Therapy (BA)

ACTIVE COMPARATOR

BA is an evidence-based psychotherapy with more than 25 randomized trials showing effectiveness in depression. 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.

Behavioral: Behavioral Activation Therapy

Caregivers: Medication Management (MEDS)

NO INTERVENTION

Caregivers of patients receiving the the above described Medication Management (MEDS) intervention were monitored for caregiver burden at 3, 6, and 12 months.

Caregivers: Behavioral Activation Psychotherapy (BA)

NO INTERVENTION

Caregivers of patients receiving the the above described Behavioral Activation Psychotherapy (BA) intervention were monitored for caregiver burden at 3, 6, and 12 months.

Interventions

Behavioral Activation Therapy BEHAVIORAL

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.

Also known as: BA

Patients: Behavioral Activation Therapy (BA)

Medication Management DRUG

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.

Also known as: MEDS

Patients: Medication Management (MEDS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HF New York Heart Association classes: II-IV.
• Life expectancy of more than 6 months.
• PHQ-9 score ≥10.
• Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), and Depressive Disorder Unspecified, as confirmed by the MINI 7.02.

You may not qualify if:

• Imminent danger to self or others.
• Cognitive impairments with a MOCA score of \< 23.
• Bipolar, Psychotic, and Substance-induced Disorders.
• Patients in active treatment of depression who are already on antidepressants, psychotherapy, or both.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (2)

• IsHak WW, Hamilton MA, Korouri S, Diniz MA, Mirocha J, Hedrick R, Chernoff R, Black JT, Aronow H, Vanle B, Dang J, Edwards G, Darwish T, Messineo G, Collier S, Pasini M, Tessema KK, Harold JG, Ong MK, Spiegel B, Wells K, Danovitch I. Comparative Effectiveness of Psychotherapy vs Antidepressants for Depression in Heart Failure: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352094. doi: 10.1001/jamanetworkopen.2023.52094.

  PMID: 38231511 DERIVED

• IsHak WW, Korouri S, Darwish T, Vanle B, Dang J, Edwards G, Black JT, Aronow H, Kimchi A, Spiegel B, Hedrick R, Chernoff R, Diniz MA, Mirocha J, Manoukian V, Harold J, Ong MK, Wells K, Hamilton M, Danovitch I. Personalized treatments for depressive symptoms in patients with advanced heart failure: A pragmatic randomized controlled trial. PLoS One. 2021 Jan 7;16(1):e0244453. doi: 10.1371/journal.pone.0244453. eCollection 2021.

  PMID: 33412562 DERIVED

MeSH Terms

Conditions

Depression; Heart Failure

Interventions

Medication Therapy Management

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Limitations and Caveats

For our secondary outcomes of Emergency Department Visits, Hospital Readmissions, and Total Days in the Hospital, we were only able to collect such data for ED visits and hospital admissions that occurred at Cedars-Sinai Medical Center and outside institutions that share data with the Cedars-Sinai Health System. As such, this data may not be complete since patients could potentially have visited different hospitals that we do not know about.

Results Point of Contact

• Title: Dr. Waguih IsHak
• Organization: Cedars-Sinai Medical Center

Waguih.IsHak@cshs.org

310-423-3515

Study Officials

• Waguih W IsHak, MD, FAPA

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Education and Research in the Department of Psychiatry and Behavioral Neurosciences, Professor Psychiatry & Behavioral Neurosciences

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: November 9, 2018
• Primary Completion: October 25, 2021
• Study Completion: May 6, 2022
• Last Updated: March 19, 2024
• Results First Posted: March 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)