Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure

• ClinicalTrials.gov Identifier: NCT03688100
• Recruitment Status: Recruiting
• First Posted: September 28, 2018
• Last Update Posted: June 30, 2020
• Sponsor: Cedars-Sinai Medical Center
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Waguih William IsHak, MD, FAPA, Cedars-Sinai Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression; Heart Failure	Behavioral: Behavioral Activation Therapy; Drug: Medication Management	Phase 4

Detailed Description:

Aim 1: To compare the effectiveness of BA vs. MEDS, for depressed AHF patients. Hypothesis 1: Compared to depressed AHF patients who receive MEDS, patients receiving BA will have significantly greater improvements in the primary outcome of depressive symptom severity as measured with the PHQ-9 at 6-month follow-up. Significantly greater improvements will also be detected in the secondary outcomes of general physical and mental HRQoL (SF-12v2), heart failure-specific HRQoL (KCCQ), and caregiver burden (CBQ-HF) at 3, 6, and 12 months.

Aim 2: To compare the impact of BA vs. MEDS on disadvantageous outcomes of Morbidity (as evidenced by ED visits, hospital readmissions, total days in the hospital), and Mortality among depressed AHF patients.

Hypothesis 2: Compared to depressed AHF patients who receive MEDS, those receiving BA will have significantly less Morbidity (as evidenced by less frequent ED visits, lower readmission rates, fewer total days in the hospital), and reduced Mortality at the data collection points of 3, 6, and 12 months.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 416 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure
• Actual Study Start Date: November 9, 2018
• Estimated Primary Completion Date: June 1, 2021
• Estimated Study Completion Date: September 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Medication Management group; 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; 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.
Active Comparator: Behavioral Activation Therapy; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in depression, as measured by the Patient Health Questionnaire (PHQ-9) depression scale results at 6 months follow up [ Time Frame: 6 months from baseline enrollment. ]
   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.

Secondary Outcome Measures :

1. Change from baseline in the 12-item questionnaire used to assess generic health outcomes (SF-12v2) scale results [ Time Frame: 3 month, 6 month, and 12 months from baseline enrollment ]
   The SF-12v2 is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective.The SF-12v2 assess general physical and mental health-related quality of life (HRQoL), including the impact of any and all illnesses on a broad range of functional domains.
2. Change from baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ )scale results. [ Time Frame: 3 month, 6 month, and 12 months from baseline enrollment ]
   The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and HRQoL.Scores are transformed to a range of 0-100, in which higher scores reflect better health status. We will measure the Heart failure-specific quality of life as measured by the KCCQ.
3. Change from baseline on the Caregiver burden questionnaire-Heart Failure (CBQ-HF) scale results. [ Time Frame: 3 month, 6 month, and 12 months from baseline enrollment ]
   The Caregiver Burden Questionnaire - Heart Failure Version 3.0 (CBQ-HF) is a quantitative survey of 26 questions covering the past four weeks of the caregiver's experience is evaluated as caregiver burden. uses a 5-point Likert severity scale assessing 4 domains of physical, emotional/psychological, social and lifestyle burdens.
4. Number of Emergency Department visits [ Time Frame: 3 month, 6 month, and 12 months from baseline enrollment ]
   We will be recording number of emergency departments.
5. Number of Readmissions (hospitalization) [ Time Frame: 3 month, 6 month, and 12 months from baseline enrollment ]
   We will be recording number of readmissions to the hospital.
6. If hospitalized, total number of days in the Hospital [ Time Frame: 3 month, 6 month, and 12 months from baseline enrollment ]
   We will be recording the total number of days in the hospital if they were hospitalized.
7. Mortality will also be measured [ Time Frame: 3 month, 6 month, and 12 months from baseline enrollment ]
   We will be recording mortality data on the patients.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Samuel Korouri, Coordinator, BA; 310-423-1340; samuel.korouri@cshs.org

Locations

United States, California

Cedars Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Contact: Samuel Korouri, BA 310-423-1340 samuel.korouri@cshs.org

Principal Investigator: Waguih W Ishak, MD, FAPA

Sub-Investigator: Michelle Hamilton, MD

Sub-Investigator: Asher Kimchi, MD, FACC

Sub-Investigator: Itai Danovitch, MD

Sub-Investigator: Brennan Spiegel, MD

Sub-Investigator: Harriet Aronow, PHD

Sub-Investigator: Jeanne Black, PHD, MBA

Sub-Investigator: Rebecca Hedrick, MD

Sub-Investigator: Robert Chernoff, PHD

Sub-Investigator: Marcio Diniz, PHD

Sub-Investigator: Gabriel Edwards, MD, MPH

Sponsors and Collaborators

Cedars-Sinai Medical Center

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Waguih W IsHak, MD, FAPA; Cedars-Sinai Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Waguih William IsHak, MD, FAPA, Vice Chair, Education and Research in the Department of Psychiatry and Behavioral Neurosciences, Professor Psychiatry & Behavioral Neurosciences, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT03688100
• Other Study ID Numbers: Pro00054483
• First Posted: September 28, 2018
• Last Update Posted: June 30, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Heart Failure; Depression; Behavioral Symptoms; Heart Diseases; Cardiovascular Diseases