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Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure

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ClinicalTrials.gov Identifier: NCT03688100
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Waguih William IsHak, MD, FAPA, Cedars-Sinai Medical Center

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688100


Contacts
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Contact: Vicki A Manoukian, Coordinator, MA 310-423-5067 vicki.manoukian@cshs.org

Locations
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United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Vicki A Manoukian, MA    310-423-5067    vicki.manoukian@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
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Principal Investigator: Waguih W IsHak, MD, FAPA Cedars-Sinai Medical Center

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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     History of Changes
Other Study ID Numbers: Pro00054483
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heart Failure
Depression
Behavioral Symptoms
Heart Diseases
Cardiovascular Diseases