Clinical trial
Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure
Name
Pro00054483
Description
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.
Trial arms
Trial start
2018-11-09
Estimated PCD
2021-10-25
Trial end
2022-05-06
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Patients: Behavioral Activation Therapy (BA)
Other names:
BA
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.
Arms:
Patients: Medication Management (MEDS)
Other names:
MEDS
Size
494
Primary endpoint
Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up
6 months from baseline enrollment.
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 494, 'type': 'ACTUAL'}}
Updated at
2024-03-19
1 organization
1 product
2 indications
Organization
Cedars-Sinai Medical CenterProduct
Medication ManagementIndication
Major Depressive DisorderIndication
Congestive Heart Failure