Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02069912
Other study ID # USCIRB-HS-06-00420
Secondary ID CA Health Care F
Status Completed
Phase N/A
First received
Last updated
Start date November 2006
Est. completion date February 2009

Study information

Verified date February 2014
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

1. Implement an evidence-based structured care approach that includes screening; acute treatment and relapse prevention follow-up tailored for public sector clinics and low-income and minority patients. 2. Adapt an evidence-based collaborative care model for primary care, implement the adapted model, evaluate and further refine the model based on the pilot experience, and produce and disseminate a detailed manual for use in public sector clinics. 3. Evaluate Multifaceted Depression and Cardiovascular Program (MDCP) in an open trial to determine: its acceptance by patients, medical providers, and organizational decision-makers; patient depression treatment adherence; its direct cost; and the size and variability of change from baseline in the primary outcome measures: depressive symptoms, functional status, quality of life, health service use, and cardiac status at 6 and 12 month follow-up.


Description:

The pilot open trial was conducted to evaluate the effectiveness of a health services quality improvement intervention, Multifaceted Depression and Cardiovascular Program (MDCP), on reduction of major depressive disorder, adherence to recommended cardiac exercise and diet self-care regimens and appointment keeping, blood pressure and low density lipid levels, functional status, quality of life and use of health services among low-income, predominantly Hispanic adults with congestive heart failure (CHF) or other cardiac disease such as coronary artery disease (CAD) in public sector community-based primary care clinics. The study was based on key observations from recent studies: 1) Patients with cardiac conditions are more likely to experience clinically significant depressive symptoms than the general population, with depression being associated with poor cardiac outcomes; 2) depression rates are high among Hispanics with chronic illness; 3) Minority patients are less likely to receive care for depression, but benefit with culturally appropriate care enhancements; and 4) depression co-morbid with cardiac conditions is likely to be persistent. Low-income patient needs, depression illness characteristics, and public care system resources call for a multifaceted, collaborative chronic disease management model of depression care. MDCP is aimed at positively affecting depression and cardiac outcomes by reducing known patient, provider, and system barriers to care. Participation in this study will last 12 months. All participants will first undergo baseline assessments that will include a 40-minute interview about personal health and feelings. All study participants will receive collaborative depression care management. They will first be provided with information about depression treatment. Participants will then have the option of choosing between two depression treatments: counseling or antidepressant medications. Participants who choose to receive treatment with counseling will receive eight weekly 45-minute counseling sessions, conducted either on the phone or at the clinic. During these sessions, participants will undergo structured problem solving therapy (PST) and will learn strategies to manage their depressive symptoms. Participants who choose to receive treatment with antidepressant medication will be prescribed medication by a study doctor and will be monitored for any side effects throughout treatment. Medication treatment may last up to 12 months but will depend upon participants' severity of depression. After completing medication treatment, participants will be offered PST counseling. All study participants will also receive supportive patient navigation services and maintenance/relapse telephone monitoring. All participants will undergo follow-up phone interviews about their status at months 6 and 12.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Meets criteria for clinically significant depression based on a score of = 2 for one of the two cardinal depression symptoms (depressed mood or loss of interest) and a Patient Health Questionnaire-9 total score of = 10 - Patient with heart disease - Has attended Los Angeles County Department of Health Services Comprehensive Health Clinics or the Cardiology Clinic at Los Angeles County+University of Southern California Medical Center Exclusion Criteria: - Current suicidal ideation - Score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT) - Recent use of lithium or antipsychotic medication

Study Design


Intervention

Behavioral:
Collaborative depression care management
Collaborative depression care management will include acute depression treatment with antidepressant medication and/or counseling sessions based on structured problem solving therapy. Participants will also receive supportive patient navigation services and maintenance/relapse telephone monitoring. Counseling treatment will include 8 weekly 45-minute counseling sessions that are culturally and health literacy adapted for the study population. The length of medication treatment will depend upon participants' severity of depression and may last up to 12 months.

Locations

Country Name City State
United States University of Southern California School of Social Work Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California Los Angeles County Department of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive symptoms reduction Achieve minimum a 50% reduction in depressive symptoms from baseline at 6- and 12-month follow-up Measured at months 6 and 12
Secondary Improvement in quality of life Change score in quality-of-life 12-item Short-Form Health Survey, Minnesota Living with Heart Failure, Sheehan Disability Scale outcomes Measured at months 6 and 12
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A