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Effectiveness of Case Management Versus Case Management Plus Problem-solving Therapy to Treat Depression in Low-income Elders

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00540865
First received: October 4, 2007
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

This study will compare the effectiveness of case management combined with problem-solving therapy (CM-PST) versus case management (CM) alone for assisting elderly people with depression.


Condition Intervention
Depression
Behavioral: Problem-solving therapy (PST)
Behavioral: Case management (CM)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Case Management and Problem Solving Therapy for Depressed, Homebound, Low-Income Elders

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Depression [ Time Frame: Measured at pretreatment and Weeks 3, 6, 9, 12, and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disability [ Time Frame: Measured at pretreatment and Weeks 3, 6, 9, 12, and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2007
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Participants will receive problem-solving therapy and case management
Behavioral: Problem-solving therapy (PST)
The premise of PST is that psychotherapies implicitly help people to become better managers of their lives, in effect, to become better at solving problems. Unlike Case Management (CM) that seeks to increase its clients' availability and utilization of resources, PST focuses on the patients themselves and helps them develop skills in identifying, prioritizing, and solving problems, and thereby creates a sense of empowerment. Although CM and PST have different theoretical premises, they both focus on the resolution of concrete problems promoting depression.
Behavioral: Case management (CM)
Different types of CM exist, but all share the theme of helping individuals cope with their illnesses through linkage to social services, advocacy, rehabilitation, and ongoing support during recovery from illnesses. CM will consist of the following components: 1) socialization to treatment; 2) needs assessment; 3) psychoeducation about depression; 4) service planning; 5) linkage to social services; 6) help with access to health care; 7) advocacy; and 8) exploration of barriers that perpetuate unmet needs.
Active Comparator: B
Participants will receive case management
Behavioral: Case management (CM)
Different types of CM exist, but all share the theme of helping individuals cope with their illnesses through linkage to social services, advocacy, rehabilitation, and ongoing support during recovery from illnesses. CM will consist of the following components: 1) socialization to treatment; 2) needs assessment; 3) psychoeducation about depression; 4) service planning; 5) linkage to social services; 6) help with access to health care; 7) advocacy; and 8) exploration of barriers that perpetuate unmet needs.

Detailed Description:

Depression is a common mental disorder that affects many low-income elders. Many elders suffer from multiple chronic illnesses and often must deal with social and financial hardships as they continue to age. Rates of diagnosis and treatment for depression within the elderly population are low. This may be because elders are embarrassed to discuss their symptoms with their doctor and assume sadness and anxiety are a normal part of the aging process. However, depression is not a normal consequence of aging. Furthermore, it can severely impact people's lives, sleep patterns, concentration, and energy levels. This study will compare the effectiveness of case management combined with problem-solving therapy (CM-PST) versus case management (CM) alone for assisting elderly people diagnosed with depression.

CM involves identifying a person's particular needs and working with a case worker to plan and implement specific resources and services that will meet those needs. PST emphasizes the social context of an individual's situation through problem-solving and behavior change techniques. Recent studies have suggested that combining CM with PST may have a mutually beneficial effect on depressed, low-income elders. CM can help elders with their social and financial needs, and PST can improve their ability to cope with stressful events and utilize their new resources.

Participants in this open-label study will be randomly assigned to receive 12 sessions of either CM or CM-PST. Both treatments will be delivered at the participant's home by a trained case worker. Participants assigned to receive CM will focus on increasing their resources and reducing adversity. The case worker will help participants determine the causes of their unmet needs, create an action plan to meet those needs, encourage the use of services, and possibly advise their family members and health care providers to help facilitate the use of those services. Participants assigned to CM-PST will undergo a needs assessment during the first session to develop a problem-solving plan that will be implemented over the next 11 sessions. Each session will include instruction on how to use the PST approach to solve problems identified by both the therapist and participant. All participants will undergo a neuropsychological exam and complete psychological and physical functioning questionnaires prior to treatment and at Weeks 3, 6, 12, and 24.

  Eligibility

Ages Eligible for Study:   60 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receives home-delivered meal service
  • Has at least one instrumental activity of daily living (IADL) impairment
  • Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)IV criteria for unipolar major depression
  • Considered low income (30% of the local median income)
  • Has a need for social services
  • Experiences problem-solving difficulties
  • Speaks English

Exclusion Criteria:

  • Diagnosis of psychotic depression or experiences delusions
  • Suicidal
  • Diagnosed with any Axis I psychiatric disorder other than unipolar major depression
  • History of substance abuse
  • Axis II diagnosis of antisocial personality
  • History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder, such as bipolar disorder, hypomania, or dysthymia
  • Diagnosed with dementia
  • Acute or severe medical illness, such as delirium, metastatic cancer, major surgery, stroke, heart attack, or decompensated heart, liver, or kidney failure within 3 months of study entry
  • Use of drugs known to cause depression, such as steroids, reserpine, alpha-methyl-dopa, tamoxifen, or vincristine
  • Use of antidepressants
  • Currently receiving psychotherapy
  • Inability to perform any of the activities of daily living (ADLs) even with assistance
  • Aphasia interfering with communication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540865

Contacts
Contact: Patrick Raue, PhD 914-997-8684 praue@med.cornell.edu

Locations
United States, California
University of California - San Francisco Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Patricia A. Arean, PhD         
United States, New York
Weill Medical College of Cornell University Recruiting
White Plains, New York, United States, 10605
Principal Investigator: George S. Alexopoulos, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: George S. Alexopoulos, MD Weill Medical College of Cornell University
Principal Investigator: Patricia A. Arean, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00540865     History of Changes
Obsolete Identifiers: NCT00504868
Other Study ID Numbers: R01 MH075897, R01MH075897, 0604008461 DATR A4-GPS
Study First Received: October 4, 2007
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Homebound Persons
Case Management
Problem Solving Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014