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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.
Study NCT00540865   Information provided by National Institute of Mental Health (NIMH)
First Received: October 4, 2007   Last Updated: September 18, 2009   History of Changes

October 4, 2007
September 18, 2009
May 2007
April 2012   (final data collection date for primary outcome measure)
Depression [ Time Frame: Measured at pretreatment and Weeks 3, 6, 9, 12, and 24 ] [ Designated as safety issue: No ]
Depression [ Time Frame: Measured at pre-treatment and Weeks 3, 6, 12, and 24 ]
Complete list of historical versions of study NCT00540865 on ClinicalTrials.gov Archive Site
Disability [ Time Frame: Measured at pretreatment and Weeks 3, 6, 9, 12, and 24 ] [ Designated as safety issue: No ]
Disability [ Time Frame: Measured at pretreatment and Weeks 3, 6, 12, and 24 ]
 
Effectiveness of Case Management Versus Case Management Plus Problem-solving Therapy to Treat Depression in Low-income Elders
Case Management and Problem Solving Therapy for Depressed, Homebound, Low-Income Elders

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.

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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Depression
  • Behavioral: Problem-solving therapy (PST)
  • Behavioral: Case management (CM)
  • Experimental: Participants will receive problem-solving therapy and case management
  • Active Comparator: Participants will receive case management
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Receives home-delivered meal service
  • Has at least one instrumental activity of daily living (IADL) impairment
  • Meets 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
Both
65 Years to 95 Years
No
Contact: Timothy E. Clark, MTS 914-997-4390 tec2004@med.cornell.edu
United States
 
NCT00540865
George S. Alexopoulos, MD, Weill Medical College of Cornell University
R01 MH075897, 0604008461 DATR A4-GPS
National Institute of Mental Health (NIMH)
 
Principal Investigator: George S. Alexopoulos, MD Weill Medical College of Cornell University
Principal Investigator: Patricia A. Arean, PhD University of California, San Francisco
National Institute of Mental Health (NIMH)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP