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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT00540865

Collaborator

National Institute of Mental Health (NIMH) (NIH)

187

Enrollment

Locations

Arms

Duration (Months)

93.5

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Problem-solving therapy (PST) Behavioral: Case management (CM)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

187 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Case Management and Problem Solving Therapy for Depressed, Homebound, Low-Income Elders

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Depression [Measured at pretreatment and Weeks 3, 6, 9, 12, and 24]

Secondary Outcome Measures

Disability [Measured at pretreatment and Weeks 3, 6, 9, 12, and 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California - San Francisco	San Francisco	California	United States	94143
2	Weill Medical College of Cornell University	White Plains	New York	United States	10605

Sponsors and Collaborators

Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: George S. Alexopoulos, MD, Weill Medical College of Cornell University
Principal Investigator: Patricia A. Arean, PhD, University of California, San Francisco