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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00540865 |
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 |
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Depression |
Behavioral: Problem-solving therapy (PST) Behavioral: Case management (CM) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Case Management and Problem Solving Therapy for Depressed, Homebound, Low-Income Elders |
Estimated Enrollment: | 200 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Participants will receive problem-solving therapy and case management
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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.
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B: Active Comparator
Participants will receive case management
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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.
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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.
Ages Eligible for Study: | 65 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Timothy E. Clark, MTS | 914-997-4390 | tec2004@med.cornell.edu |
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 |
Principal Investigator: | George S. Alexopoulos, MD | Weill Medical College of Cornell University |
Principal Investigator: | Patricia A. Arean, PhD | University of California, San Francisco |
Responsible Party: | Weill Medical College of Cornell University ( George S. Alexopoulos, MD ) |
Study ID Numbers: | R01 MH075897, 0604008461 DATR A4-GPS |
Study First Received: | October 4, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00540865 |
Health Authority: | United States: Federal Government |
Homebound Persons Case Management Problem Solving Therapy |
Depression Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |