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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: | NCT00368940 |
This study will evaluate the effectiveness of problem solving therapy in treating depressed, cognitively impaired older adults.
Condition | Intervention |
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Depression |
Behavioral: Problem Solving Therapy Behavioral: Supportive Therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Treatment for Depressed, Cognitively Impaired Elders |
Estimated Enrollment: | 120 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive problem solving therapy for 12 weeks
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Behavioral: Problem Solving Therapy
Problem solving therapy identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment.
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2: Active Comparator
Participants will receive supportive therapy for 12 weeks
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Behavioral: Supportive Therapy
Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
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Depression, cognitive impairment, and disability often coexist in older adults and can lead to patient suffering and family disruption. Moreover, many depressed, cognitively impaired older adults have slow, poor, or unstable response to antidepressant drugs. Despite the need for treatments other than medication, most psychotherapy research focuses on either cognitively intact patients with limited disability or on dementia patients with pronounced disability. Thus, the available treatments do not fully address the needs of the large number of depressed elders with intermediate cognitive impairment and disability. Previous studies with cognitively impaired psychiatric populations have taught participants compensatory strategies to overcome their behavioral and cognitive limitations. This study will evaluate the effectiveness of a type of psychotherapy called problem solving therapy (PST) as well as specially tailored compensatory strategies, in treating depressed, cognitively impaired older adults.
All participants in this single-blind study will undergo initial evaluations, including a 2-hour interview to assess depression, memory, and physical functioning; questions about medical history; and a neuropsychological exam. Participants will then be randomly assigned to one of two treatment groups: PST or supportive therapy.
Participants assigned to PST will receive 12 weekly PST sessions conducted at the home of the participants.
During these sessions, a therapist will identify the participant's difficulties in life related to depression and physical functioning and will provide strategies to overcome these difficulties. The goal of treatment is to improve adaptive functioning in the home environment, which in turn may reduce depression and disability. The first session will last between 1 and 2 hours, and the remaining 11 sessions will last 1 hour. Participants assigned to supportive therapy will also receive 12 weekly treatment sessions with a therapist conducted at the home of the participants. During supportive therapy sessions, the therapist will help participants to express feelings and to focus on their strengths and abilities when working through difficulties and transitions. For all participants, initial assessments will be repeated at Weeks 4, 8, 12, and 24.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Timothy E. Clark, MTS | 914-997-4390 |
United States, New York | |
Cornell Institute of Geriatric Psychiatry | Recruiting |
White Plains, New York, United States, 10605 |
Principal Investigator: | Dimitris N. Kiosses, PhD | Weill Medical College of Cornell University |
Responsible Party: | Weill Medical College of Cornell University ( Dimitris N. Kiosses, PhD ) |
Study ID Numbers: | K23 MH074659, 0301005971, DATR AK-TNGP2 |
Study First Received: | August 25, 2006 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00368940 History of Changes |
Health Authority: | United States: Federal Government |
Memory Deficits Geriatric Depression Cognitive Impairment |
Executive Dysfunction Disability Problem Solving Therapy |
Depression Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |
Depression Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |