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Effectiveness of Problem Solving Therapy in Treating Depressed, Cognitively Impaired Older Adults

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of Problem Solving Therapy in Treating Depressed, Cognitively Impaired Older Adults
Official Title  A Treatment for Depressed, Cognitively Impaired Elders
Brief Summary

This study will evaluate the effectiveness of problem solving therapy in treating depressed, cognitively impaired older adults.

Detailed Description

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.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Montgomery Asberg Depression Scale (MADRS) [ Time Frame: Measured at Weeks 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
WHO Disability Assessment Schedule (WHODAS)-II [ Time Frame: Measured at Weeks 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Hamilton Depression Rating Scale [ Time Frame: Measured at Weeks 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
Sheehan Disability Scale [ Time Frame: Measured at Weeks 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
Condition  Depression
Memory Deficits
Intervention  Behavioral: Problem Solving Therapy
Behavioral: Supportive Therapy
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  120
Start Date  April 2006
Completion Date August 2011
Eligibility Criteria 

Inclusion Criteria:

  • Meets DSM-IV criteria for unipolar major depression
  • Severity of depression greater than or equal to 20 on MADRS
  • Disability as determined by a score of 31 or more on the 12-item WHODAS-II
  • Evidence of executive dysfunction associated with poor response to pharmacotherapy: Mattis IP and Stroop Color-Word 2 standard deviation (SD) below the mean of normal elders (scaled score less than 5)
  • Impairment in at least one of the following cognitive domains of Dementia Rating Scale (DRS): attention, construction, conceptualization, and memory (e.g., 1 SD below the mean of normal elders [scaled score less than 7] adjusted for age and race based on Mayo's older participants normative data)
  • Family member or caregiver able and willing to participate in treatment
  • Not currently taking antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 8 weeks prior to study entry with no medical recommendation for change of these agents in the near future

Exclusion Criteria:

  • High suicide risk
  • Axis I psychiatric disorder or substance abuse other than unipolar major depression or nonpsychotic depression
  • Axis II diagnosis of antisocial personality
  • Moderate to severe dementia: DRS total score corresponding to moderate or more severe impairment (scaled score less than or equal to 5)
  • Acute or severe medical illness (e.g., delirium; metastatic cancer; decompensated cardiac; liver or kidney failure; major surgery; stroke; myocardial infarction during the 3 months prior to entry)
  • Currently taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)
  • Currently receiving psychotherapy
  • Aphasia
  • Sensory problems
  • Inability to speak English
Gender Both
Ages 65 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Timothy E. Clark, MTS     914-997-4390        
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00368940
Organization ID K23 MH74659
Secondary IDs †† 0301005971, DATR AK-TNGP2
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Dimitris N. Kiosses, PhD     Weill Medical College of Cornell University    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  August 25, 2006
Last Updated Date February 8, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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