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Supportive Therapy Versus Problem Solving Therapy in Treating Depressed, Cognitively Impaired Older Adults
This study is currently recruiting participants.
Study NCT00368940   Information provided by National Institute of Mental Health (NIMH)
First Received: August 25, 2006   Last Updated: April 8, 2009   History of Changes

August 25, 2006
April 8, 2009
April 2006
August 2011   (final data collection date for 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 ]
  • Montgomery Asberg Depression Scale (at 4, 8, 12, 24 weeks)
  • WHODAS-II (at 4, 8, 12, 24 weeks)
Complete list of historical versions of study NCT00368940 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Hamilton Depression Rating Scale (at 4, 8, 12, 24 weeks)
  • Sheehan Disability Scale (at 4, 8, 12, 24 weeks)
  • PASS (at 4, 8, 12, 24 weeks)
 
Supportive Therapy Versus Problem Solving Therapy in Treating Depressed, Cognitively Impaired Older Adults
A Treatment for Depressed, Cognitively Impaired Elders

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

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.

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Depression
  • Behavioral: Problem Solving Therapy
  • Behavioral: Supportive Therapy
  • Experimental: Participants will receive problem solving therapy for 12 weeks
  • Active Comparator: Participants will receive supportive therapy for 12 weeks
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact: Timothy E. Clark, MTS 914-997-4390
United States
 
NCT00368940
Dimitris N. Kiosses, PhD, Weill Medical College of Cornell University
K23 MH074659, 0301005971, DATR AK-TNGP2
National Institute of Mental Health (NIMH)
 
Principal Investigator: Dimitris N. Kiosses, PhD Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
April 2009

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