Supportive Therapy Versus Problem Solving Therapy in Treating Depressed, Cognitively Impaired Older Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00368940
First received: August 25, 2006
Last updated: February 16, 2012
Last verified: February 2012

August 25, 2006
February 16, 2012
April 2006
August 2012   (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)
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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.
  • 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.
  • Experimental: 1
    Participants will receive problem solving therapy for 12 weeks
    Intervention: Behavioral: Problem Solving Therapy
  • Active Comparator: 2
    Participants will receive supportive therapy for 12 weeks
    Intervention: Behavioral: Supportive Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
August 2012
August 2012   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT00368940
K23 MH074659, K23MH074659, 0301005971, DATR AK-TNGP2
No
Weill Medical College of Cornell University
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Principal Investigator: Dimitris N. Kiosses, PhD Weill Medical College of Cornell University
Weill Medical College of Cornell University
February 2012

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