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Problem Adaptation Therapy (PATH) vs. Supportive Therapy in Treating Depressed, Cognitively Impaired Older Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00368940
First Posted: August 29, 2006
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University
  Purpose
This study will evaluate the efficacy of Problem Adaptation Therapy (PATH) vs. Supportive Therapy for Cognitively Impaired (ST-CI) older adults in reducing depression and disability in treating depressed, cognitively impaired older adults.

Condition Intervention
Depression Behavioral: PATH Behavioral: ST-CI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Treatment for Depressed, Cognitively Impaired Elders

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Montgomery Asberg Depression Scale (MADRS) [ Time Frame: 12 week outcome ]
    Montgomery Asberg Depression Scale (MADRS) is a depression rating scale. Range of scores (1-35). Higher scores represent worse outcome (depression).

  • WHO Disability Assessment Schedule (WHODAS)-II [ Time Frame: 12-week outcome ]
    WHO Disability Assessment Schedule (WHODAS)-II is a disability scale. Range of scores: 12-43. Higher scores represent worse outcome (disability).


Secondary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: Outcome at 12 weeks ]
    Hamilton Depression Rating Scale is a scale measuring depression severity. Range of scores: 1-33. Higher scores reflect worse outcome (depression).

  • Sheehan Disability Scale. [ Time Frame: Outcome at 12 weeks ]
    Sheehan Disability Scale is a measure of disability. Range of scores: 0-20. Higher scores reflect worse outcome (disability).


Enrollment: 74
Study Start Date: April 2006
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PATH
Participants will receive PATH for 12 weeks
Behavioral: PATH
PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
Active Comparator: ST-CI
Participants will receive ST-CI for 12 weeks
Behavioral: ST-CI
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.
Other Name: Supportive Therapy for 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 efficacy of Problem Adaptation Therapy (PATH) a type of psychotherapy using a problem solving therapy (PST) approach, specially tailored compensatory strategies and environmental adaptations and caregiver involvement 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: PATH or ST-CI. Participants assigned to PATH will receive 12 weekly 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 ST-CI 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets Diagnostic and Statistical Manual for Mental Disorders(DSM)IV criteria for unipolar major depression
  • Severity of depression greater than or equal to 17 on MADRS
  • Disability as determined by at least 1 impairment in instrumental activities of daily living
  • Evidence of executive dysfunction or impairment in at least one of the following cognitive domains of Dementia Rating Scale (DRS): attention, construction, conceptualization, and memory ([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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368940


Locations
United States, New York
Cornell Institute of Geriatric Psychiatry
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Dimitris N. Kiosses, PhD Weill Medical College of Cornell University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00368940     History of Changes
Other Study ID Numbers: K23MH074659 ( U.S. NIH Grant/Contract )
0301005971
DATR AK-TNGP2
First Submitted: August 25, 2006
First Posted: August 29, 2006
Results First Submitted: February 27, 2017
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017
Last Verified: April 2017

Keywords provided by Weill Medical College of Cornell University:
Memory Deficits
Geriatric Depression
Cognitive Impairment
Executive Dysfunction
Disability
Problem Solving Therapy

Additional relevant MeSH terms:
Depression
Behavioral Symptoms