Home-delivered Intervention for Depressed, Cognitively Impaired Elders

This study is currently recruiting participants.
Verified May 2012 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01350349
First received: May 6, 2011
Last updated: May 2, 2012
Last verified: May 2012

May 6, 2011
May 2, 2012
April 2011
July 2016   (final data collection date for primary outcome measure)
Depression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The primary objective is to compare the efficacy of Problem Adaptation Therapy vs. Supportive Therapy in reducing depressive symptoms over a 12-week treatment period among elders with major depression, cognitive impairment, and disability.
Same as current
Complete list of historical versions of study NCT01350349 on ClinicalTrials.gov Archive Site
Disability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
A secondary objective is to compare the efficacy of Problem Adaptation Therapy vs. Supportive Therapy in reducing disability over a 12-week treatment period among elders with major depression, cognitive impairment, and disability.
Same as current
Not Provided
Not Provided
 
Home-delivered Intervention for Depressed, Cognitively Impaired Elders
Home-delivered Intervention for Depressed, Cognitively Impaired Elders

Among older adults the combination of depression, cognitive impairment (memory problems), and disability contribute to a worsening of physical and mental health and to poor treatment outcomes. Antidepressants help fewer than 40% of depressed elders with memory problems achieve remission from their depression. Interventions involving talking therapy are underdeveloped and understudied. Therefore, this research study will test the efficacy of Problem Adaptation Therapy (PATH), a new home-delivered psychosocial intervention for elders with major depression, memory problems, and disability. PATH focuses on the subject's "ecosystem" (the patient, the caregiver, and the home-environment) and targets behavioral problems related to both depression and disability.

PATH is delivered in a subject's home, where cognitively impaired, disabled elders face most of their difficulties. Local Home Delivered Meals programs will refer clients who have symptoms of depression and are interested in research. All participants will have an available caregiver (family, significant other, or professional) and will be randomized to 12 weekly sessions of PATH or Supportive Therapy, the current standard of care for talking therapy. The study will test whether home-delivered PATH is more effective than home-delivered Supportive Therapy in reducing the subjects' depression and disability and in increasing self-efficacy over the 12-week treatment period.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depression
  • Dementia
  • Geriatrics
  • Behavioral: Problem Adaptation Therapy (PATH)
    Problem Adaptation Therapy (PATH) focuses on the subject, the caregiver, and the subject's home-environment, to encourage problem-solving and adaptive functioning. The goal of PATH is to decrease depression and disability.
  • Behavioral: Supportive Therapy
    Supportive Therapy assists subjects in expressing their feelings and focusing on their strengths and abilities in working through current difficulties and transitions.
  • Experimental: Problem Adaptation Therapy (PATH)
    Problem Adaptation Therapy (PATH) focuses on the subject, the caregiver, and the subject's home-environment, to encourage problem-solving and adaptive functioning. The goal of PATH is to decrease depression and disability.
    Intervention: Behavioral: Problem Adaptation Therapy (PATH)
  • Active Comparator: Supportive Therapy
    Supportive Therapy assists subjects in expressing their feelings and focusing on their strengths and abilities in working through current difficulties and transitions.
    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.
 
Recruiting
176
July 2016
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Age: >64 (65 years and older).
  2. Diagnosis: Major depression, unipolar as determined by the SCID (using DSM-IV criteria).
  3. Severity of depression: Montgomery Asberg Depression Rating Scale (MADRS) >=18.
  4. Disability, i.e. impairment in at least 1 Instrumental Activity of Daily Living as measured by Philadelphia Multilevel Assessment Instrument - Instrumental Activities of Daily Living subscale (MAI-IADL).
  5. Evidence of at least mild cognitive impairment but not severe impairment (Dementia Rating Scale (DRS) total score between 90 and 133 inclusive).
  6. Caregiver (family member or professional) able and willing to participate in treatment.
  7. Off antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 12 weeks and no medical recommendation for change of these agents in the near future.
  8. Command of English sufficient to participate in therapy and research assessments.

Exclusion Criteria

  1. High suicide risk, i.e. intent or plan to attempt suicide in near future.
  2. Axis I psychiatric disorder or substance abuse other than unipolar major depression, non-psychotic depression.
  3. Axis II diagnosis of antisocial personality as determined by the SCID personality disorder section (using DSM-IV criteria).
  4. Moderate to Severe Dementia: We will exclude participants with DRS Total Score corresponding to moderate or more severe dementia (DRS Total <=90).
  5. Acute or severe medical illness (i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry); drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids); or chronic addictive drug use.
  6. Current involvement in psychotherapy.
  7. Aphasia.
Both
65 Years and older
No
Contact: Timothy E. Clark, MTS 914-997-4390 tec2004@med.cornell.edu
United States
 
NCT01350349
1R01MH091045, 1R01MH091045
Yes
Weill Medical College of Cornell University
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Principal Investigator: Dimitris N. Kiosses, Ph.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
May 2012

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