Home-delivered Intervention for Depressed, Cognitively Impaired Elders

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 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: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Depression
Dementia
Geriatrics
Behavioral: Problem Adaptation Therapy (PATH)
Behavioral: Supportive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home-delivered Intervention for Depressed, Cognitively Impaired Elders

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 176
Study Start Date: April 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Age: >64 (65 years and older).
  2. Diagnosis: Major depression, unipolar as determined by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID), using Diagnostic and Statistical Manual for Mental Disorders (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350349

Contacts
Contact: Dimitris Kiosses, PhD 914-997-4381 dkiosses@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York City, New York, United States, 10065
Principal Investigator: Dimitris N. Kiosses, Ph.D.         
Weill Cornell Medical College Recruiting
White Plains, New York, United States, 10605
Principal Investigator: Dimitris N. Kiosses, Ph.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Dimitris N. Kiosses, Ph.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01350349     History of Changes
Other Study ID Numbers: 1R01MH091045, 1R01MH091045
Study First Received: May 6, 2011
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Depression
Dementia
Geriatrics

Additional relevant MeSH terms:
Dementia
Depression
Depressive Disorder
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Mood Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2014