Home-delivered Intervention for Depressed, Cognitively Impaired Elders
Primary Purpose
Depression, Dementia, Geriatrics
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Adaptation Therapy (PATH)
Supportive Therapy
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Dementia, Geriatrics
Eligibility Criteria
Inclusion Criteria
- Age: >64 (65 years and older).
- 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.
- Severity of depression: Montgomery Asberg Depression Rating Scale (MADRS) >=18.
- 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).
- Evidence of at least mild cognitive impairment but not severe impairment (Dementia Rating Scale (DRS) total score between 90 and 133 inclusive).
- Caregiver (family member or professional) able and willing to participate in treatment.
- 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.
- Command of English sufficient to participate in therapy and research assessments.
Exclusion Criteria
- High suicide risk, i.e. intent or plan to attempt suicide in near future.
- Axis I psychiatric disorder or substance abuse other than unipolar major depression, non-psychotic depression.
- Axis II diagnosis of antisocial personality as determined by the SCID personality disorder section (using DSM-IV criteria).
- Moderate to Severe Dementia: We will exclude participants with DRS Total Score corresponding to moderate or more severe dementia (DRS Total <=90).
- 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.
- Current involvement in psychotherapy.
- Aphasia.
Sites / Locations
- Weill Cornell Medical College
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Problem Adaptation Therapy (PATH)
Supportive Therapy
Arm Description
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.
Supportive Therapy assists subjects in expressing their feelings and focusing on their strengths and abilities in working through current difficulties and transitions.
Outcomes
Primary Outcome Measures
Depression
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
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.
Full Information
NCT ID
NCT01350349
First Posted
May 6, 2011
Last Updated
March 19, 2018
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01350349
Brief Title
Home-delivered Intervention for Depressed, Cognitively Impaired Elders
Official Title
Home-delivered Intervention for Depressed, Cognitively Impaired Elders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Depression, cognitive impairment and disability often coexist in older adults and contribute to medical and psychiatric morbidity and mortality. We developed and propose to test the efficacy of a new psychosocial intervention, Problem Adaptation Therapy (PATH), for patients with major depression, cognitive impairment (up to the level of mild to moderate dementia) and disability. The proposed R01 study meets a critical need of this population, i.e. a treatment alternative for patients in whom antidepressants may have limited efficacy and for whom psychosocial interventions are underdeveloped and understudied.
The principal innovation of PATH is its personalized approach focusing on the patient's ecosystem (i.e. the patient, the caregiver, and the home-environment) and targeting behavioral problems related to both depression and disability. PATH is delivered at the patients' home, teaches the patient-caregiver dyad problem-solving skills, and incorporates environmental adaptations (including notes, signs, reminders, calendars, voice alarms) to improve the patient's functioning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Dementia, Geriatrics
Keywords
Depression, Dementia, Geriatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Problem Adaptation Therapy (PATH)
Arm Type
Experimental
Arm Description
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.
Arm Title
Supportive Therapy
Arm Type
Active Comparator
Arm Description
Supportive Therapy assists subjects in expressing their feelings and focusing on their strengths and abilities in working through current difficulties and transitions.
Intervention Type
Behavioral
Intervention Name(s)
Problem Adaptation Therapy (PATH)
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Supportive Therapy
Intervention Description
Supportive Therapy assists subjects in expressing their feelings and focusing on their strengths and abilities in working through current difficulties and transitions.
Primary Outcome Measure Information:
Title
Depression
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Disability
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Age: >64 (65 years and older).
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.
Severity of depression: Montgomery Asberg Depression Rating Scale (MADRS) >=18.
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).
Evidence of at least mild cognitive impairment but not severe impairment (Dementia Rating Scale (DRS) total score between 90 and 133 inclusive).
Caregiver (family member or professional) able and willing to participate in treatment.
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.
Command of English sufficient to participate in therapy and research assessments.
Exclusion Criteria
High suicide risk, i.e. intent or plan to attempt suicide in near future.
Axis I psychiatric disorder or substance abuse other than unipolar major depression, non-psychotic depression.
Axis II diagnosis of antisocial personality as determined by the SCID personality disorder section (using DSM-IV criteria).
Moderate to Severe Dementia: We will exclude participants with DRS Total Score corresponding to moderate or more severe dementia (DRS Total <=90).
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.
Current involvement in psychotherapy.
Aphasia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitris N. Kiosses, Ph.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home-delivered Intervention for Depressed, Cognitively Impaired Elders
We'll reach out to this number within 24 hrs