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:
Weill Medical College of Cornell University
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
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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
- Age: >64 (65 years and older).
- Diagnosis: Major depression, unipolar as determined by the SCID (using 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350349
Contacts
| Contact: Timothy E. Clark, MTS | 914-997-4390 | tec2004@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: | May 2, 2012 |
| 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 Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on June 17, 2013