Home-Delivered Intervention for Depressed, Cognitively Impaired Elders
Home-Delivered Intervention for Depressed, Cognitively Impaired Elders
Overall Status:
Recruiting
Brief Description:
The combination of depression, memory problems, and disability in older adults contributes to a worsening of physical and mental health and to poor treatment outcomes. This research study will test the efficacy of Problem Adaptation Therapy (PATH), a home-delivered psychosocial intervention that focuses on the individual's "ecosystem" (individual, caregiver, and home environment) and targets behavioral problems related to both depression and disability. PATH will be delivered for 12 weeks in the home.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
65 Years | N/A | Both | No |
Inclusion Criteria:
- Major depression (unipolar), as determined by the SCID (using DSM-IV criteria); severity: Montgomery Asberg Depression Rating Scale (MADRS) of at least 18
- Impairment in at least one Instrumental Activity of Daily Living
- Mild cognitive impairment but not severe dementia (Dementia Rating Scale total score of 90-133 inclusive)
- Caregiver (family member or professional) available to participate in treatment
- English fluency sufficient to participate in therapy and research assessments
Exclusion Criteria:
- High suicide risk
- Psychiatric disorder or substance abuse other than unipolar major depression or nonpsychotic depression
- Diagnosis of antisocial personality as determined by the SCID personality disorder section (using DSM-IV criteria)
- Moderate to severe dementia
- Acute or severe medical illness (i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the 3 months prior to entry)
- Prohibited treatments: Drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids); chronic addictive drug use; current involvement in psychotherapy; antidepressants, cholinesterase inhibitors, or memantine (stable dosage for 12 weeks allowable)
- Aphasia
Detailed Description:
The combination of depression, memory problems, and disability in older adults contributes to a worsening of physical and mental health and to poor treatment outcomes. Antidepressants help fewer than 40 percent of depressed elders with memory problems achieve remission from depression. Interventions involving talking therapy are underdeveloped and understudied. This study will test the efficacy of a new approach called Problem Adaptation Therapy (PATH), a home-delivered psychosocial intervention. PATH focuses on the individual's "ecosystem" (individual, caregiver, and home environment) and targets behavioral problems related to both depression and disability.
PATH will be delivered in an elder's home, where most difficulties are faced. Local programs that deliver meals 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 participants' depression and disability and in increasing self-efficacy.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 40.7645239, -73.9624327 | Weill Cornell Medical College | New York City | New York | 10065 | Recruiting | |
Geolocation is 41.0112762, -73.7419017 | Weill Cornell Medical College | White Plains | New York | 10605 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Weill Medical College, Cornell University |
Collaborator Sponsor:
| Agency |
|---|
National Institute of Mental Health (NIMH) |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Dimitris N. Kiosses, PhD | Principal Investigator | Weill Medical College, Cornell University |
Study Contact:
| Name | Phone | |
|---|---|---|
Timothy E. Clark, MTS | 914-997-4390 |
Locations
ClinicalTrials.gov ID
NCT01350349 (follow link to view full record on ct.gov in new window)
Official Title:
Home-delivered Intervention for Depressed, Cognitively Impaired Elders
Study Start Date:
April 2011
Study End Date:
July 2016
Disease Stage:
Early
Enrollment:
176
