Home-delivered Intervention for Depressed, Cognitively Impaired Elders

Completed · Not applicable

Conditions studied: Depression, Dementia, Geriatrics

In brief

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.

Key facts

Study ID

NCT01350349

Run by

Weill Medical College of Cornell University

People needed

134

Starts

2011-04-01

Expected to finish

2017-02-01

Last updated by the study team

2018-03-21

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Weill Cornell Medical College — New York, New York, United States
• Weill Cornell Medical College — White Plains, New York, United States

Full record on ClinicalTrials.gov

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