Home-delivered Intervention for Depressed, Cognitively Impaired Elders

NCT01350349 | Completed DMC

• 1 other identifier: 1R01MH091045
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Dementia; Geriatrics

Keywords

Depression; Dementia; Geriatrics

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Disability

  12 weeks

Study Arms (2)

Problem Adaptation Therapy (PATH)

EXPERIMENTAL

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)

Supportive Therapy

ACTIVE COMPARATOR

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

Interventions

Problem Adaptation Therapy (PATH) BEHAVIORAL

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.

Problem Adaptation Therapy (PATH)

Supportive Therapy BEHAVIORAL

Supportive Therapy assists subjects in expressing their feelings and focusing on their strengths and abilities in working through current difficulties and transitions.

Supportive Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Depression; Dementia

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dimitris N. Kiosses, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 9, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 21, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)