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CompletedNCT01350349Updated Mar 21, 2018

Home-delivered Intervention for Depressed, Cognitively Impaired Elders

An interventional study of Problem Adaptation Therapy (PATH) and Supportive Therapy in Depression, Dementia and Geriatrics, sponsored by Weill Medical College of Cornell University. Completed at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-03-21.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression
  • Dementia
  • Geriatrics

Keywords

  • Depression
  • Dementia
  • Geriatrics
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 134 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age: >64 (65 years and older).
  2. 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.
  3. Severity of depression: Montgomery Asberg Depression Rating Scale (MADRS) >=18.
  4. 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).
  5. Evidence of at least mild cognitive impairment but not severe impairment (Dementia Rating Scale (DRS) total score between 90 and 133 inclusive).
  6. Caregiver (family member or professional) able and willing to participate in treatment.
  7. 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.
  8. Command of English sufficient to participate in therapy and research assessments.

Exclusion criteria

Exclusion Criteria

  1. High suicide risk, i.e. intent or plan to attempt suicide in near future.
  2. Axis I psychiatric disorder or substance abuse other than unipolar major depression, non-psychotic depression.
  3. Axis II diagnosis of antisocial personality as determined by the SCID personality disorder section (using DSM-IV criteria).
  4. Moderate to Severe Dementia: We will exclude participants with DRS Total Score corresponding to moderate or more severe dementia (DRS Total \<=90).
  5. 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.
  6. Current involvement in psychotherapy.
  7. Aphasia.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
134 participants (actual)

Study arms

  • 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)

  • 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

Interventions

  • BehavioralProblem 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.

  • BehavioralSupportive Therapy

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

06

What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

07

Study locations

2 sites
  • Weill Cornell Medical College
    New York, New York 10065, United States
  • Weill Cornell Medical College
    White Plains, New York 10605, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01350349
Lead sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
May 9, 2011
Start date
Apr 2011
Primary completion
Feb 2017
Completion
Feb 2017
Last update
Mar 21, 2018

Study contacts

Dimitris N. Kiosses, Ph.D.
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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