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Home-delivered Intervention for Depressed, Cognitively Impaired Elders

Primary Purpose

Depression, Dementia, Geriatrics

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Problem Adaptation Therapy (PATH)

Supportive Therapy

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Dementia, Geriatrics

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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.

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.

Sites / Locations

Weill Cornell Medical College
Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Problem Adaptation Therapy (PATH)

Supportive Therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01350349

First Posted

May 6, 2011

Last Updated

March 19, 2018

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01350349

Brief Title

Home-delivered Intervention for Depressed, Cognitively Impaired Elders

Official Title

Home-delivered Intervention for Depressed, Cognitively Impaired Elders

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Dementia, Geriatrics

Keywords

Depression, Dementia, Geriatrics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

134 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Problem Adaptation Therapy (PATH)

Arm Type

Experimental

Arm Description

Arm Title

Supportive Therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Problem Adaptation Therapy (PATH)

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Supportive Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Depression

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Disability

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dimitris N. Kiosses, Ph.D.

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Weill Cornell Medical College

City

White Plains

State/Province

New York

ZIP/Postal Code

10605

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Home-delivered Intervention for Depressed, Cognitively Impaired Elders

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