Problem Adaptation Therapy (PATH) vs. Supportive Therapy in Treating Depressed, Cognitively Impaired Older Adults

April 28, 2017 updated by: Weill Medical College of Cornell University

A Treatment for Depressed, Cognitively Impaired Elders

This study will evaluate the efficacy of Problem Adaptation Therapy (PATH) vs. Supportive Therapy for Cognitively Impaired (ST-CI) older adults in reducing depression and disability in treating depressed, cognitively impaired older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression, cognitive impairment, and disability often coexist in older adults and can lead to patient suffering and family disruption. Moreover, many depressed, cognitively impaired older adults have slow, poor, or unstable response to antidepressant drugs. Despite the need for treatments other than medication, most psychotherapy research focuses on either cognitively intact patients with limited disability or on dementia patients with pronounced disability. Thus, the available treatments do not fully address the needs of the large number of depressed elders with intermediate cognitive impairment and disability. Previous studies with cognitively impaired psychiatric populations have taught participants compensatory strategies to overcome their behavioral and cognitive limitations. This study will evaluate the efficacy of Problem Adaptation Therapy (PATH) a type of psychotherapy using a problem solving therapy (PST) approach, specially tailored compensatory strategies and environmental adaptations and caregiver involvement in treating depressed, cognitively impaired older adults.

All participants in this single-blind study will undergo initial evaluations, including a 2-hour interview to assess depression, memory, and physical functioning; questions about medical history; and a neuropsychological exam. Participants will then be randomly assigned to one of two treatment groups: PATH or ST-CI. Participants assigned to PATH will receive 12 weekly sessions conducted at the home of the participants. During these sessions, a therapist will identify the participant's difficulties in life related to depression and physical functioning and will provide strategies to overcome these difficulties. The goal of treatment is to improve adaptive functioning in the home environment, which in turn may reduce depression and disability. The first session will last between 1 and 2 hours, and the remaining 11 sessions will last 1 hour. Participants assigned to ST-CI will also receive 12 weekly treatment sessions with a therapist conducted at the home of the participants. During supportive therapy sessions, the therapist will help participants to express feelings and to focus on their strengths and abilities when working through difficulties and transitions. For all participants, initial assessments will be repeated at Weeks 4, 8, 12, and 24.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • White Plains, New York, United States, 10605
        • Cornell Institute of Geriatric Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets Diagnostic and Statistical Manual for Mental Disorders(DSM)IV criteria for unipolar major depression
  • Severity of depression greater than or equal to 17 on MADRS
  • Disability as determined by at least 1 impairment in instrumental activities of daily living
  • Evidence of executive dysfunction or impairment in at least one of the following cognitive domains of Dementia Rating Scale (DRS): attention, construction, conceptualization, and memory ([scaled score less than 7] adjusted for age and race based on Mayo's older participants normative data)
  • Family member or caregiver able and willing to participate in treatment
  • Not currently taking antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 8 weeks prior to study entry with no medical recommendation for change of these agents in the near future

Exclusion Criteria:

  • High suicide risk
  • Axis I psychiatric disorder or substance abuse other than unipolar major depression or nonpsychotic depression
  • Axis II diagnosis of antisocial personality
  • Moderate to severe dementia: DRS total score corresponding to moderate or more severe impairment (scaled score less than or equal to 5)
  • Acute or severe medical illness (e.g., delirium; metastatic cancer; decompensated cardiac; liver or kidney failure; major surgery; stroke; myocardial infarction during the 3 months prior to entry)
  • Currently taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)
  • Currently receiving psychotherapy
  • Aphasia
  • Sensory problems
  • Inability to speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PATH
Participants will receive PATH for 12 weeks
Behavioral: PATH
PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
Active Comparator: ST-CI
Participants will receive ST-CI for 12 weeks
Behavioral: ST-CI
Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
Other Names:
  • Supportive Therapy for Cognitively Impaired Older Adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery Asberg Depression Scale (MADRS)
Time Frame: 12 week outcome
Montgomery Asberg Depression Scale (MADRS) is a depression rating scale. Range of scores (1-35). Higher scores represent worse outcome (depression).
12 week outcome
WHO Disability Assessment Schedule (WHODAS)-II
Time Frame: 12-week outcome
WHO Disability Assessment Schedule (WHODAS)-II is a disability scale. Range of scores: 12-43. Higher scores represent worse outcome (disability).
12-week outcome

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Rating Scale
Time Frame: Outcome at 12 weeks
Hamilton Depression Rating Scale is a scale measuring depression severity. Range of scores: 1-33. Higher scores reflect worse outcome (depression).
Outcome at 12 weeks
Sheehan Disability Scale.
Time Frame: Outcome at 12 weeks
Sheehan Disability Scale is a measure of disability. Range of scores: 0-20. Higher scores reflect worse outcome (disability).
Outcome at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Dimitris N. Kiosses, PhD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

August 25, 2006

First Submitted That Met QC Criteria

August 25, 2006

First Posted (Estimate)

August 29, 2006

Study Record Updates

Last Update Posted (Actual)

July 24, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23MH074659 (U.S. NIH Grant/Contract)
  • 0301005971
  • DATR AK-TNGP2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on PATH

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe