Therapy for Depressed Elders With Thought Problems

January 25, 2018 updated by: Pat Arean, University of Washington

PST in Geriatric Depression With Executive Dysfunction

This study will compare the effectiveness of Problem Solving Therapy and Brief Supportive Therapy in treating elderly patients with major depression and thought problems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who suffer from a combination of major depression and executive dysfunction symptoms often respond poorly to treatment with antidepressants. It is important, therefore, to find effective alternative therapies to treat these symptoms.

Patients are randomly assigned to receive 12 sessions (1 session/week for 12 weeks) of either PST or BST. Following treatment, patients are followed for 6 months to determine functional and clinical outcomes. Depression scales, disability scales, and scales that measure problem solving skills are used to assess patients.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 3

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
    • California
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
    • New York
      • White Plains, New York, United States, 10605
        • Weill Medical College of Cornell University

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Nonpsychotic, unipolar major depression
  • Cognitive impairment
  • English speaking

Exclusion Criteria:

  • High suicide risk
  • Dementia
  • Acute or severe medical illness
  • Current psychotherapy

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: 1 Problem Solving Therapy
12 weekly sessions of problem solving therapy (PST)
Behavioral: Problem Solving Therapy
A 12 week cognitive behavioral intervention for depression that teaches patients a structured approach to solving social problems.
Experimental: 2 Brief Supportive Therapy
12 weekly sessions of brief supportive therapy (BST)
Behavioral: Brief Supportive Therapy
A 12 week intervention for depression that focuses on supporting patients attempts to cope with depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Rating Scale for Depression
Time Frame: Measured at screening, weeks 1 through 12, and week 36
Measured at screening, weeks 1 through 12, and week 36

Collaborators and Investigators

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

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Patricia A. Arean, PhD, University of California at San Francisco

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

September 1, 2002

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 22, 2003

First Submitted That Met QC Criteria

January 22, 2003

First Posted (Estimate)

January 23, 2003

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H7472-19384-8
  • DATR A4-GPS
  • R01MH063982 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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