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Therapy for Depressed Elders With Thought Problems

Primary Purpose

Depression, Cognition Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Problem Solving Therapy
Brief Supportive Therapy
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria: Nonpsychotic, unipolar major depression Cognitive impairment English speaking Exclusion Criteria: High suicide risk Dementia Acute or severe medical illness Current psychotherapy

Sites / Locations

  • University of California at San Francisco
  • Weill Medical College of Cornell University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1 Problem Solving Therapy

2 Brief Supportive Therapy

Arm Description

12 weekly sessions of problem solving therapy (PST)

12 weekly sessions of brief supportive therapy (BST)

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression

Secondary Outcome Measures

Full Information

First Posted
January 22, 2003
Last Updated
January 25, 2018
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00052091
Brief Title
Therapy for Depressed Elders With Thought Problems
Official Title
PST in Geriatric Depression With Executive Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Cognition Disorders
Keywords
Geriatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Problem Solving Therapy
Arm Type
Experimental
Arm Description
12 weekly sessions of problem solving therapy (PST)
Arm Title
2 Brief Supportive Therapy
Arm Type
Experimental
Arm Description
12 weekly sessions of brief supportive therapy (BST)
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Therapy
Intervention Description
A 12 week cognitive behavioral intervention for depression that teaches patients a structured approach to solving social problems.
Intervention Type
Behavioral
Intervention Name(s)
Brief Supportive Therapy
Intervention Description
A 12 week intervention for depression that focuses on supporting patients attempts to cope with depression.
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression
Time Frame
Measured at screening, weeks 1 through 12, and week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Nonpsychotic, unipolar major depression Cognitive impairment English speaking Exclusion Criteria: High suicide risk Dementia Acute or severe medical illness Current psychotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia A. Arean, PhD
Organizational Affiliation
University of California at San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Weill Medical College of Cornell University
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
20516155
Citation
Arean PA, Raue P, Mackin RS, Kanellopoulos D, McCulloch C, Alexopoulos GS. Problem-solving therapy and supportive therapy in older adults with major depression and executive dysfunction. Am J Psychiatry. 2010 Nov;167(11):1391-8. doi: 10.1176/appi.ajp.2010.09091327. Epub 2010 Jun 1.
Results Reference
result
PubMed Identifier
21199963
Citation
Alexopoulos GS, Raue PJ, Kiosses DN, Mackin RS, Kanellopoulos D, McCulloch C, Arean PA. Problem-solving therapy and supportive therapy in older adults with major depression and executive dysfunction: effect on disability. Arch Gen Psychiatry. 2011 Jan;68(1):33-41. doi: 10.1001/archgenpsychiatry.2010.177.
Results Reference
result
PubMed Identifier
28647669
Citation
Alexopoulos GS, O'Neil R, Banerjee S, Raue PJ, Victoria LW, Bress JN, Pollari C, Arean PA. "Engage" therapy: Prediction of change of late-life major depression. J Affect Disord. 2017 Oct 15;221:192-197. doi: 10.1016/j.jad.2017.06.037. Epub 2017 Jun 19.
Results Reference
derived
PubMed Identifier
26743100
Citation
Gustavson KA, Alexopoulos GS, Niu GC, McCulloch C, Meade T, Arean PA. Problem-Solving Therapy Reduces Suicidal Ideation In Depressed Older Adults with Executive Dysfunction. Am J Geriatr Psychiatry. 2016 Jan;24(1):11-17. doi: 10.1016/j.jagp.2015.07.010. Epub 2015 Jul 30.
Results Reference
derived
PubMed Identifier
25081818
Citation
Alexopoulos GS, Raue PJ, Kiosses DN, Seirup JK, Banerjee S, Arean PA. Comparing engage with PST in late-life major depression: a preliminary report. Am J Geriatr Psychiatry. 2015 May;23(5):506-13. doi: 10.1016/j.jagp.2014.06.008. Epub 2014 Jun 26.
Results Reference
derived

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Therapy for Depressed Elders With Thought Problems

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