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Therapy for Depressed Elders With Thought Problems

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00052091
First received: January 22, 2003
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Depression
Cognition Disorders
 Behavioral: Problem Solving Therapy
Behavioral: Brief Supportive Therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PST in Geriatric Depression With Executive Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: Measured at screening, weeks 1 through 12, and week 36 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: September 2002
Estimated Study Completion Date: March 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • High suicide risk
  • Dementia
  • Acute or severe medical illness
  • Current psychotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052091

Locations
United States, California
University of California at San Francisco
San Francisco, California, United States, 94143
United States, New York
Weill Medical College of Cornell University
White Plains, New York, United States, 10605
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Patricia A. Arean, PhD University of California at San Francisco
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: George S. Alexopoulos, MD, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00052091     History of Changes
Other Study ID Numbers: R01 MH063982, DATR A4-GPS
Study First Received: January 22, 2003
Last Updated: August 3, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Geriatrics

Additional relevant MeSH terms:
Cognition Disorders
Depression
Depressive Disorder
Delirium, Dementia, Amnestic, Cognitive Disorders
 Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 16, 2013