Therapy for Depressed Elders With Thought Problems

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00052091
First received: January 22, 2003
Last updated: September 20, 2013
Last verified: September 2013
  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

Further study details as provided by University of California, San Francisco:

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 ]

Enrollment: 221
Study Start Date: September 2002
Study Completion Date: March 2008
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of California, San Francisco
Investigators
Principal Investigator: Patricia A. Arean, PhD University of California at San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00052091     History of Changes
Other Study ID Numbers: R01 MH063982, R01MH063982, DATR A4-GPS
Study First Received: January 22, 2003
Last Updated: September 20, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Geriatrics

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

ClinicalTrials.gov processed this record on October 19, 2014