Therapy for Depressed Elders With Thought Problems

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT00052091
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 221
• Locations: 2
• Arms: 2
• Duration (Months): 66
• Patients Per Site: 110.5
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Cognition Disorders	Behavioral: Problem Solving Therapy; Behavioral: Brief Supportive Therapy	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 221 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: PST in Geriatric Depression With Executive Dysfunction
• Study Start Date: Sep 1, 2002
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Hamilton Rating Scale for Depression [Measured at screening, weeks 1 through 12, and week 36]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of California at San Francisco	San Francisco	California	United States	94143
2	Weill Medical College of Cornell University	White Plains	New York	United States	10605

Sponsors and Collaborators

• University of Washington
• National Institute of Mental Health (NIMH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pat Arean, Professor, Psychiatry and Behavioral Sciences, University of Washington
• ClinicalTrials.gov Identifier: NCT00052091
• Other Study ID Numbers: H7472-19384-8; R01MH063982; DATR A4-GPS
• First Posted: Jan 23, 2003
• Last Update Posted: Jan 29, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Pat Arean, Professor, Psychiatry and Behavioral Sciences, University of Washington: Geriatrics
• Additional relevant MeSH terms: Depression; Cognition Disorders

Study Results

No Results Posted as of Jan 29, 2018