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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00052091
Other study ID # H7472-19384-8
Secondary ID R01MH063982DATR
Status Completed
Phase Phase 3
First received January 22, 2003
Last updated January 25, 2018
Start date September 2002
Est. completion date March 2008

Study information

Verified date January 2018
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 221
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Nonpsychotic, unipolar major depression

- Cognitive impairment

- English speaking

Exclusion Criteria:

- High suicide risk

- Dementia

- Acute or severe medical illness

- Current psychotherapy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Problem Solving Therapy
A 12 week cognitive behavioral intervention for depression that teaches patients a structured approach to solving social problems.
Brief Supportive Therapy
A 12 week intervention for depression that focuses on supporting patients attempts to cope with depression.

Locations

Country Name City State
United States University of California at San Francisco San Francisco California
United States Weill Medical College of Cornell University White Plains New York

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Alexopoulos GS, Raue PJ, Kiosses DN, Mackin RS, Kanellopoulos D, McCulloch C, Areán 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( — View Citation

Areán 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Rating Scale for Depression Measured at screening, weeks 1 through 12, and week 36
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