Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 28, 2006

Last Updated Date

October 30, 2008

Start Date ^†

March 2004

Current Primary Outcome Measures ^†

Anxiety [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Anxiety
Depression
Sleep Quality
Use of alcohol and other substances

Change History

Complete list of historical versions of study NCT00308724 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Functional and health status [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Satisfaction with CBT and general health care [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Service utilization [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Depression [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Sleep quality [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Use of alcohol and other substances [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Functional and health status
Quality of life
Satisfaction with CBT and general health care
Service utilization

Descriptive Information

Brief Title ^†

Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care

Official Title ^†

Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care

Brief Summary

The purpose of this study is to determine whether cognitive behavior therapy (CBT) is effective in the treatment of generalized anxiety disorder (GAD) in adults age 60 and older in a primary care setting.

Detailed Description

Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders among older adults. Anxiety in older adults is associated with decreased physical activity, poorer self-perceptions of health, decreased life satisfaction, and increased loneliness. Because many older adults with anxiety seek assistance in a medical setting, treatment has been primarily pharmacological. There is, however, limited evidence of the effectiveness of psychotropic medications. Given the potential difficulties in prescribing psychotropic medications in later life (e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternative or adjuncts.

The treatment phase of this study lasts 10 weeks, during which patients will be randomly assigned to either cognitive behavior therapy (CBT) or usual care. Follow-up will last 12 months after treatment completion, during which time patients will complete telephone assessments.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study

Condition ^†

Generalized Anxiety Disorder

Intervention ^†

Behavioral: Cognitive Behavior Therapy
Behavioral: Telephone check-in

Study Arms / Comparison Groups

Experimental: Cognitive Behavior Therapy
Active Comparator: Usual Care

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

148

Estimated Completion Date

July 2009

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Clinical diagnosis of Generalized Anxiety Disorder

Exclusion Criteria:

Active suicidal intent
Current psychosis
Current bipolar disorder
Substance abuse within past month
Cognitive impairment

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00308724

Responsible Party

Melinda A. Stanley, Ph.D., Baylor College of Medicine

Secondary IDs ^††

R01-MH053932

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

National Institutes of Health (NIH)
The University of Texas Health Science Center, Houston
Kelsey Research Foundation
Kelsey-Seybold Clinic
VA Medical Center, Houston

Investigators ^†

Principal Investigator:

Melinda A. Stanley, Ph.D.

Baylor College of Medicine

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.