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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The University of Texas Health Science Center, Houston
Kelsey Research Foundation
Kelsey-Seybold Clinic
VA Medical Center, Houston
Information provided by (Responsible Party):
Melinda Stanley, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00308724
First received: March 28, 2006
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Behavioral: Cognitive Behavior Therapy
Behavioral: Telephone check-in
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: Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

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

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 ]

Enrollment: 148
Study Start Date: March 2004
Estimated Study Completion Date: July 2014
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cognitive Behavior Therapy
Behavioral: Cognitive Behavior Therapy
8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period
Other Name: CBT
Active Comparator: 2
Usual Care
Behavioral: Telephone check-in
Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00308724

Locations
United States, Texas
Houston Center for Quality of Care and Utilization Studies
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Melinda Stanley, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00308724     History of Changes
Obsolete Identifiers: NCT00081393
Other Study ID Numbers: H15958, R01MH053932
Study First Received: March 28, 2006
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Generalized Anxiety Disorder
Geriatric

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014