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

March 28, 2006
March 27, 2013
March 2004
January 2008   (final data collection date for primary outcome measure)
Anxiety [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
  • Anxiety
  • Depression
  • Sleep Quality
  • Use of alcohol and other substances
Complete list of historical versions of study NCT00308724 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Functional and health status
  • Quality of life
  • Satisfaction with CBT and general health care
  • Service utilization
Not Provided
Not Provided
 
Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care
Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • 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
  • Behavioral: Telephone check-in
    Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition
  • Experimental: 1
    Cognitive Behavior Therapy
    Intervention: Behavioral: Cognitive Behavior Therapy
  • Active Comparator: 2
    Usual Care
    Intervention: Behavioral: Telephone check-in

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
148
July 2014
January 2008   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00308724
H15958, R01MH053932
No
Melinda Stanley, Baylor College of Medicine
Baylor College of Medicine
  • National Institute of Mental Health (NIMH)
  • National Institutes of Health (NIH)
  • The University of Texas Health Science Center, Houston
  • Kelsey Research Foundation
  • Kelsey-Seybold Clinic
  • VA Medical Center, Houston
Principal Investigator: Melinda A. Stanley, Ph.D. Baylor College of Medicine
Baylor College of Medicine
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP