Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cognitive Behavior Treatment of Older Adults With Generalized Anxiety Disorder in Primary Care

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Melinda Stanley, Baylor College of Medicine Identifier:
First received: October 1, 2008
Last updated: January 27, 2015
Last verified: January 2015

October 1, 2008
January 27, 2015
May 2008
December 2013   (final data collection date for primary outcome measure)
Anxiety [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00765219 on Archive Site
  • Depression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Use of alcohol [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Functional and health status [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Satisfaction with CBT and general health care [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Service utilization [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Use of psychotropic medications [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
Cognitive Behavior Treatment of Older Adults With Generalized Anxiety Disorder in Primary Care
Treating Late-life GAD in Primary Care: Enhancing Outcomes and Translational Value

The purpose of this study is to determine whether cognitive behavior treatment (CBT) can be delivered effectively by providers of different expertise levels 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 in later life. Given the potential difficulties in prescribing psychotropic medications in later life(e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternatives or adjuncts.

The treatment phase of this study lasts 6 months, during which patients will be randomly assigned to either cognitive behavior treatment (CBT) with an Anxiety Clinic Specialist (ACS) or Counselor or to Usual Care (UC). All participants will complete telephone assessments at baseline, 1, 2, and 3 months during the treatment phase. During the first 12 weeks, those assigned to CBT will also complete 10-12 weekly sessions, either in person or over the telephone. During the second 12 weeks, CBT patients will receive follow-up telephone booster calls, weekly for the first 4 weeks and biweekly for the last 8 weeks. During the treatment phase, UC participants will receive no treatment from study clinicians but will continue to receive their usual care from their current medical providers.

At 6 months, all participants will complete a telephone assessment. CBT patients will enter a one year follow-up period, with telephone assessments at 12 and 18 months. UC participants will be offered the option to receive brief CBT after completion of the 6 month telephone assessment. Those who choose to participate in CBT will complete telephone assessments at 9 and 12 months.

Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Behavioral: CBT
    10-12 weekly sessions of CBT in person or over the telephone.
    Other Name: Cognitive Behavior Treatment, Cognitive Behavior Therapy
  • Other: Usual Care
    Treatment as usual provided by participants' physician(s)
    Other Name: Treatment as Usual
  • Experimental: 1
    CBT with ACS
    Intervention: Behavioral: CBT
  • Experimental: 2
    CBT with Counselor
    Intervention: Behavioral: CBT
  • Active Comparator: 3
    Usual Care
    Intervention: Other: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
April 2015
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 60 and older
  • Principal or Co-principal GAD diagnosis
  • Patient at participating clinic

Exclusion Criteria:

  • Active suicidal intent
  • Current psychosis or bipolar disorder
  • Substance abuse within the past month
  • Cognitive impairment according to a Mini Cog screener score of 3 or lower
60 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
H23798, R01MH053932-10A1
Melinda Stanley, Baylor College of Medicine
Baylor College of Medicine
National Institute of Mental Health (NIMH)
Principal Investigator: Melinda A. Stanley, PhD Baylor College of Medicine
Baylor College of Medicine
January 2015

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