Clinical trial NCT00765219: Cognitive Behavior Treatment of Older Adults With Generalized Anxiety Disorder in Primary Care
Official title: Treating Late-life GAD in Primary Care: Enhancing Outcomes and Translational Value
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
Geriatric
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-10-02
Enrollment: 222
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety
timeFrame: 18 months
Secondary outcomes:
measure: Depression
timeFrame: 18 months
measure: Sleep quality
timeFrame: 18 months
measure: Use of alcohol
timeFrame: 18 months
measure: Functional and health status
timeFrame: 18 months
measure: Quality of life
timeFrame: 18 months
measure: Pain
timeFrame: 18 months
measure: Satisfaction with CBT and general health care
timeFrame: 18 months
measure: Service utilization
timeFrame: 18 months
measure: Use of psychotropic medications
timeFrame: 18 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Center for Quality of Care and Utilization Studies
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Melinda A. Stanley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freshour JS, Amspoker AB, Yi M, Kunik ME, Wilson N, Kraus-Schuman C, Cully JA, Teng E, Williams S, Masozera N, Horsfield M, Stanley M. Cognitive behavior therapy for late-life generalized anxiety disorder delivered by lay and expert providers has lasting benefits. Int J Geriatr Psychiatry. 2016 Nov;31(11):1225-1232. doi: 10.1002/gps.4431. Epub 2016 Feb 28.
citation: Barrera TL, Cully JA, Amspoker AB, Wilson NL, Kraus-Schuman C, Wagener PD, Calleo JS, Teng EJ, Rhoades HM, Masozera N, Kunik ME, Stanley MA. Cognitive-behavioral therapy for late-life anxiety: Similarities and differences between Veteran and community participants. J Anxiety Disord. 2015 Jun;33:72-80. doi: 10.1016/j.janxdis.2015.04.005. Epub 2015 May 7.