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

Generalized Anxiety Disorder Clinical Trial

Official title:

Treating Late-life GAD in Primary Care: Enhancing Outcomes and Translational Value

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765219
• Other study ID #: H23798
• Secondary ID: R01MH053932-10A1
• Status: Completed
• Phase: N/A
• First received: October 1, 2008
• Last updated: July 21, 2015
• Start date: May 2008
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: April 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• CBT
10-12 weekly sessions of CBT in person or over the telephone.

Other:
• Usual Care
Treatment as usual provided by participants' physician(s)

Locations

Country	Name	City	State
United States	Houston Center for Quality of Care and Utilization Studies	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety		18 months	No
Secondary	Depression		18 months	No
Secondary	Sleep quality		18 months	No
Secondary	Use of alcohol		18 months	No
Secondary	Functional and health status		18 months	No
Secondary	Quality of life		18 months	No
Secondary	Pain		18 months	No
Secondary	Satisfaction with CBT and general health care		18 months	No
Secondary	Service utilization		18 months	No
Secondary	Use of psychotropic medications		18 months	No