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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: CBT; Other: Usual Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Center for Quality of Care and Utilization Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; CBT with ACS	Behavioral: CBT; 10-12 weekly sessions of CBT in person or over the telephone.; Other Names: Cognitive Behavior Treatment, Cognitive Behavior Therapy
Experimental: 2; CBT with Counselor	Behavioral: CBT; 10-12 weekly sessions of CBT in person or over the telephone.; Other Names: Cognitive Behavior Treatment, Cognitive Behavior Therapy
Active Comparator: 3; Usual Care	Other: Usual Care; Treatment as usual provided by participants' physician(s); Other Names: Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anxiety	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Depression	18 months
Sleep quality	18 months
Use of alcohol	18 months
Functional and health status	18 months
Quality of life	18 months
Pain	18 months
Satisfaction with CBT and general health care	18 months
Service utilization	18 months
Use of psychotropic medications	18 months

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Melinda A. Stanley, PhD, Baylor College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 21, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Generalized Anxiety Disorder; Geriatric
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: H23798; R01MH053932-10A1 (U.S. NIH Grant/Contract)