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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavior Therapy; Behavioral: Telephone check-in

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 148
• 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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2; Usual Care	Behavioral: Telephone check-in; Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition
Experimental: 1; Cognitive Behavior Therapy	Behavioral: Cognitive Behavior Therapy; 8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period; Other Names: CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anxiety	Baseline and 3, 6, 9, 12 and 15 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional and health status	Baseline and 3, 6, 9, 12 and 15 months
Satisfaction with CBT and general health care	Baseline and 3, 6, 9, 12 and 15 months
Service utilization	Baseline and 3, 6, 9, 12 and 15 months
Depression	Baseline and 3, 6, 9, 12 and 15 months
Sleep quality	Baseline and 3, 6, 9, 12 and 15 months
Use of alcohol and other substances	Baseline and 3, 6, 9, 12 and 15 months
Quality of life inventory (QOLI)	Baseline and 3, 6, 9, 12 and 15 months

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: National Institute of Mental Health (NIMH); The University of Texas Health Science Center, Houston; National Institutes of Health (NIH); Michael E. DeBakey VA Medical Center; Kelsey-Seybold Clinic; Kelsey Research Foundation
• Investigators: Principal Investigator: Melinda A. Stanley, Ph.D., Baylor College of Medicine

Publications and helpful links

General Publications

• Wetherell JL, Lenze EJ, Stanley MA. Evidence-based treatment of geriatric anxiety disorders. Psychiatr Clin North Am. 2005 Dec;28(4):871-96, ix. doi: 10.1016/j.psc.2005.09.006. No abstract available.
• Stanley MA, Kunik ME. Anxiety in primary care: a frontier for mental health services research. Med Care. 2005 Dec;43(12):1161-3. doi: 10.1097/01.mlr.0000190923.04095.80. No abstract available.
• Stanley MA, Hopko DR, Diefenbach GJ, Bourland SL, Rodriguez H, Wagener P. Cognitive-behavior therapy for late-life generalized anxiety disorder in primary care: preliminary findings. Am J Geriatr Psychiatry. 2003 Jan-Feb;11(1):92-6.
• Shrestha S, Stanley MA, Wilson NL, Cully JA, Kunik ME, Novy DM, Rhoades HM, Amspoker AB. Predictors of change in quality of life in older adults with generalized anxiety disorder. Int Psychogeriatr. 2015 Jul;27(7):1207-15. doi: 10.1017/S1041610214002567. Epub 2014 Dec 12.
• Stanley MA, Wilson NL, Novy DM, Rhoades HM, Wagener PD, Greisinger AJ, Cully JA, Kunik ME. Cognitive behavior therapy for generalized anxiety disorder among older adults in primary care: a randomized clinical trial. JAMA. 2009 Apr 8;301(14):1460-7. doi: 10.1001/jama.2009.458.

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: March 28, 2006
• First Submitted That Met QC Criteria: March 28, 2006
• First Posted (Estimated): March 30, 2006

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Generalized Anxiety Disorder; Geriatric
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: H15958; R01MH053932 (U.S. NIH Grant/Contract)