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Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
Telephone check-in
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder, Geriatric

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Houston Center for Quality of Care and Utilization Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Cognitive Behavior Therapy

Usual Care

Outcomes

Primary Outcome Measures

Anxiety

Secondary Outcome Measures

Functional and health status
Quality of life
Satisfaction with CBT and general health care
Service utilization
Depression
Sleep quality
Use of alcohol and other substances

Full Information

First Posted
March 28, 2006
Last Updated
July 21, 2015
Sponsor
Baylor College of Medicine
Collaborators
National Institute of Mental Health (NIMH), National Institutes of Health (NIH), The University of Texas Health Science Center, Houston, Kelsey Research Foundation, Kelsey-Seybold Clinic, Michael E. DeBakey VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00308724
Brief Title
Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care
Official Title
Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institute of Mental Health (NIMH), National Institutes of Health (NIH), The University of Texas Health Science Center, Houston, Kelsey Research Foundation, Kelsey-Seybold Clinic, Michael E. DeBakey VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Generalized Anxiety Disorder, Geriatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cognitive Behavior Therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Other Intervention Name(s)
CBT
Intervention Description
8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period
Intervention Type
Behavioral
Intervention Name(s)
Telephone check-in
Intervention Description
Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition
Primary Outcome Measure Information:
Title
Anxiety
Time Frame
Baseline and 3, 6, 9, 12 and 15 months
Secondary Outcome Measure Information:
Title
Functional and health status
Time Frame
Baseline and 3, 6, 9, 12 and 15 months
Title
Quality of life
Time Frame
Baseline and 3, 6, 9, 12 and 15 months
Title
Satisfaction with CBT and general health care
Time Frame
Baseline and 3, 6, 9, 12 and 15 months
Title
Service utilization
Time Frame
Baseline and 3, 6, 9, 12 and 15 months
Title
Depression
Time Frame
Baseline and 3, 6, 9, 12 and 15 months
Title
Sleep quality
Time Frame
Baseline and 3, 6, 9, 12 and 15 months
Title
Use of alcohol and other substances
Time Frame
Baseline and 3, 6, 9, 12 and 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda A. Stanley, Ph.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Center for Quality of Care and Utilization Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16325733
Citation
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.
Results Reference
background
PubMed Identifier
16299425
Citation
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.
Results Reference
background
PubMed Identifier
12527544
Citation
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.
Results Reference
background
PubMed Identifier
25497362
Citation
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.
Results Reference
derived
PubMed Identifier
19351943
Citation
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.
Results Reference
derived

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Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care

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