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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT
Usual Care
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:

  • 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

Sites / Locations

  • Houston Center for Quality of Care and Utilization Studies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

CBT with ACS

CBT with Counselor

Usual Care

Outcomes

Primary Outcome Measures

Anxiety

Secondary Outcome Measures

Depression
Sleep quality
Use of alcohol
Functional and health status
Quality of life
Pain
Satisfaction with CBT and general health care
Service utilization
Use of psychotropic medications

Full Information

First Posted
October 1, 2008
Last Updated
July 21, 2015
Sponsor
Baylor College of Medicine
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00765219
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2013 (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)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
222 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CBT with ACS
Arm Title
2
Arm Type
Experimental
Arm Description
CBT with Counselor
Arm Title
3
Arm Type
Active Comparator
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
Cognitive Behavior Treatment, Cognitive Behavior Therapy
Intervention Description
10-12 weekly sessions of CBT in person or over the telephone.
Intervention Type
Other
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Treatment as Usual
Intervention Description
Treatment as usual provided by participants' physician(s)
Primary Outcome Measure Information:
Title
Anxiety
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Depression
Time Frame
18 months
Title
Sleep quality
Time Frame
18 months
Title
Use of alcohol
Time Frame
18 months
Title
Functional and health status
Time Frame
18 months
Title
Quality of life
Time Frame
18 months
Title
Pain
Time Frame
18 months
Title
Satisfaction with CBT and general health care
Time Frame
18 months
Title
Service utilization
Time Frame
18 months
Title
Use of psychotropic medications
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda A. Stanley, PhD
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
26923925
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.
Results Reference
derived
PubMed Identifier
26005839
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.
Results Reference
derived

Learn more about this trial

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

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