Treatment of Late-life Anxiety in Primary Care Settings
Primary Purpose
Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorder Not Otherwise Specified
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Enhanced usual care
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
Eligibility Criteria
Inclusion Criteria:
- age ≥ 60 years
- a DSM-IV diagnosis of GAD
- able to read English.
Exclusion Criteria:
- current psychotherapy
- a DSM-IV diagnosis of alcohol or substance abuse
- a diagnosis of dementia or global cognitive impairment operationalized as a score of < 24 of the Mini-Mental Status Examination
- psychotic symptoms
- active suicidal ideation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cognitive-behavioral therapy
Enhanced usual care
Arm Description
cognitive-behavioral therapy
enhanced usual care
Outcomes
Primary Outcome Measures
PSWQ-A
HAM-A
Secondary Outcome Measures
Full Information
NCT ID
NCT00938093
First Posted
July 10, 2009
Last Updated
August 9, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00938093
Brief Title
Treatment of Late-life Anxiety in Primary Care Settings
Official Title
Treatment of Late-life Anxiety in Primary Care Settings
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The research study proposed is designed to examine the outcomes of a cognitive behavioral guided self-care intervention with older adults diagnosed with generalized anxiety disorder and recruited from a primary care setting. It is hypothesized that the cognitive behavioral guided self-care intervention will produce greater declines in worry and anxiety than enhanced usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorder Not Otherwise Specified
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavioral therapy
Arm Type
Active Comparator
Arm Description
cognitive-behavioral therapy
Arm Title
Enhanced usual care
Arm Type
Placebo Comparator
Arm Description
enhanced usual care
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
Participants receive 10 telephone therapy sessions and an accompanying workbook focused on cognitive-behavioral techniques for managing anxiety.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care
Intervention Description
Participants receive written information about anxiety, referrals for treatment, and an optional letter to their primary care physician.
Primary Outcome Measure Information:
Title
PSWQ-A
Time Frame
4 months
Title
HAM-A
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 60 years
a DSM-IV diagnosis of GAD
able to read English.
Exclusion Criteria:
current psychotherapy
a DSM-IV diagnosis of alcohol or substance abuse
a diagnosis of dementia or global cognitive impairment operationalized as a score of < 24 of the Mini-Mental Status Examination
psychotic symptoms
active suicidal ideation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen Brenes, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Treatment of Late-life Anxiety in Primary Care Settings
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