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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
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

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

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

    First Posted
    July 10, 2009
    Last Updated
    August 9, 2018
    Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Institute of Mental Health (NIMH)
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    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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