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Treatment of Late-life Anxiety in Primary Care Settings

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938093
First Posted: July 13, 2009
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention
Generalized Anxiety Disorder Panic Disorder Anxiety Disorder Not Otherwise Specified Behavioral: Cognitive behavioral therapy Behavioral: Enhanced usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Late-life Anxiety in Primary Care Settings

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • PSWQ-A [ Time Frame: 4 months ]
  • HAM-A [ Time Frame: 4 months ]

Enrollment: 60
Study Start Date: March 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive-behavioral therapy
cognitive-behavioral therapy
Behavioral: Cognitive behavioral therapy
Participants receive 10 telephone therapy sessions and an accompanying workbook focused on cognitive-behavioral techniques for managing anxiety.
Placebo Comparator: Enhanced usual care
enhanced usual care
Behavioral: Enhanced usual care
Participants receive written information about anxiety, referrals for treatment, and an optional letter to their primary care physician.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938093


Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Gretchen Brenes, PhD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00938093     History of Changes
Other Study ID Numbers: MH65281
First Submitted: July 10, 2009
First Posted: July 13, 2009
Last Update Posted: November 8, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Panic Disorder
Pathologic Processes
Mental Disorders