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Treatment of Late-life Anxiety in Primary Care Settings

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Gretchen Brenes, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00938093
First received: July 10, 2009
Last updated: April 17, 2017
Last verified: April 2017
  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 Gretchen Brenes, 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Gretchen Brenes, Associate Professor, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00938093     History of Changes
Other Study ID Numbers: MH65281
Study First Received: July 10, 2009
Last Updated: April 17, 2017

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

ClinicalTrials.gov processed this record on August 18, 2017