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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melinda Stanley, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00765219
First received: October 1, 2008
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Generalized Anxiety Disorder
Behavioral: CBT
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treating Late-life GAD in Primary Care: Enhancing Outcomes and Translational Value

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Anxiety [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Use of alcohol [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Functional and health status [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Satisfaction with CBT and general health care [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Service utilization [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Use of psychotropic medications [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 222
Study Start Date: May 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CBT with ACS
Behavioral: CBT
10-12 weekly sessions of CBT in person or over the telephone.
Other Name: Cognitive Behavior Treatment, Cognitive Behavior Therapy
Experimental: 2
CBT with Counselor
Behavioral: CBT
10-12 weekly sessions of CBT in person or over the telephone.
Other Name: Cognitive Behavior Treatment, Cognitive Behavior Therapy
Active Comparator: 3
Usual Care
Other: Usual Care
Treatment as usual provided by participants' physician(s)
Other Name: Treatment as Usual

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765219

Locations
United States, Texas
Houston Center for Quality of Care and Utilization Studies
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Melinda A. Stanley, PhD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Melinda Stanley, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00765219     History of Changes
Other Study ID Numbers: H23798, R01MH053932-10A1
Study First Received: October 1, 2008
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Generalized Anxiety Disorder
Geriatric

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

ClinicalTrials.gov processed this record on November 25, 2014