Cognitive Behavior Treatment of Older Adults With Generalized Anxiety Disorder in Primary Care
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Anxiety [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- 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 |
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| United States, Texas | |
| Houston Center for Quality of Care and Utilization Studies | |
| Houston, Texas, United States, 77030 | |
| 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 Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013