Trials / Completed
CompletedNCT01259596
Telephone Psychotherapy for Late-Life Generalized Anxiety Disorder (GAD)
A Randomized Controlled Trial (RCT)of Cognitive Behavioral Therapy-Telephone (CBT-T) for Late-Life Generalized Anxiety Disorder (GAD)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if cognitive-behavioral therapy (CBT)and supportive therapy delivered by telephone are effective for reducing worry and anxiety in rural older adults with Generalized Anxiety Disorder (GAD).
Detailed description
Older adults in rural locations often face significant barriers to treatment, including stigma, transportation, lack of local appropriately trained service providers, and impaired mobility. The proposed treatment is delivered in a workbook format and by telephone, which maximizes its portability. Treatment will be compared with nondirective supportive therapy, a very credible comparison condition equivalent to the intervention in therapist attention. We propose to randomize 88 adults ≥ 60 years with a diagnosis of GAD to either cognitive behavioral therapy delivered by telephone, or nondirective supportive therapy. The 2 primary treatment outcomes are anxiety symptoms as assessed by the Hamilton Anxiety Rating Scale, and worry symptoms as assessed by the Penn State Worry Questionnaire-Abbreviated. The proposed secondary outcomes are depressive symptoms, sleep, disability, and quality of life. Further, mediators and moderators of the treatment effect will also be examined. Mediators include process variables (therapeutic alliance, adherence, participant satisfaction, and treatment credibility) and new psychotropic medication use; moderators include demographic information (age, education, gender, race, income), psychiatric variables (baseline anxiety severity, baseline depressive disorders, baseline psychotropic medication use), medical comorbidity, and therapist assignment. Maintenance of response will be assessed over 6 months. This research has great public health significance, because it is a low-cost intervention with high potential for widespread dissemination, and it targets an underserved group - community-dwelling rural elders - who currently lack effective treatment interventions tailored to their needs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | cognitive behavioral therapy | weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions |
| BEHAVIORAL | nondirective supportive therapy | weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2010-12-14
- Last updated
- 2018-08-29
- Results posted
- 2017-10-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01259596. Inclusion in this directory is not an endorsement.