A Randomized Controlled Trial (RCT)of Cognitive Behavioral Therapy-Telephone (CBT-T) for Late-Life Generalized Anxiety Disorder (GAD)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Generalized Anxiety Disorder
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •60 years GAD Reside in rural county Proficient in English
Exclusion Criteria
- •Current psychotherapy Active alcohol or substance abuse with use within last month Dementia or global cognitive impairment Psychotic symptoms Active suicidal ideation with plan and intent Change in psychotropic medications within last 1 month Significant hearing loss
Outcomes
Primary Outcomes
Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13
Time Frame: baseline to week 13
self-reported severity and frequency of worry the scores range from 8 to 40, with higher scores representing higher severity of worry. Higher scores represent worse outcome.
Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13
Time Frame: baseline to week 13
interviewer-rated severity of anxiety symptoms; the scores range from 0 to 56, with higher scores representing higher severity of anxiety. Higher scores represent worse outcome.
Secondary Outcomes
- Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks(baseline to week 13)
- Short Form (36) Health Survey (SF-36) to Week 13(week 13)
- Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13(baseline to week 13)
- Pepper Center Tool for Disability (PCT-D)(week 13)
- Insomnia Severity Index (ISI)(week 13)