Clinical trial NCT01259596: Telephone Psychotherapy for Late-Life Generalized Anxiety Disorder (GAD)
Official title: A Randomized Controlled Trial (RCT)of Cognitive Behavioral Therapy-Telephone (CBT-T) for Late-Life Generalized Anxiety Disorder (GAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: anxiety
rural
elderly
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-12-14
Enrollment: 141
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13
timeFrame: baseline to week 13
measure: Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13
timeFrame: baseline to week 13
Secondary outcomes:
measure: Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks
timeFrame: baseline to week 13
measure: Pepper Center Tool for Disability (PCT-D)
timeFrame: week 13
measure: Short Form (36) Health Survey (SF-36) to Week 13
timeFrame: week 13
measure: Insomnia Severity Index (ISI)
timeFrame: week 13
measure: Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13
timeFrame: baseline to week 13
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gretchen A. Brenes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brenes GA, Danhauer SC, Lyles MF, Hogan PE, Miller ME. Telephone-Delivered Cognitive Behavioral Therapy and Telephone-Delivered Nondirective Supportive Therapy for Rural Older Adults With Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Oct;72(10):1012-20. doi: 10.1001/jamapsychiatry.2015.1154.
citation: Brenes GA, Danhauer SC, Lyles MF, Miller ME. Telephone-delivered psychotherapy for rural-dwelling older adults with generalized anxiety disorder: study protocol of a randomized controlled trial. BMC Psychiatry. 2014 Feb 8;14:34. doi: 10.1186/1471-244X-14-34.