Telephone Psychotherapy for Late-Life Generalized Anxiety Disorder (GAD)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-02-28

Brief Summary

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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).

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Detailed Description

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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

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive behavioral therapy

Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention

Group Type ACTIVE_COMPARATOR

cognitive behavioral therapy

Intervention Type BEHAVIORAL

weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions

Nondirective supportive therapy

Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings

Group Type ACTIVE_COMPARATOR

nondirective supportive therapy

Intervention Type BEHAVIORAL

weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions

Interventions

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cognitive behavioral therapy

weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions

Intervention Type BEHAVIORAL

nondirective supportive therapy

weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT NST

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No