Guided Self-Help for Functional Neurological Symptoms

NCT ID: NCT01643161

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-08-31

Brief Summary

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Functional (psychogenic or somatoform) symptoms are commonly observed in neurology clinics. There is no known empirically validated treatment approach to functional symptoms. Cognitive Behavioral Therapy (CBT) can be effective, but there are major obstacles to its provision. The investigators will test the hypothesis that adding a CBT-based guided self-help (GSH) as compared to treatment as usual (TAU) improves patient outcomes.

Detailed Description

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Conditions

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Functional Neurologic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAU+GSH

Treatment As Usual plus Guided Self Help.

Group Type EXPERIMENTAL

Treatment As Usual

Intervention Type BEHAVIORAL

Communicating the diagnosis to the patient's primary care doctor and neurologist. May include referrals for physical therapy or psychiatric evaluations, or referrals to community therapists or doctors.

Guided Self-Help

Intervention Type BEHAVIORAL

A self-help workbook based on cognitive behavioral therapy, and four half-hour guidance sessions over a three-month period.

TAU

Treatment AS Usual.

Group Type ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type BEHAVIORAL

Communicating the diagnosis to the patient's primary care doctor and neurologist. May include referrals for physical therapy or psychiatric evaluations, or referrals to community therapists or doctors.

Interventions

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Treatment As Usual

Communicating the diagnosis to the patient's primary care doctor and neurologist. May include referrals for physical therapy or psychiatric evaluations, or referrals to community therapists or doctors.

Intervention Type BEHAVIORAL

Guided Self-Help

A self-help workbook based on cognitive behavioral therapy, and four half-hour guidance sessions over a three-month period.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adult neurology outpatient with functional symptoms not largely explained by neurologic disease.

Exclusion Criteria

* Unable to use the Guided Self-Help intervention, such as due to significant cognitive impairment or unable to comprehend English.
* Requires specialist psychiatric care.
* Has headache as the only symptom.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kari A. Martin

MD PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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11-005721

Identifier Type: -

Identifier Source: org_study_id