Guided Self-Help for Functional Neurological Symptoms

Guided Self-Help for Functional Neurological Symptoms: A Randomized Controlled Efficacy Trial

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.

Study Overview

• Status: Terminated
• Conditions: Functional Neurologic Disease
• Intervention / Treatment: Behavioral: Treatment As Usual; Behavioral: Guided Self-Help

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAU+GSH; Treatment As Usual plus Guided Self Help.	Behavioral: 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.; Behavioral: Guided Self-Help; A self-help workbook based on cognitive behavioral therapy, and four half-hour guidance sessions over a three-month period.
Active Comparator: TAU; Treatment AS Usual.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGI	Clinical Global Improvement scale score (much worse, worse, same, better, much better) rated by the patient.	3 months

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Estimate): October 1, 2013
• Last Update Submitted That Met QC Criteria: September 30, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 11-005721