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Guided Self-Help for Functional Neurological Symptoms

This study has been terminated.
(Slow accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643161
First Posted: July 18, 2012
Last Update Posted: October 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kari A. Martin, Mayo Clinic
  Purpose
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.

Condition Intervention
Functional Neurologic Disease Behavioral: Treatment As Usual Behavioral: Guided Self-Help

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Guided Self-Help for Functional Neurological Symptoms: A Randomized Controlled Efficacy Trial

Further study details as provided by Kari A. Martin, Mayo Clinic:

Primary Outcome Measures:
  • CGI [ Time Frame: 3 months ]
    Clinical Global Improvement scale score (much worse, worse, same, better, much better) rated by the patient.


Enrollment: 33
Study Start Date: April 2012
Study Completion Date: August 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643161


Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
  More Information

Responsible Party: Kari A. Martin, MD PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01643161     History of Changes
Other Study ID Numbers: 11-005721
First Submitted: July 16, 2012
First Posted: July 18, 2012
Last Update Posted: October 1, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Nervous System Diseases