Guided Self-Help for Functional Neurological Symptoms

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by (Responsible Party):
Kari A. Martin, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01643161
First received: July 16, 2012
Last updated: September 30, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Guided Self-Help for Functional Neurological Symptoms: A Randomized Controlled Efficacy Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • CGI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643161

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

No publications provided

Responsible Party: Kari A. Martin, MD PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01643161     History of Changes
Other Study ID Numbers: 11-005721
Study First Received: July 16, 2012
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014