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Guided Self-Help for Functional Neurological Symptoms

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.
 
ClinicalTrials.gov Identifier: NCT01643161
Recruitment Status : Terminated (Slow accrual.)
First Posted : July 18, 2012
Last Update Posted : October 1, 2013
Sponsor:
Information provided by (Responsible Party):
Kari A. Martin, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE July 16, 2012
First Posted Date  ICMJE July 18, 2012
Last Update Posted Date October 1, 2013
Study Start Date  ICMJE April 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
CGI [ Time Frame: 3 months ]
Clinical Global Improvement scale score (much worse, worse, same, better, much better) rated by the patient.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Guided Self-Help for Functional Neurological Symptoms
Official Title  ICMJE Guided Self-Help for Functional Neurological Symptoms: A Randomized Controlled Efficacy Trial
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Functional Neurologic Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: TAU+GSH
    Treatment As Usual plus Guided Self Help.
    Interventions:
    • Behavioral: Treatment As Usual
    • Behavioral: Guided Self-Help
  • Active Comparator: TAU
    Treatment AS Usual.
    Intervention: Behavioral: Treatment As Usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 30, 2013)
33
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2012)
130
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01643161
Other Study ID Numbers  ICMJE 11-005721
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kari A. Martin, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mayo Clinic
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP