Guided Self-Help for Functional Neurological Symptoms
This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Kari A. Martin, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01643161
First received: July 16, 2012
Last updated: January 31, 2013
Last verified: January 2013
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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 |
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.
| Estimated Enrollment: | 130 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | April 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643161
Locations
| United States, Arizona | |
| Mayo Clinic | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Contact: Travis A Johnson 480-301-4508 johnson.travis2@mayo.edu | |
| Principal Investigator: Kari A Martin, MD | |
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: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 19, 2013