Functional Neurologic Disease Clinical Trial
Official title:
Guided Self-Help for Functional Neurological Symptoms: A Randomized Controlled Efficacy Trial
| Verified date | September 2013 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 33 |
| Est. completion date | August 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic | Scottsdale | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CGI | Clinical Global Improvement scale score (much worse, worse, same, better, much better) rated by the patient. | 3 months | No |