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Guided Self-Help for Functional Neurological Symptoms

Guided Self-Help for Functional Neurological Symptoms: A Randomized Controlled Efficacy Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01643161
Enrollment
33
Registered
2012-07-18
Start date
2012-04-30
Completion date
2013-08-31
Last updated
2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Neurologic Disease

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.

Interventions

BEHAVIORALTreatment 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.

A self-help workbook based on cognitive behavioral therapy, and four half-hour guidance sessions over a three-month period.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CGI3 monthsClinical Global Improvement scale score (much worse, worse, same, better, much better) rated by the patient.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026