NCT01643161

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

10 months

First QC Date

July 16, 2012

Last Update Submit

September 30, 2013

Conditions

Functional Neurologic Disease

Outcome Measures

Primary Outcomes (1)

  • CGI

    Clinical Global Improvement scale score (much worse, worse, same, better, much better) rated by the patient.

    3 months

Study Arms (2)

TAU+GSH

EXPERIMENTAL

Treatment As Usual plus Guided Self Help.

Behavioral: Treatment As UsualBehavioral: Guided Self-Help

TAU

ACTIVE COMPARATOR

Treatment AS Usual.

Behavioral: Treatment As Usual

Interventions

Treatment As UsualBEHAVIORAL

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.

TAUTAU+GSH
Guided Self-HelpBEHAVIORAL

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

TAU+GSH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult neurology outpatient with functional symptoms not largely explained by neurologic disease.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PI

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 18, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2013

Study Completion

August 1, 2013

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

US(1)