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Nocebo-Hypothesis Cognitive Behavioral Therapy (NH-CBT) for Persons With Functional Neurological Symptoms (Motor Type): Design and Implementation of a Randomized Active-Controlled Trial

journal contribution
posted on 18.01.2021, 02:38 by M Richardson, M Kleinstäuber, Dana Wong
© Copyright © 2020 Richardson, Kleinstäuber and Wong. Introduction: Functional Neurological Symptom Disorders (FNSD) are associated with high levels of disability and immense direct and indirect health costs. An innovative interdisciplinary rehabilitation approach for individuals with functional neurological symptoms of motor type–Nocebo-Hypothesis Cognitive Behavioral Therapy (NH-CBT)—combines CBT and movement retraining with video feedback embedded in a comprehensive explanatory model of the etiology of FNSD. Methods: This protocol describes the development and implementation of a phase II, parallel group, randomized controlled trial with blinded outcome assessors to compare the efficacy of NH-CBT with an active control condition (supportive counseling and movement retraining). Individuals meeting diagnostic criteria of an FNSD or psychogenic movement disorder will be randomly assigned to one of the 8-week interventions. Self-report scales of motor and other physical symptoms, symptom-related psychological variables, and assessor ratings of participants' mobility will be administered at baseline, and at 8- and 16-week follow-up. Adverse events will be monitored across all sessions and therapeutic alliance will be measured at the end of therapy. The primary statistical analysis will test the hypothesis that NH-CBT is more effective than the control intervention at the 8-week follow-up. Discussion: The therapeutic strategies of NH-CBT are theory-driven by assumptions of the predictive coding model of the etiology of FNSD. Strengths and limitations of this trial will be discussed. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR; identifier: ACTRN12620000550909).

Funding

This work was supported by the Health Research Council of New Zealand (HRC) [Biomedical and Public Health Career Development Award, grant numbers 20/045]. The funder of the study has had no role in study design and will have no role in data collection, data analysis, data interpretation, writing of the report, or decision to submit the paper for publication.

History

Publication Date

07/12/2020

Journal

Frontiers in Neurology

Volume

11

Article Number

ARTN 586359

Pagination

14p.

Publisher

FRONTIERS MEDIA SA

ISSN

1664-2295

Rights Statement

The Author reserves all moral rights over the deposited text and must be credited if any re-use occurs. Documents deposited in OPAL are the Open Access versions of outputs published elsewhere. Changes resulting from the publishing process may therefore not be reflected in this document. The final published version may be obtained via the publisher’s DOI. Please note that additional copyright and access restrictions may apply to the published version.