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Original Investigation |

Multicenter Pilot Treatment Trial for Psychogenic Nonepileptic Seizures:  A Randomized Clinical Trial

W. Curt LaFrance Jr, MD, MPH1,2,3; Grayson L. Baird, MS4,5,6; John J. Barry, MD7; Andrew S. Blum, MD, PhD1; Anne Frank Webb, MA2; Gabor I. Keitner, MD3; Jason T. Machan, PhD5,6; Ivan Miller, PhD3; Jerzy P. Szaflarski, MD, PhD8,9 ; for the NES Treatment Trial (NEST-T) Consortium
[+] Author Affiliations
1Department of Neurology and Comprehensive Epilepsy Program, Rhode Island Hospital, Warren Alpert Medical School of Brown University, Providence
2Division of Neuropsychiatry and Behavioral Neurology, Rhode Island Hospital, Providence
3Department of Psychiatry, Rhode Island Hospital, Warren Albert Medical School of Brown University, Providence
4Department of Psychology, University of Rhode Island, Providence
5Department of Biostatistics, Rhode Island Hospital, Providence
6Department of Orthopedics, Brown University, Providence, Rhode Island
7Department of Psychiatry, Stanford University School of Medicine, Palo Alto, California
8Department of Neurology and Cincinnati Epilepsy Center, University of Cincinnati Academic Health Center, Cincinnati, Ohio
9now with Department of Neurology, University of Alabama at Birmingham, Birmingham
JAMA Psychiatry. 2014;71(9):997-1005. doi:10.1001/jamapsychiatry.2014.817.
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Importance  There is a paucity of controlled treatment trials for the treatment of conversion disorder, seizures type, also known as psychogenic nonepileptic seizures (PNES). Psychogenic nonepileptic seizures, the most common conversion disorder, are as disabling as epilepsy and are not adequately addressed or treated by mental health clinicians.

Objective  To evaluate different PNES treatments compared with standard medical care (treatment as usual).

Design, Setting, and Participants  Pilot randomized clinical trial at 3 academic medical centers with mental health clinicians trained to administer psychotherapy or psychopharmacology to outpatients with PNES. Thirty-eight participants were randomized in a blocked schedule among 3 sites to 1 of 4 treatment arms and were followed up for 16 weeks between September 2008 and February 2012; 34 were included in the analysis.

Interventions  Medication (flexible-dose sertraline hydrochloride) only, cognitive behavioral therapy informed psychotherapy (CBT-ip) only, CBT-ip with medication (sertraline), or treatment as usual.

Main Outcomes and Measures  Seizure frequency was the primary outcome; psychosocial and functioning measures, including psychiatric symptoms, social interactions, quality of life, and global functioning, were secondary outcomes. Data were collected prospectively, weekly, and with baseline, week 2, midpoint (week 8), and exit (week 16) batteries. Within-group analyses for each arm were performed on primary (seizure frequency) and secondary outcomes from treatment-blinded raters using an intention-to-treat analysis.

Results  The psychotherapy (CBT-ip) arm showed a 51.4% seizure reduction (P = .01) and significant improvement from baseline in secondary measures including depression, anxiety, quality of life, and global functioning (P < .001). The combined arm (CBT-ip with sertraline) showed 59.3% seizure reduction (P = .008) and significant improvements in some secondary measures, including global functioning (P = .007). The sertraline-only arm did not show a reduction in seizures (P = .08). The treatment as usual group showed no significant seizure reduction or improvement in secondary outcome measures (P = .19).

Conclusions and Relevance  This pilot randomized clinical trial for PNES revealed significant seizure reduction and improved comorbid symptoms and global functioning with CBT-ip for PNES without and with sertraline. There were no improvements in the sertraline-only or treatment-as-usual arms. This study supports the use of manualized psychotherapy for PNES and successful training of mental health clinicians in the treatment. Future studies could assess larger-scale intervention dissemination.

Trial Registration  clinicaltrials.gov Identifier: NCT00835627

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Figure 1.
CONSORT Flow Diagram of the Multisite Pilot Randomized Clinical Trial for Psychogenic Nonepileptic Seizures, Comparing Sertraline and/or Cognitive Behavioral Therapy Informed Psychotherapy (CBT-ip) With Treatment as Usual
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Figure 2.
Monthly Trajectory of Seizure Counts by Treatment Condition

Lines indicate functions of the mean weekly seizure count; shaded areas, variation corresponding to each line (treatment arm). Cognitive behavioral therapy informed psychotherapy (CBT-ip) with sertraline, P = .008; CBT-ip only, P = .01; sertraline only, P = .08; and treatment as usual, P = .19. Median time in the trial was 15 weeks, with a median range from 14 weeks in the sertraline group to 17 weeks in the group receiving CBT-ip only and the group receiving CBT-ip with sertraline.

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