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Motivational Interviewing to Enhance Adherence of Patients With Psychogenic Non-epileptic Seizures

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ClinicalTrials.gov Identifier: NCT02598076
Recruitment Status : Completed
First Posted : November 5, 2015
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
American Academy of Neurology
Information provided by (Responsible Party):
Benjamin Tolchin, Brigham and Women's Hospital

Brief Summary:

All subjects will attend an initial clinic visit with the neuropsychiatrist and epileptologist. At the end of this visit, those subjects randomized to motivational interviewing will be questioned using standardized motivational interviewing techniques by the study author who is a board certified neurologist and who will have formal training and certification in motivational interviewing.

Those subjects randomized to the control group will also undergo an initial clinic visit with a neuropsychiatrist and neurologists. However they will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.

All subjects will be contacted by phone at 3 month follow-up. If necessary they will be called 5 times at various times during the day and early evening. If they are not reached, they will receive a letter requesting them to contact the study staff to complete the study. Subjects will be questioned about their adherence to treatment. The primary outcome will be the number of psychotherapy sessions for the treatment of PNES in which they have participated over the past three months. They will also be assessed for secondary outcomes including dichotomous adherence (either seizure freedom or active participation in psychotherapy for the treatment of PNES, with more than 5 sessions over the past 3 months), seizure frequency over the past month, number of hospitalizations and emergency department visits over the past 3 months, and quality of life as measured by the brief QOLIE-10 instrument. For those patients who give permission, their psychotherapists will be contacted by study staff to confirm the exact number of psychotherapy sessions over the past 3 months. A standard Partners clinical records release form with the patient's signature will be sent to the therapist's office.


Condition or disease Intervention/treatment Phase
Psychogenic Non-epileptic Seizures, Motivational Interviewing Behavioral: motivational interviewing Behavioral: standard psychotherapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Motivational Interviewing to Enhance Adherence of Patients With Psychogenic Non-epileptic Seizures: A Model of Patient Engagement in Functional Neurological Symptom Disorders
Actual Study Start Date : August 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Active Comparator: control
Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.
Behavioral: standard psychotherapy
Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES

Experimental: MI

Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by the study author who is a board certified neurologist and who has formal training and certification in motivational interviewing.

Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference (identical treatment in control and MI arms).

Behavioral: motivational interviewing
Motivational interviews will include the classical 4 steps of MI: 1) engagement (in which the patient's goals and interests are elicited and the therapeutic alliance is established); 2) focusing (in which the specific subjects of discussion and intervention are negotiated); 3) strengthening motivation (in which the patients' reasons for healthcare intervention are made explicit, discussed, and reinforced); and 4) planning (in which actions for healthcare intervention are planned out based on the patients' own goals and interests). MI will be performed by the study author who is a board certified neurologist and who has formal training and certification in motivational interviewing.

Behavioral: standard psychotherapy
Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES




Primary Outcome Measures :
  1. Adherence [ Time Frame: 4 months ]
    Patients are classified as adherent if they attend 8 or more of the recommended 12 weekly psychotherapy sessions over a 16 week period. Otherwise they are classified as non-adherent.


Secondary Outcome Measures :
  1. Percent Decrease in PNES Frequency [ Time Frame: 4 months ]
    Percent decrease in monthly PNES frequency

  2. Change in Number of Monthly Emergency Department Visits [ Time Frame: 4 months ]
    Change from baseline number of Emergency Department visits per month.

  3. PNES Freedom [ Time Frame: 4 months ]
    Patients are classified as PNES free if they have had no PNES in 3 months, otherwise they are classified as not PNES free.

  4. Change in Quality of Life [ Time Frame: 4 months ]
    Change from baseline to 4 month follow-up, in quality of life in epilepsy (QOLIE)-10 score. Quality of Life in Epilepsy (QOLIE)-10 scale is a validated, reliable instrument measuring quality of life on a scale from 10 (best) to 50 (worst). Total score was used. No sub-scales were used.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study population will be screened from all patients diagnosed with PNES in Brigham and Women's Hospital by capture of a definitive event on video EEG without EEG correlate.
  • Patients with a mixed diagnosis of both PNES and epileptic seizures will be included.

Exclusion Criteria:

  • Pediatric patients (under age 18) are not evaluated by EEG in our hospital and will therefore be excluded
  • Estimated IQ<70
  • Active substance use disorder
  • Pregnancy or active medical issues anticipated to preclude participation in weekly psychotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598076


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
American Academy of Neurology
Investigators
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Principal Investigator: Barbara Dworetzky, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Benjamin Tolchin, Brigham and Women's Hospital:

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Responsible Party: Benjamin Tolchin, Clinical Fellow, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02598076     History of Changes
Other Study ID Numbers: 2015P001152
First Posted: November 5, 2015    Key Record Dates
Results First Posted: April 24, 2019
Last Update Posted: April 24, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms