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

Primary Purpose

Psychogenic Non-epileptic Seizures, Motivational Interviewing

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
motivational interviewing
standard psychotherapy
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychogenic Non-epileptic Seizures, Motivational Interviewing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control

MI

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Adherence
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

Percent Decrease in PNES Frequency
Percent decrease in monthly PNES frequency
Change in Number of Monthly Emergency Department Visits
Change from baseline number of Emergency Department visits per month.
PNES Freedom
Patients are classified as PNES free if they have had no PNES in 3 months, otherwise they are classified as not PNES free.
Change in Quality of Life
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.

Full Information

First Posted
November 4, 2015
Last Updated
April 22, 2019
Sponsor
Brigham and Women's Hospital
Collaborators
American Academy of Neurology
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1. Study Identification

Unique Protocol Identification Number
NCT02598076
Brief Title
Motivational Interviewing to Enhance Adherence of Patients With Psychogenic Non-epileptic Seizures
Official Title
Motivational Interviewing to Enhance Adherence of Patients With Psychogenic Non-epileptic Seizures: A Model of Patient Engagement in Functional Neurological Symptom Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
American Academy of Neurology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Specific Aim: To determine whether motivational interviewing improves adherence to treatment (primary outcome), seizure frequency, healthcare usage, and quality of life (secondary outcomes). Hypothesis: A brief in-person interview, using motivational interviewing techniques in addition to standard psychotherapy, will improve adherence, seizure frequency, healthcare usage, and quality of life at 6-month follow-up among patients with PNES when compared to a control group receiving only standard psychotherapy. Baseline demographic data, psychiatric comorbidities, seizure frequency, quality of life, and healthcare resource utilization will be recorded following enrollment during the inpatient stay as part of PHRC IRB protocol 2013P000133. If the patient is not enrolled in protocol 2013P000133, baseline demographic data, seizure data, psychiatric comorbidities, qualities of life and healthcare resource utilization will be collected during the admission at which the patient is diagnosed. All enrolled subjects will be scheduled for an initial appointment in the joint psychiatry-neurology clinic with a board certified neuropsychiatrist and board certified neurologists, which is standard of care for newly diagnosed PNES patients at Brigham and Women's Hospital. All subjects will attend the 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. Motivational interviews will include the classical 4 steps of MI: engagement (in which the patient's goals and interests are elicited and the therapeutic alliance is established); focusing (in which the specific subjects of discussion and intervention are negotiated); strengthening motivation (in which the patients' reasons for healthcare intervention are made explicit, discussed, and reinforced); and planning (in which actions for healthcare intervention are planned out based on the patients' own goals and interests). The initial clinic visit and subsequent interview will be recorded with the patients' consent, and blinded reviewers hired through the department of psychiatry, trained and certified in motivational interviewing, will score the audio recordings using the Motivational Interviewing Treatment Integrity code (MITI) 4.0 to assess fidelity to standardized motivational interviewing techniques. Recordings and blinded review of interviews are for the sole purpose of ensuring that the interviewer is in fact using proper interviewing techniques (ie motivational interviewing techniques for patients in the motivational interviewing arm and abstinence from motivational interviewing techniques in the control arm). Such recordings and review are recommended in motivational interviewing research. Those subjects randomized to the control group will also undergo an initial clinic visit with a neuropsychiatrist and neurologists - again recorded with the subjects' consent and scored using the MITI 4.0 to assess abstinence from motivational interviewing techniques. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychogenic Non-epileptic Seizures, Motivational Interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MI
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
motivational interviewing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
standard psychotherapy
Intervention Description
Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
Primary Outcome Measure Information:
Title
Adherence
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Percent Decrease in PNES Frequency
Description
Percent decrease in monthly PNES frequency
Time Frame
4 months
Title
Change in Number of Monthly Emergency Department Visits
Description
Change from baseline number of Emergency Department visits per month.
Time Frame
4 months
Title
PNES Freedom
Description
Patients are classified as PNES free if they have had no PNES in 3 months, otherwise they are classified as not PNES free.
Time Frame
4 months
Title
Change in Quality of Life
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Dworetzky, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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