Clinical trial NCT02598076: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psychogenic Non-epileptic Seizures, Motivational Interviewing
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: American Academy of Neurology
First posted: 2015-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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).

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.

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

Primary outcomes:
measure: Adherence
timeFrame: 4 months
Secondary outcomes:
measure: Percent Decrease in PNES Frequency
timeFrame: 4 months
measure: Change in Number of Monthly Emergency Department Visits
timeFrame: 4 months
measure: PNES Freedom
timeFrame: 4 months
measure: Change in Quality of Life
timeFrame: 4 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Barbara Dworetzky, MD
role: PRINCIPAL_INVESTIGATOR
References: