Psychogenic Non-epileptic Seizures, Motivational Interviewing Clinical Trial
Official title:
Motivational Interviewing to Enhance Adherence of Patients With Psychogenic Non-epileptic Seizures: A Model of Patient Engagement in Functional Neurological Symptom Disorders
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.
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.
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