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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598076
• Other study ID #: 2015P001152
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: June 2017

Study information

• Verified date: April 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychogenic Non-epileptic Seizures, Motivational Interviewing
• Seizures

Intervention

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.
• standard psychotherapy
Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	American Academy of Neurology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Secondary	Percent Decrease in PNES Frequency	Percent decrease in monthly PNES frequency	4 months
Secondary	Change in Number of Monthly Emergency Department Visits	Change from baseline number of Emergency Department visits per month.	4 months
Secondary	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.	4 months
Secondary	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.	4 months