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

Motivational Interviewing to Enhance Adherence of Patients With Psychogenic Non-epileptic Seizures: A Model of Patient Engagement in Functional Neurological Symptom Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02598076
Enrollment
60
Registered
2015-11-05
Start date
2015-08-31
Completion date
2017-06-30
Last updated
2019-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychogenic Non-epileptic Seizures, Motivational Interviewing

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.

Interventions

BEHAVIORALmotivational 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 cognitive behavioral therapy based psychotherapy for the treatment of PNES

Sponsors

American Academy of Neurology
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence4 monthsPatients 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

MeasureTime frameDescription
Percent Decrease in PNES Frequency4 monthsPercent decrease in monthly PNES frequency
Change in Number of Monthly Emergency Department Visits4 monthsChange from baseline number of Emergency Department visits per month.
PNES Freedom4 monthsPatients 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 Life4 monthsChange 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
31
Motivational Interviewing
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 a board certified neurologist with 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 BWH or referred to a local psychotherapist according to their preference. motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning. standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
29
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up23

Baseline characteristics

CharacteristicControlMotivational InterviewingTotal
Age, Continuous40.7 years
STANDARD_DEVIATION 14.3
39.6 years
STANDARD_DEVIATION 16.8
40.2 years
STANDARD_DEVIATION 15.4
delay to diagnosis of PNES3 months9 months7 months
Emergency Department visits per month1 visits per month1 visits per month1 visits per month
generalized anxiety disorder19 Participants15 Participants34 Participants
History of abuse
any abuse
18 Participants18 Participants36 Participants
History of abuse
emotional abuse
11 Participants11 Participants22 Participants
History of abuse
physical abuse
11 Participants11 Participants22 Participants
History of abuse
sexual abuse
15 Participants13 Participants28 Participants
household income42000 dollars30000 dollars33000 dollars
major depressive disorder13 Participants12 Participants25 Participants
Post traumatic stress disorder10 Participants12 Participants22 Participants
psychogenic seizure frequency3 PNES per week4 PNES per week4 PNES per week
Quality of Life in Epilepsy (QOLIE)-1028.0 units on a scale
STANDARD_DEVIATION 9.5
28.4 units on a scale
STANDARD_DEVIATION 8.8
28.2 units on a scale
STANDARD_DEVIATION 9
Race/Ethnicity, Customized
African-American
3 Participants3 Participants6 Participants
Race/Ethnicity, Customized
Hispanic
7 Participants6 Participants13 Participants
Race/Ethnicity, Customized
Other
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White, non-Hispanic
20 Participants20 Participants40 Participants
referred to psychotherapy at Brigham and Women's Hospital17 Participants13 Participants30 Participants
Region of Enrollment
United States
31 participants29 participants60 participants
Sex: Female, Male
Female
26 Participants23 Participants49 Participants
Sex: Female, Male
Male
5 Participants6 Participants11 Participants
years of education13.8 years
STANDARD_DEVIATION 2.5
13.0 years
STANDARD_DEVIATION 2.7
13.4 years
STANDARD_DEVIATION 2.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 29
other
Total, other adverse events
0 / 310 / 29
serious
Total, serious adverse events
0 / 310 / 29

Outcome results

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.

Time frame: 4 months

Population: Analysis population includes all participants for whom follow-up data was available. Patients who were lost to contact (after 7 phone calls and a mailed letter) for whom follow-up data was not available, were excluded from analysis.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlAdherence9 Participants
Motivational InterviewingAdherence17 Participants
p-value: 0.015t-test, 2 sided
Secondary

Change in Number of Monthly Emergency Department Visits

Change from baseline number of Emergency Department visits per month.

Time frame: 4 months

Population: Participants who provided this data at 4 month telephone follow-up.

ArmMeasureValue (MEAN)Dispersion
ControlChange in Number of Monthly Emergency Department Visits0.06 ED visits per monthStandard Deviation 0.47
Motivational InterviewingChange in Number of Monthly Emergency Department Visits-0.15 ED visits per monthStandard Deviation 0.76
p-value: 0.23t-test, 2 sided
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.

Time frame: 4 months

Population: Participants who provided QOLIE-10 information at 4-month follow-up

ArmMeasureValue (MEAN)Dispersion
ControlChange in Quality of Life1.8 units on QOLIE-10 scaleStandard Deviation 7.9
Motivational InterviewingChange in Quality of Life7.2 units on QOLIE-10 scaleStandard Deviation 10
p-value: 0.047t-test, 2 sided
Secondary

Percent Decrease in PNES Frequency

Percent decrease in monthly PNES frequency

Time frame: 4 months

Population: Analysis population includes all participants for whom follow-up data was available. Patients who were lost to contact (after 7 phone calls and a mailed letter) for whom follow-up data was not available, were excluded from analysis.

ArmMeasureValue (MEAN)Dispersion
ControlPercent Decrease in PNES Frequency34.8 percentage of baseline seizuresStandard Deviation 89.7
Motivational InterviewingPercent Decrease in PNES Frequency76.2 percentage of baseline seizuresStandard Deviation 39.2
p-value: 0.034t-test, 2 sided
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.

Time frame: 4 months

Population: Participants who provided information at 4 month telephone follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlPNES Freedom3 Participants
Motivational InterviewingPNES Freedom8 Participants
p-value: 0.095Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026