N/A
N=60
Motivational Interviewing to Enhance Adherence of Patients With Psychogenic Non-epileptic Seizures
Psychogenic Non-epileptic Seizures, Motivational Interviewing
Bottom Line
View on ClinicalTrials.gov: NCT02598076 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Adherence — 9; 17 Participants — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- motivational interviewing (Behavioral); standard psychotherapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence |
9; 17 | 0.015 sig |
| SECONDARY Percent Decrease in PNES Frequency |
34.8; 76.2 | 0.034 sig |
| SECONDARY Change in Number of Monthly Emergency Department Visits |
0.06; -0.15 | 0.23 |
| SECONDARY PNES Freedom |
3; 8 | 0.095 |
| SECONDARY Change in Quality of Life |
1.8; 7.2 | 0.047 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02598076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.