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

NCT02598076 | Completed Results

• 1 other identifier: 2015P001152
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychogenic Non-epileptic Seizures, Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percent Decrease in PNES Frequency

  4 months

• Change in Number of Monthly Emergency Department Visits

  4 months

• PNES Freedom

  4 months

• Change in Quality of Life

  4 months

Study Arms (2)

control

ACTIVE COMPARATOR

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.

Behavioral: standard psychotherapy

MI

EXPERIMENTAL

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 the study author who is a board certified neurologist and who has 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 Brigham and Women's Hospital or referred to a local psychotherapist according to their preference (identical treatment in control and MI arms).

Behavioral: motivational interviewing; Behavioral: standard psychotherapy

Interventions

motivational interviewing BEHAVIORAL

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.

MI

standard psychotherapy BEHAVIORAL

Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES

MI; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• American Academy of Neurology: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Benjamin Tolchin, MD, MS
• Organization: Yale Comprehensive Epilepsy Center, Department of Neurology, Yale Univseristy School of Medicine

benjamin.tolchin@yale.edu

347-721-8491

Study Officials

• Barbara Dworetzky, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 5, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 24, 2019
• Results First Posted: April 24, 2019

Record last verified: 2019-04

Locations

US (1)