Motivational Interviewing to Enhance Adherence of Patients With Psychogenic Non-epileptic Seizures: A Model of Patient Engagement in Functional Neurological Symptom Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: standard psychotherapy (Behavioral)
MI
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).
干预措施: motivational interviewing (Behavioral)
MI
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).
干预措施: standard psychotherapy (Behavioral)
结局指标
主要结局
Adherence
时间窗: 4 months
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.
次要结局
- 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)
研究者
Benjamin Tolchin
Clinical Fellow
Brigham and Women's Hospital