A study to evaluate a brief internet-based intervention for patients with newly diagnosed functional seizures.
Content or context? A three-parallel arm randomised controlled trial to evaluate a brief internet-based intervention on seizure frequency for patients with newly diagnosed functional seizures.
Alfred Health
111 participants
Mar 21, 2022
Interventional
Conditions
Summary
The objective of this study is to investigate the effect of an internet-based self-help intervention program on seizure frequency for individuals with functional seizures. The first aim of this project is to develop an internet-based therapy for patients with functional seizures. To assess this new therapy, patients with a documented diagnosis of functional seizures will undertake a 5-week e-intervention, called re-PROGRAM, either guided by a therapist or on their own, followed by standard care. A third group of participants will receive standard care, which involves an appointment with a psychiatrist every 6 weeks. A goal of the research is to find out whether undertaking re-PROGRAM is more effective than standard care, and whether undertaking re-PROGRAM while guided by a therapist provides any further benefit to patients than engaging with the program with limited therapist contact. The second aim of this project is to assess the cognitive function and behavioural characteristics in patients with functional seizures and to identify predictors for successful treatment outcomes. Establishing why some people respond to treatment better than others will assist in developing more tailored therapy approaches and provide a better understanding of patients’ therapy experiences.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Re-PROGRAM is a 5-week structured skills-based program designed to enhance participants’ knowledge of functional seizures and expose them to seizure-controlling strategies. It is designed to be delivered with or without assistance from a therapist and is based on a framework of cognitive behavioural therapy (CBT). It has been designed specifically for this study. Arm 1: re-PROGRAM synchronous therapy arm. A psychologist will interact with the participant via videoconferencing in a weekly individual one-hour session across five consecutive weeks. The psychologist with minimum 2 years’ experience will use a standardised therapy manual, specifically designed for this study, conceptualised and piloted for safety, feasibility, and acceptability. Following intervention completion, participants will attend a half hour appointment with a psychiatrist with minimum 3 years’ experience in the functional seizures clinic approximately every six weeks until 12 months post baseline. Arm 2: Unguided re-PROGRAM arm. Access to the internet intervention across five consecutive weeks. Asynchronous psychologist support will take part individually. Participants will be provided with a recommended timetable of weekly module completion and instructions detailing how to contact a psychologist with minimum 2 years’ experience within the platform regarding technical difficulties. They will receive 10 mins per week of psychologist-client contact in the form of email correspondence. In general, the role of the psychologist in this arm is to ensure participants progress through the e-intervention and complete activities and homework on time. The psychologist will be permitted to give feedback on homework, answer questions (providing reference to the program when necessary), encourage progress, provide support and validation, and handle scheduling issues. The psychologist will answer questions within 24 hrs. Following intervention completion, participants will attend a half hour appointment with a psychiatrist with minimum 3 years’ experience in the functional seizures clinic approximately every six weeks until 12 months post baseline. In Arm 1 and Arm 2 for the subsequent appointments with psychiatry, medical care will be identical to the control group i.e., will include support, consideration of psychiatric comorbidities and any associated drug treatment and general review of participant health, but CBT techniques or reinforcement of the strategies and tools learnt during the intervention will not be discussed. Subsequent treatment will be delivered as per our usual clinical practice, i.e., in person if conditions permit and if patient is able, otherwise, via Telehealth. Adherence to the internet self-guided intervention will be monitored through online website data logs and weekly email confirmation. Attendance records will be kept to monitor adherence to the therapist-guided intervention.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12622000262707