Rehabilitation of Cognition and Psychosocial Well-being - A Better Life With Epilepsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Vilnius University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Quality of life index
Study Overview
Brief Summary
Epilepsy is a complex and chronic neurological disorder whose definition is not limited to seizures and also includes social, psychological, and cognitive consequences associated with this frequent condition. Despite good knowledge of the burden of cognitive deficits and psychosocial difficulties in epilepsy, there have been few attempts to address these issues through rehabilitation programs. The Rehabilitation of Cognition and Psychosocial well-being - A Better Life with Epilepsy (ReCaP-ABLE) study will consist of the creation and implementation of a psychological intervention in a randomized waitlist-controlled trial within a sample of adults with epilepsy. The trial is designed to provide novel evidence regarding 1) the effectiveness of a psychological-cognitive intervention in improving quality of life, objective and subjective cognitive functioning as well as reducing mental health symptomatology, 2) the target epilepsy population for which cognitive and psychosocial rehabilitation is most effective, and 3) the transfer effects of such an intervention. This interdisciplinary trial involving neurology and psychology specialists is set to guide evidence-based treatment for cognitive and psychological comorbidities that are prevalent in epilepsy but receive insufficient attention in clinical settings.
Detailed Description
The aim of the current project is to conduct a randomized waitlist-controlled trial of an original CoRE program, assess its overall efficacity and determine factors associated with a better response to this intervention.
Work schedule Objective 1: To prepare for the study before patient enrolment (2023-04-01 to 2023-12-31, 9 months) Task 1.1. Acquisition of ethical approval according to local regulations, preparation of infrastructure (e.g., reservation of dedicated examination rooms), and personnel. The required infrastructure for clinical examination and evaluation (e.g., electroencephalography, examination rooms) will be available within the clinical center of Vilnius University Hospital Santaros Klinikos while the infrastructure for the conduct of the intervention will be available at the Counseling and training center of the Faculty of Philosophy at Vilnius University. Vilnius University will also provide access to the data management software "MIDAS" and the statistical package for data analysis (SPSS).
Task 1.2. Development of experimental testing material and intervention. This subtask will be accomplished through meetings between investigators in clinical neurology and psychology. Experimental testing material will be developed after conducting a literature review and discussing the tests' feasibility (e.g., duration, mode of application, result analysis).
Task 1.3. Preparation of the study protocol for publication (expected acceptance before patient enrolment) Objective 2: To start patient enrolment and baseline evaluation (2024-01-01 to 2024-02-31, 2 months) and proceed with continuous enrolment, evaluation, intervention, and follow-up (2024-03-01 to 2024-11-30, 9 months).
Task 2.1. Patient recruitment and baseline evaluation Patients will be recruited by neurologists and explained the purpose and workflow of the trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Active epilepsy (medication for epilepsy and/or had at least one seizure in the past year)
- •Adults (>17 years)
- •Lithuanian speaker
- •No intellectual disability
Exclusion Criteria
- •Sensory or motor deficit preventing task completion
- •Epilepsy surgery planned during the project
- •Active non-paroxysmal comorbid disorder of the central nervous system (e.g.,
- •neurodegeneration, multiple sclerosis)
- •Active psychiatric disorder during the past year
- •Psychoactive substance use (except social alcohol, tobacco and caffeine use)
Arms & Interventions
Early intervention group
The intervention is planned to consist of six individual one-hour therapy sessions with certified psychologists followed by two group sessions (a total of two months (8 weeks) per patient).
Intervention: Cognitive rehabilitation (Behavioral)
late intervention group
For 8 weeks this group will receive the usual treatment, then, after repeated cognitive evaluation, will receive the same intervention: six individual one-hour therapy sessions with certified psychologists followed by two group sessions (a total of two months per patient).
Intervention: Cognitive rehabilitation (Behavioral)
Outcomes
Primary Outcomes
Quality of life index
Time Frame: Immediately before intervention and after.
QOLIE-31-P will be used before and after interventions. The efficacy of the intervention will be defined as a change from baseline value immediately before intervention at 8 weeks immediately after intervention
Delayed visual recall
Time Frame: Immediately before intervention, at 30 minutes and immediately after intervention at 4 weeks
The complex figure test will be used immediately before the intervention, repeated after 30 minutes and immediately after intervention after 4 weeks. The efficacy of the intervention will be defined as a change from baseline value at 30 minutes and a change from baseline value at 4 weeks.
Delayed verbal recall
Time Frame: Immediately before intervention, after 30 minutes and after 4 weeks immediately after intervention
The short story and word list will be used immediately before the intervention, repeated after 30 minutes and immediately after intervention after 4 weeks. The efficacy of the intervention will be defined as a change from baseline value at 30 minutes and a change from baseline value at 4 weeks
Secondary Outcomes
- Stigma(Immediately before and after intervention.)
- Mood(Immediately before and two times (immediately after the intervention and 8 weeks later).)
- Anxiety(Immediately before and after intervention.)
Investigators
Ruta Mameniskiene
Professor, senior researcher
Vilnius University