Clinical trial NCT05934786: Rehabilitation of Cognition and Psychosocial Well-being in Epilepsy
Official title: Rehabilitation of Cognition and Psychosocial Well-being - A Better Life With Epilepsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
neuropsychology
memory
cognitive functions
quality of life
mental health
rehabilitation
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

The sample size was calculated for a between-group interaction of a two-way repeated measures analysis of variance (ANOVA) with f=0.40, α=0.05, β=0.95, two groups (early and late intervention), three measurement points, 0.5 correlation between repeated measures and no adjustment for non-sphericity. The resulting sample size of n=58 (G\*Power 3.1.9.7) was increased by 20% to n=70 to account for dropouts and corresponded well to the mean sample size and attrition rates in previous trials (Joplin et al., 2018).

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)

Components of the baseline evaluation:

Demographic and socioeconomic characteristics (case report form) Clinical characteristics (e.g., seizure frequency, type and duration of epilepsy, medication use, comorbidities, previous exposure to psychological counseling), case report form.

Epilepsy re-evaluation by the neurologist (including electroencephalography) Questionnaire data (scales used): quality of life (QOLIE-31-P), anxiety (GAD-7), depression (NDDI-E), suicidality (Columbia Suicide Severity Rating Scale), metacognition (MCQ-30), Jacoby's 3-item Stigma Scale, antiseizure drug adverse effects (LAEP), the Short Form (36) Health Survey, subjective evaluation of cognitive functions (ad hoc Likert scales 0 to 10).

Objective neuropsychological assessment, up to one hour per examination (indicated examples may be substituted by equivalent tests):

Reaction speed (e.g., Trail Making Tests A and B) Working memory (e.g., Digit Span Test) Verbal fluency (e.g., categorical, phonemic naming) Short-term and long-term memory: verbal (short story or word list) and visuospatial (complex figure) at three delays (e.g., immediate, 30 min, and 4 weeks) to test for accelerated forgetting.

Experimental memory tasks with high everyday significance (e.g., map learning, appointment memory, close autobiographical memory) Task 2.2. The intervention (2024-03-01 to 2024-11-31 (early intervention group) and 2025-06-01 to 2026-03-31 (late intervention group)) Patient randomization will be done using dedicated software (e.g., https://www.randomizer.org/). The investigators performing questionnaire-based and neuropsychological assessment will be blinded from the status of the patient.

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 per patient). The intervention will consist of all parts of the Strategies-Outsourcing-Social support toolbox (Baxendale, 2020) and include psychoeducation, lifestyle issues, coping strategies and homework. It will be developed after group meetings and all psychologists will be trained by a leading specialist to ensure standardization.

Task 2.3. End of patient recruitment and intervention, last follow-up investigations (2024-12-01 to 2025-03-31, 4 months) Objective 3: To conduct data analysis and disseminate the results (2025-04-01 to 2026-03-31, 12 months) Task 3.1 Data analysis, drafting, and editing of the final report, publication, and presentation of the study results (2025-04-01 to 2026-03-31, 12 months).

The efficacy of the intervention will be defined as a significant improvement in one of the primary outcomes (quality of life or verbal memory), tested with a repeated measure between factors AN(C)OVA. Dynamic changes of other outcome measures will be tested respectively. The association between demographic and clinical variables with study endpoints will be conducted by means of linear and ordinal regression modeling. Open-access publishing of the study results will be sought.

Intervention is simultaneously done for the late intervention group, which is treated as a waitlist control during data analysis (see Task 2.2).

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of life index
timeFrame: Immediately before intervention and after.
measure: Delayed verbal recall
timeFrame: Immediately before intervention, after 30 minutes and after 4 weeks immediately after intervention
measure: Delayed visual recall
timeFrame: Immediately before intervention, at 30 minutes and immediately after intervention at 4 weeks
Secondary outcomes:
measure: Mood
timeFrame: Immediately before and two times (immediately after the intervention and 8 weeks later).
measure: Anxiety
timeFrame: Immediately before and after intervention.
measure: Stigma
timeFrame: Immediately before and after intervention.
Other outcomes:
Locations:
Study officials:
References: