Rehabilitation of Cognition and Psychosocial Well-being in Epilepsy

NCT05934786 | Active Not Recruiting

• 1 other identifier: ReCaP-ABLE-1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Epilepsy; neuropsychology; memory; cognitive functions; quality of life; mental health; rehabilitation

Outcome Measures

Primary Outcomes (3)

• Quality of life index

  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

  Immediately before intervention and after.

• Delayed verbal recall

  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

  Immediately before intervention, after 30 minutes and after 4 weeks immediately after intervention

• Delayed visual recall

  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.

  Immediately before intervention, at 30 minutes and immediately after intervention at 4 weeks

Secondary Outcomes (3)

• Mood

  Immediately before and two times (immediately after the intervention and 8 weeks later).

• Anxiety

  Immediately before and after intervention.

• Stigma

  Immediately before and after intervention.

Study Arms (2)

Early intervention group

ACTIVE COMPARATOR

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).

Behavioral: Cognitive rehabilitation

late intervention group

ACTIVE COMPARATOR

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).

Behavioral: Cognitive rehabilitation

Interventions

Cognitive rehabilitation BEHAVIORAL

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.

Early intervention group; late intervention group

Eligibility Criteria

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

You may qualify if:

• Active epilepsy (medication for epilepsy and/or had at least one seizure in the past year)
• Adults (\>17 years)
• Lithuanian speaker
• No intellectual disability

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Location

Related Publications (1)

• Puteikis K, Jakoniene A, Jasionis A, Wolf P, Mameniskiene R. Rehabilitation of cognition and psychosocial well-being - a better life with epilepsy (ReCaP-ABLE): a protocol for a randomized waitlist-controlled trial. Front Neurol. 2023 Oct 27;14:1273550. doi: 10.3389/fneur.2023.1273550. eCollection 2023.

  PMID: 37965169 DERIVED

MeSH Terms

Conditions

Epilepsy; Psychological Well-Being

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, senior researcher

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 7, 2023
• Study Start: October 11, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)