Rehabilitation of cognition and psychosocial well‐being in epilepsy: Results of a randomized waiting list‐controlled trial

Abstract

Objective

Limited evidence supports the use of cognitive and psychosocial rehabilitation programs for people with epilepsy (PWE). We assessed the effects of a newly designed cognitive and psychological counseling intervention on patient‐reported and neuropsychological outcomes in a mixed sample of PWE.

Methods

Seventy adult PWE (57.1% female, mean age = 35.9 ± 11.7 years, 57.1% with focal epilepsy) were randomized (1:1) to either an early intervention group (EIG) or a waiting list for a late intervention group (LIG). The intervention consisted of six individual and two group counseling sessions incorporating psychoeducation, cognitive training, coping strategies, and mindfulness. Both groups were assessed at baseline and 4 and 16 weeks. Primary endpoints were quality of life (Patient‐Weighted Quality of Life in Epilepsy 31‐item inventory [QOLIE‐31‐P]) and delayed verbal and visual recall at 4 weeks; secondary endpoints included symptoms of anxiety (Generalized Anxiety Disorder seven‐item scale), depression (Neurological Disorders Depression Inventory in Epilepsy), and stigma. Linear mixed models with maximum likelihood estimation were used for repeated measures analysis.

Results

Follow‐up data were available for 66 participants (94.3%) at 4 weeks and 61 (87.1%) at 16 weeks. The EIG showed significant improvements on the QOLIE compared with the LIG (group by time interaction p = .006), which were maintained at both follow‐ups. Anxiety symptoms were also significantly reduced in the EIG (group by time interaction p = .006). These effects were observed in both focal and generalized epilepsy. No significant group differences were found for delayed verbal or visual recall over time. However, greater long‐term forgetting on the word list task was observed in the LIG at 4 weeks. No significant changes were detected for symptoms of depression or perceived stigma.

Significance

An 8‐week cognitive and psychosocial rehabilitation program improved quality of life and reduced anxiety in PWE, with effects sustained for up to 16 weeks. Cognitive benefits were limited, with a possible transient effect on long‐term verbal recall. These findings support the use of rehabilitation interventions to enhance patient‐reported outcomes across epilepsy subtypes.

Key points.

• This randomized trial evaluated a novel 8‐week cognitive and psychosocial rehabilitation program for adults with epilepsy.

• The intervention significantly improved quality of life and reduced symptoms of anxiety up to 16 weeks postintervention.

• No major statistically significant effects were observed on neuropsychological outcomes.

1. INTRODUCTION

Epilepsy is defined by recurrent seizures, but its conceptual framework also recognizes cognitive, psychological, and social consequences as integral components of the disorder. ¹ Cognitive dysfunction, comorbid depression and anxiety, and social stigma contribute substantially to disease burden and often limit personal, educational, and professional opportunities for people with epilepsy (PWE). Addressing epilepsy‐associated life consequences, including barriers to higher education, employment, and long‐term interpersonal relationships, is recognized as a priority by the World Health Organization. ² , ³ Accordingly, patient‐oriented outcomes, including quality of life and psychiatric comorbidity, are now also included in the International Standard Set of Outcomes and Measurement Methods for Routine Practice for Adults With Epilepsy. ⁴

Despite the recognized importance of cognitive and psychosocial sequelae, research on nonpharmacological interventions targeting these outcomes remains limited compared with the extensive focus on seizure control through pharmacotherapy and epilepsy surgery. The lack of evidence supporting cognitive and psychosocial rehabilitation programs in epilepsy has long been acknowledged, with “reviews of the cognitive rehabilitation literature outnumbering original studies.” ⁵ This evidence gap likely contributes to the limited development and implementation of routine health care pathways for cognitive and psychosocial rehabilitation. For example, in a recent multinational survey of epilepsy specialists, only 36% of respondents reported that cognitive rehabilitation services were generally available for PWE in their country, and fewer than one third indicated the existence of national standards of practice or legislative support. ⁶

Earlier studies of cognitive rehabilitation in epilepsy have primarily focused on individuals with temporal lobe epilepsy and memory outcomes. ⁷ , ⁸ Although a recent meta‐analysis of six controlled studies including 229 participants reported a trend toward a positive overall effect of neuropsychological interventions, the findings did not reach statistical significance. ⁹ Consequently, evidence supporting cognitive rehabilitation in adults with epilepsy is largely derived from small, heterogeneous studies. Controlled trials evaluating broader interventions that integrate cognitive and patient‐reported outcomes, such as quality of life, remain particularly scarce. ¹⁰ , ¹¹ , ¹² , ¹³

We present results of a randomized controlled trial (ReCaP‐ABLE [Rehabilitation of Cognition and Psychosocial Well‐Being—A Better Life With Epilepsy]) designed to address both cognitive and psychosocial outcomes in a mixed sample of adults with epilepsy.

2. MATERIALS AND METHODS

2.1. Study design and patients

This randomized trial evaluated the efficacy of a psychological counseling intervention targeting both cognitive and psychosocial outcomes in adults with epilepsy. The study was set at the Center of Neurology of Vilnius University Hospital Santaros Klinikos (VUHSK; patient recruitment, and baseline and follow‐up evaluations) and the Counseling and Training Center of the Faculty of Philosophy of Vilnius University (psychological consultations).

Consecutive patients were evaluated for eligibility and recruited by the principal investigator (R.M.) during routine visits at the outpatient epilepsy clinic of VUHSK. Participant inclusion criteria were (1) active epilepsy (medication and/or at least one seizure in the past year), (2) ≥18 years old, (3) Lithuanian speaker, and (4) no intellectual disability. Exclusion criteria were (1) sensory or motor deficit preventing task completion, (2) epilepsy surgery planned during the project, (3) active nonparoxysmal comorbid disorder of the central nervous system (e.g., neurodegeneration, multiple sclerosis), (4) active psychiatric disorder during the past year, and (5) psychoactive substance use (except social alcohol, tobacco, and caffeine use). Eligible and consenting participants were then assigned by the principal investigator to either the early (EIG) or late (LIG) intervention group (ratio 1:1) using a minimization procedure (WinPepi Etcetera v3.26) balancing for age (<36/≥36 years), sex (male/female), epilepsy type (focal/generalized), and seizure frequency (<monthly/≥monthly). Participants in both groups were then referred for baseline neuropsychological evaluation and patient‐reported outcome assessment (Ar.J., K.P.). Individuals in the EIG then started a psychological counseling program lasting 8 weeks, whereas those in the LIG were waitlisted. Both groups underwent neuropsychological follow‐up by the same blinded assessor 4 and 16 weeks after the intervention (EIG) or onset of the period of waiting (LIG). The intervention was delivered to participants in the LIG only after baseline assessment, the waiting period, and both follow‐ups (the waiting periods between follow‐ups and before the onset of the intervention were equivalent to those in the EIG). Routine medical care was continued to all participants of the trial. Because of the noninvasive nature of the intervention, no harm or trial stopping criteria were set.

2.2. Intervention

The intervention was described in detail previously. ¹⁴ It was developed and conducted by two professional psychotherapy specialists (As.J., G.A.) specializing in mindfulness and cognitive behavioral therapy and consisted of six individual and two group (seven participants per group) counseling sessions (all lasting 60 min) conducted on a weekly basis in a nonhospital environment. The intervention was based on the Strategies‐Outsourcing‐Social support toolbox ⁵ and included psychoeducation, training of memory, attention, metacognition, and self‐regulation, as well as discussion of social aspects and homework (Box 1). Sessions comprised a presentation of the day's topic and homework review (10 min), discussion of the day's topic (20 min), skill building (20 min), and reflection, questions, and homework delivery (10 min). With training and initial supervision, the design of the rehabilitation program would allow it to be administered by clinical psychologists, psychotherapy candidates, and psychotherapy specialists. It has not yet been developed for use by nonlicensed or other professionals.

BOX 1. Outline of the intervention plan of the trial (adapted from Puteikis et al., ¹⁴ CC BY 4.0).

Intervention plan (8 weeks) Individual session 1 Familiarization. Goal setting. Discussion of the plan. Presentation of the mind–emotion–body connection. Homework. 2 Individual session 2 Discussion of homework. Thought exercises. Thinking training. Visual memory. Homework. 3 Individual session 3 Discussion of homework. Body senses. Attention training. Physiology training. Homework. 4 Individual session 4 Discussion of homework. Working with emotions. Influence of emotions on quality of life and memory. Emotion regulation. Memory training. Homework. 5 Individual session 5 Discussion of homework. Attention management. Metacognition training. Self‐regulation. Homework. 6 Individual session 6 Discussion of homework. Positive psychology. Strengths and resources. Memory training. Homework. 7 Group session 1 Discussion of homework. Importance of social support. Creating a circle of support. Attention training. Homework. 8 Group session 2 Discussion of homework. Compassion for self and others. Memory and quality of life. Homework. Summing up. General plan of a 60‐min session: 10 min: presentation of the topic and discussion of homework. 20 min: teaching of the topic. 20 min: skill building. 10 min: reflection. Questions. Homework.

2.3. Endpoints

At baseline and follow‐ups, participants were tested using a neuropsychological battery tapping into domains of attention, working memory, and verbal fluency, as well as verbal and visual memory (Table 1). Different versions of each memory task were used at each timepoint to minimize learning effects.

TABLE 1.

Neuropsychological battery used in the trial.

Title	Abbreviation	Domains assessed	Variables	References
Trail‐Making Task part A	TMT‐A	Cognitive tracking, psychomotor speed, short‐term memory, cognitive flexibility	Seconds to complete	15
Trail‐Making Task part B	TMT‐B
Maze Task	MT	Visual anticipation, planning, psychomotor speed
Digit Span Forward	DS‐F	Working memory	Points (length of longest sequence recalled)
Digit Span Backward	DS‐B
Phonemic Fluency	Ph‐F	Verbal fluency	Points (words generated in 60 s)
Categorical Fluency	Cat‐F
Autobiographical Fluency	AB‐F	Autobiographical fluency	Points (everyday events of the last month generated in 90 s)	16, 17
15‐word list memory task (equivalent of the Rey Auditory Verbal Learning Test) a	WLT	Memory (free verbal recall)	Memory decay (5th learning trial to immediate recall, immediate recall to 30 min, 30 min to 1 week, % of points [0–15] lost)	18
Verbal‐Logical Story Task a	VLS		Memory decay (immediate recall to 30 min, 30 min to 1 week, % of points [0–24] lost)	19, 20
Experimental Schedule Task a	EST		Memory decay (immediate recall to 30 min, 30 min to 1 week, % of points (0 to 20) lost)	14
Medical College of Georgia Complex Figure Test a	MCGCFT	Free visual recall	Memory decay (copy score to immediate recall, immediate recall to 30 min, 30 min to 1 week, % of points [0–36] lost)	21

^a Different versions of the memory tasks were used at each follow‐up.

Participants completed the Patient‐Weighted Quality of Life in Epilepsy 31‐item inventory (QOLIE‐31‐P), ²² , ²³ the Neurological Disorders Depression Inventory in Epilepsy (NDDI‐E), ²⁴ , ²⁵ the Generalized Anxiety Disorder seven‐item scale (GAD‐7), ²⁶ the Metacognition Questionnaire–30 (MCQ‐30), ²⁷ the Jacoby 3‐item Stigma Scale, ²⁸ the Liverpool Adverse Events Profile, ²⁹ , ³⁰ and the Short Form 36 Health Survey ³¹ and provided a subjective evaluation of cognitive functions and well‐being (ad hoc Likert scales 0–10) at baseline and both follow‐ups.

The coprimary endpoints of the study were (1) quality of life (QOLIE‐31‐P score), (2) verbal memory (Word List Test, delayed verbal [15‐word list] recall), and (3) visual memory (Medical College of Georgia Complex Figure Test, delayed complex figure recall). The primary treatment effect for each endpoint was defined as the between‐group difference at 4 weeks estimated from the linear mixed effects model. To control the familywise type I error rate across the three coprimary outcomes, Bonferroni adjustment was applied, with statistical significance defined as two‐sided p < .017. Minimal clinically important difference (MCID) in QOLIE‐31‐P scores was defined as >5.31 points. ²²

Symptoms of depression (NDDI‐E), anxiety (GAD‐7), and stigma (Jacoby 3‐item Stigma Scale) were prespecified as key secondary endpoints. Analyses of secondary outcomes, QOLIE‐31‐P subscales, and outcomes at 16 weeks were considered exploratory and were not adjusted for multiplicity.

2.4. Statistical analysis

The sample size was calculated for a between‐group interaction of a two‐way repeated measures analysis of variance (ANOVA) with f = .40, α = .05, 1 − β = .95 (two groups, three timepoints, .5 correlation between repeated measures, no adjustment for nonsphericity). The required sample size of n = 58 (G*Power 3.1.9.7) was increased by 20% to n = 70 to account for dropouts and correspond to sample size attrition in previous trials. ⁸

The Shapiro–Wilk test, Q–Q plots, and histograms were used to assess data normality. Chi‐squared and Fisher exact tests were used to compare the distribution of categorical variables. Mann–Whitney U‐test and Student t‐test were used to compare baseline data between groups. The change of each endpoint from baseline to 4‐ and 16‐week follow‐ups was assessed using a linear mixed model maximum likelihood analysis, which uses all available observations and allows inclusion of participants with incomplete follow‐up data under a missing‐at‐random assumption. No imputation of missing outcome data was performed. Time was treated as a categorical fixed effect (baseline, 4 weeks, 16 weeks), and models included fixed effects for group, time, and group by time interaction. Repeated measurements were modeled at the participant level using an unstructured covariance matrix to account for within‐subject correlation, equivalent to including a subject‐level random intercept. Baseline values were incorporated as part of the repeated outcome rather than entered as a separate covariate. In the case of a statistically significant group by time interaction, post hoc simple main effects with Bonferroni adjustment were used to compare in‐group and between‐group results at each timepoint. Cohen d was used for effect size estimates. Exploratory subgroup analyses were conducted using the same methodology based on (1) group session attendance and (2) epilepsy type. All tests were two‐tailed with p < .017 for coprimary outcomes (Bonferroni adjustment for multiple testing) and p < .05 for secondary outcomes as the threshold for statistical significance. Descriptive statistics are presented as observed mean ± SD, whereas within‐ and between‐group differences (and confidence intervals) are derived from the linear mixed effects models.

IBM SPSS v26 was used for statistical analysis.

2.5. Ethics

The study was conducted in accordance with the ethical principles of the World Medical Association Declaration of Helsinki and applicable local laws and regulations and was approved by the Vilnius Regional Biomedical Research Ethics Committee on October 10, 2023 (approval number 2023/10‐1544‐1001). Written informed consent was obtained from all participants prior to inclusion in the study.

2.6. Trial protocol and registration

The trial was registered at ClinicalTrials.gov (ID NCT05934786) on June 28, 2023, and its protocol was published before patient enrollment. ¹⁴ The CONSORT (Consolidated Standards of Reporting Trials) checklist is provided as Table S1. Changes to the initial trial protocol were as follows: (1) inclusion of patients with any focal epilepsy to ensure sufficient sample size (decided before enrollment); (2) addition of age to the minimization procedure, alongside sex, epilepsy type, and seizure control, to achieve age‐balanced groups (decided before enrollment); and (3) use of generalized linear mixed models instead of repeated‐measures ANOVA to allow robust intention‐to‐treat analysis with missing data (decided after data collection).

3. RESULTS

3.1. Participant flow and adherence

Between October 2023 and January 2025, 70 individuals (35 EIG and 35 LIG) were recruited. Follow‐up data were available for 66 (94.3%) at 4 weeks (34 [97.1%] in EIG and 32 [91.4%] in LIG) and 61 (87.1%) at 16 weeks (33 [94.3%] in EIG and 28 [80.0%] in LIG), until October 2025 (Figure 1). One individual allocated to the EIG did not receive the intervention because of personal time limitations, and one attended half (3/6) of all individual sessions. The remaining 33 (94.3%) attended all individual sessions. Twenty‐one (60.0%) participants attended both group sessions, six attended one group session, and eight attended none. Of those who missed at least one group session, 10 reported that the scheduled sessions were incompatible with personal or professional commitments, whereas four expressed reluctance to participate in a therapy group setting.

FIGURE 1.

Flow diagram of the study participants.

Trial groups were balanced across all sociodemographic and clinical characteristics (p > .05; Table 2).

TABLE 2.

Baseline characteristics of the study sample.

Characteristic	All participants, n = 70	Early intervention group, n = 35	Late intervention group, n = 35
Sex
Male	30 (42.9%)	15 (42.9%)	15 (42.9%)
Female	40 (57.1%)	20 (57.1%)	20 (57.1%)
Age, years	35.9 ± 11.7	37.3 ± 12.1	34.5 ± 11.4
Education
Upper secondary [ISCED 3]	20 (28.6%)	11 (31.4%)	9 (25.7%)
Postsecondary nontertiary [ISCED 4]	16 (22.9%)	5 (14.3%)	11 (31.4%)
Short cycle tertiary [ISCED 5]	1 (1.4%)	1 (2.9%)	0 (0%)
Bachelor's or equivalent [ISCED 6]	21 (30.0%)	9 (25.7%)	12 (34.3%)
Master's or equivalent [ISCED 7]	11 (15.7%)	8 (22.9%)	3 (8.6%)
Doctoral or equivalent [ISCED 8]	1 (1.4%)	1 (2.9%)	0 (0%)
Employment
Unemployed	15 (21.4%)	10 (28.6%)	5 (14.3%)
Employed part‐time	7 (10.0%)	3 (8.6%)	4 (11.4%)
Employed full‐time	38 (54.3%)	16 (45.7%)	22 (62.9%)
Student	10 (14.3%)	6 (17.1%)	4 (11.4%)
Relationship status
Not married	26 (37.1%)	11 (31.4%)	15 (42.9%)
Married	31 (44.3%)	15 (42.9%)	16 (45.7%)
Lives with partner	11 (15.7%)	7 (20.0%)	4 (11.4%)
Divorced	2 (2.9%)	2 (5.7%)	0 (0%)
Handedness
Right	63 (90.0%)	31 (88.6%)	32 (91.4%)
Left	5 (7.1%)	2 (5.7%)	3 (8.6%)
Ambidextrous	2 (2.9%)	2 (5.7%)	0 (.0%)
Epilepsy type
Generalized	30 (42.9%)	15 (42.9%)	15 (42.9%)
Focal	40 (57.1%)	20 (57.1%)	20 (57.1%)
Focal epilepsy localization
Temporal	24 (34.3%)	13 (37.1%)	11 (31.4%)
Extratemporal	16 (22.9%)	7 (20.0%)	9 (25.7%)
Focal epilepsy lateralization
Left	21 (30.0%)	12 (34.3%)	9 (25.7%)
Right	16 (22.9%)	7 (20.0%)	9 (25.7%)
Bilateral	3 (4.3%)	1 (2.9%)	2 (5.7%)
Epilepsy duration, years	18.6 ± 11.4	18.3 ± 12.7	19.0 ± 10.1
Epilepsy onset, years of age	17.3 ± 11.3	19.0 ± 11.6	15.7 ± 10.9
Seizure frequency
Less than yearly or seizure‐free	20 (28.6%)	9 (25.7%)	11 (31.4%)
Less than every 3 months	14 (20.0%)	6 (17.1%)	8 (22.9%)
Less than monthly	8 (11.4%)	5 (14.3%)	3 (8.6%)
1–3 per month	9 (12.9)	5 (14.3%)	4 (11.4%)
Four per month [once per week]	3 (4.3%)	2 (5.7%)	1 (2.9%)
Several per week or daily	16 (22.9%)	8 (22.9%)	8 (22.9%)
Antiseizure medication count
1	24 (34.3%)	12 (34.3%)	12 (34.3%)
2	27 (38.6%)	12 (34.3%)	15 (42.9%)
3	14 (20.0%)	8 (22.9%)	6 (17.1%)
4	4 (5.7%)	3 (8.6%)	1 (2.9%)
5	1 (1.4%)	0 (0%)	1 (2.9%)

Abbreviation: ISCED, International Standard Classification of Education ³² .

3.2. Primary endpoints

Baseline and follow‐up scores of all endpoints are presented in Table S2. No statistically significant baseline differences were observed between groups, except for Autobiographical Fluency, where the EIG scored lower (Z = −2.055, p = .04).

In the EIG, total QOLIE‐31‐P scores increased from 62.6 ± 14.5 (baseline) to 72.1 ± 17.3 (4 weeks) and 74.2 ± 14.1 (16 weeks). In the LIG, scores were 66.3 ± 18.9, 67.1 ± 18.3, and 70.0 ± 15.8, respectively. Linear mixed model analysis revealed a group effect of F _{1, 70.0} = .081, p = .777, a time effect of F _{2, 63.5} = 18.485, p < .001, and a group by time interaction of F _{2, 63.5} = 5.603, p = .006. Compared with the LIG, the EIG demonstrated greater but not statistically significant improvement in QOLIE‐31‐P scores at 4 weeks (between‐group difference = 4.39 points, 95% confidence interval [CI] = −4.04 to 12.83, d = .26, p = .27) and at 16 weeks (3.21 points, 95% CI = −3.88 to 10.31, d = .19, p = .37). Post hoc simple main effects analysis indicated a statistically significant improvement in the EIG from baseline to 4 weeks (within‐group difference = 10.56 points, 95% CI = 5.40–15.72, d = .73, p < .001) and baseline to 16 weeks (12.42 points, 95% CI = 7.35–17.50, d = .86, p < .001; Figure 2A). MCID in QOLIE‐31‐P scores was noted in 20 (57.1%) individuals in the EIG at 4 weeks, in comparison to eight (22.9%) in the LIG (χ ² = 11.84, p = .001). At 16 weeks, MCID was present in 19 (54.3%) and nine (25.7%) participants in the EIG and LIG, respectively (χ ² = 7.42, p = .006).

FIGURE 2.

Longitudinal changes in outcomes showing significant group by time interaction (linear mixed model analysis). Means and 95% confidence intervals (error bars) and results of post hoc simple main effects analyses (horizontal bars and asterisks) are presented. EIG, early intervention group; GAD‐7, Generalized Anxiety Disorder seven‐item scale; LIG, late intervention group; MCQ‐30, Metacognition Questionnaire–30; QOLIE‐31‐P, Patient‐Weighted Quality of Life in Epilepsy 31‐item inventory.

The subscales Social Function and Emotional Well‐Being showed similar patterns as the QOLIE‐31‐P total score. For Social Function, EIG scores increased from 74.7 ± 23.5 to 85.9 ± 21.5 (4 weeks) and 87.6 ± 15.6 (16 weeks; group effect F _{1, 70.3} = .158, p = .692; time effect F _{2, 65.8} = 7.100, p = .002; group by time interaction F _{2, 65.8} = 3.416, p = .039; post hoc, EIG baseline < EIG 4 weeks: 11.10 points, 95% CI = 2.37–19.82, d = .47, p = .008; EIG baseline < EIG 16 weeks: 13.08 points, 95% CI = 4.49–21.68, d = .56, p = .001; Figure 2B). Emotional Well‐Being scores in the EIG rose from 61.9 ± 20.1 to 74.0 ± 18.3 and 76.6 ± 16.4 (group effect F _{1, 69.6} = .398, p = .530; time effect F _{2, 64.0} = 9.370, p < .001; group by time interaction F _{2, 64.0} = 4.622, p = .013; post hoc, EIG baseline < EIG 4 weeks: 13.15 points, 95% CI = 5.47–20.84, d = .65, p < .001; EIG baseline < EIG 16 weeks: 15.55 points, 95% CI = 7.69–23.40, d = .77, p < .001; Figure 2C).

No significant group by time interaction was observed for 30‐min delayed word list recall. The prespecified between‐group contrast at 4 weeks showed a difference of 10.09% (95% CI = .98–19.20, d = .41, p = .03), which did not meet the Bonferroni‐adjusted significance threshold (p < .017). The difference at 16 weeks was 8.63% (95% CI = −1.73 to 19.00, d = .39, p = .101). Word list forgetting over 1 week was higher in the LIG at 4 weeks (p = .014), returning to parity with the EIG again at 16 weeks (group effect F _{1, 51.1} = .242, p = .625; time effect F _{2, 43.0} = 6.181, p = .004; group by time interaction F _{2, 43.0} = 3.650, p = .034; Figure 2D). No statistically significant group by time interaction was found for visual recall (between‐group difference = .47%, 95% CI = −3.77 to 4.70, d = .005, p = .83 at 4 weeks and 1.64%, 95% CI = −5.01 to 8.29, d = .17, p = .62 at 16 weeks).

3.3. Secondary endpoints

Symptoms of anxiety (GAD‐7) decreased in the EIG from 7.2 ± 4.3 (baseline) to 4.6 ± 3.8 (4 weeks) and 4.5 ± 3.7 (16 weeks; group effect F _{1, 70.9} = 1.447, p = .233; time effect F _{2, 59.7} = 3.445, p = .038; group by time interaction F _{2, 59.7} = 5.676, p = .006). Compared with the LIG, the EIG demonstrated greater improvement in GAD‐7 scores at 4 weeks (between‐group difference = 2.42 points, 95% CI = .22–4.61, d = .57, p = .031) and a non‐statistically significant improvement at 16 weeks (1.75 points, 95% CI = −.09 to 3.60, d = .41, p = .062). Post hoc comparisons indicated statistically significant within‐group reductions in the EIG at both follow‐ups compared with baseline (2.87 points, 95% CI = .97–4.77, d = .67, p = .001 at 4 weeks and 2.88 points, 95% CI = .97–4.80, d = .67, p = .001 at 16 weeks; Figure 2E).

The MCQ‐30 subscale Negative Beliefs About Worry score decreased at 4 weeks in the EIG compared to baseline (p = .029; group effect F _{1, 69.0} = .060, p = .807; time effect F _{2, 64.0} = 2.004, p = .143; group by time interaction F _{2, 64.0} = 3.389, p = .040; Figure 2F).

No other neuropsychological or patient‐reported outcomes showed statistically significant group by time interactions.

3.4. Subgroup analysis

Subgroup analysis demonstrated QOLIE‐31‐P score improvements among EIG participants who attended none or both sessions (at 4 and 16 weeks; Table S3). Symptoms of anxiety diminished at 4 and 16 weeks among participants of the EIG who attended both sessions.

Both focal and generalized epilepsy subgroups of the EIG had improved QOLIE‐31‐P and GAD‐7 scores at follow‐up (Table S3).

4. DISCUSSION

We conducted a randomized controlled trial examining the effects of an 8‐week cognitive and psychosocial rehabilitation program on adults with epilepsy. The program significantly improved quality of life in the intervention group at 4 weeks, with effects maintained at 16 weeks. Despite higher baseline QOLIE‐31 scores compared with previous trials, the observed improvements were similar in magnitude to those reported in the HOBSCOTCH (Home‐Based Self‐Management and Cognitive Training Changes Lives) trials, which showed 9.1–12.4‐point increases up to 3 months postintervention. ¹⁰ , ¹¹ The mean improvement in QOLIE‐31 exceeded the MCID and approached the threshold for a large clinically meaningful change, as defined by Borghs et al., with more than 50% participants in the EIG achieving MCID at 4 and 16 weeks. ²² The improvement in quality of life is largely attributed to the positive trends on the Emotional Well‐Being and Social Function subscales, consistent with the program's emphasis on introspection, mindfulness, self‐control, emotion regulation, and metacognition (individual sessions) as well as compassion and social support (group sessions). A decrease in the MCQ‐30 Negative Beliefs About Worry subscale in the EIG at 4 weeks suggests that metacognitive components of the intervention may have contributed to reductions in anxiety. This subscale of the MCQ‐30 reflects metacognitive beliefs that worrying is uncontrollable and dangerous, thus creating a vicious cycle of “worry about worry.” ²⁷ Such beliefs have been shown to be associated with symptoms of both anxiety and depression among PWE, making metacognitive training a potential candidate to address the genesis of psychological symptomatology. ³³ Exploratory subgroup analyses indicated that participants attending both group sessions experienced the greatest decrease in anxiety, suggesting a possible role of social interaction. However, the overall reduction in symptoms of anxiety did not constitute a clinically meaningful improvement (with the threshold set at a reduction by 3–4 points), ³⁴ , ³⁵ likely owing to low baseline GAD‐7 scores. Accordingly, no significant changes in depressive symptoms were observed, in line with previous studies. ¹⁰ , ¹¹ , ¹³

Cognitive outcomes showed limited improvement. The only effect was a possible stabilization of long‐term (1 week) verbal memory in the EIG, whereas the LIG demonstrated increased forgetting at the 4‐week follow‐up. To the best of our knowledge, no group studies have assessed the rehabilitation of long‐term forgetting. ⁸ The mechanism underlying LIG memory decline is unknown, although the influence of verbal information learned during the baseline examination may have contributed to subsequent decline in long‐term recall through proactive interference. ³⁶ However, this finding should be interpreted cautiously because of limited data available for long‐term recall analysis. The lack of broader cognitive gains likely reflects the program's focus on compensatory strategies, psychoeducation, and general cognitive techniques, with limited time devoted to targeted cognitive restitution. Recent evidence suggests that targeted techniques may have long‐term positive effects on memory function, but do not transfer to other domains or have effects on mood and quality of life. ¹³ Evidence of far‐transfer effects from earlier studies is also limited to subjective patient perceptions, ⁸ whereas near‐transfer effects have been demonstrated in children with epilepsy. ³⁷ Therefore, the benefit of compensatory and mixed cognitive rehabilitation techniques remains to be demonstrated in real‐world settings.

The strengths and limitations of the current study should be acknowledged. The sample was largely representative of the general epilepsy population consulted at the clinic, differing in educational level, type of epilepsy, antiseizure medication count, and seizure frequency, with an average epilepsy duration of almost 2 decades. However, the sample size of the study remained relatively small, limiting the detection of subtle changes across the outcomes assessed and preventing robust subgroup analyses, the latter being underpowered in the current trial. The intervention was short, although it aimed to incorporate aspects of education, psychological support, and cognitive rehabilitation. It was feasible with relatively low participant attrition during individual sessions. Group sessions, however, were less well attended, which likely led to a reduced benefit. Difficulties in finding a convenient time for group sessions, as well as hesitations regarding the group format, were predominant reasons for missing appointments. Concerns related to epilepsy‐associated stigma may also contribute to reluctance to participate in group settings. Such barriers have been described previously ³⁸ , ³⁹ and may be mitigated by scheduling group sessions earlier and by emphasizing their role as an integral component of the therapeutic process. Finally, although the first follow‐up at 4 weeks allowed some consolidation of therapeutic gains, ⁴⁰ the immediate postintervention effects remain unknown. On the other hand, the follow‐up period was longer than in most earlier reports. ⁸

5. CONCLUSIONS

The current trial demonstrates that a newly designed 8‐week‐long program of cognitive and psychological rehabilitation improves quality of life and reduces symptoms of anxiety in a mixed sample of adult PWE for up to 16 weeks postintervention. The impact of the intervention on neuropsychological endpoints remained limited, with a possible transient stabilizing effect of long‐term verbal memory function. Future studies should explore the real‐world applicability of such interventions, their long‐term impact on mental health, and broader socioeconomic outcomes.

AUTHOR CONTRIBUTIONS

Conceptualization: Kristijonas Puteikis, Arminas Jasionis, Asta Jakonienė, Gintarė Aukselė, Peter Wolf, and Rūta Mameniškienė. Data curation: Kristijonas Puteikis. Formal analysis: Kristijonas Puteikis. Funding acquisition: Rūta Mameniškienė. Investigation: Kristijonas Puteikis and Rūta Mameniškienė. Methodology: Kristijonas Puteikis, Arminas Jasionis, Asta Jakonienė, Peter Wolf, and Rūta Mameniškienė. Project administration: Rūta Mameniškienė. Resources: Kristijonas Puteikis and Rūta Mameniškienė. Software: Kristijonas Puteikis. Supervision: Rūta Mameniškienė. Validation: Rūta Mameniškienė. Visualization: Kristijonas Puteikis. Writing—Original Draft Preparation: Kristijonas Puteikis, Arminas Jasionis, Asta Jakonienė, Gintarė Aukselė, Peter Wolf, and Rūta Mameniškienė. Writing—Review & Editing: Kristijonas Puteikis, Arminas Jasionis, Asta Jakonienė, Gintarė Aukselė, Peter Wolf, and Rūta Mameniškienė.

FUNDING INFORMATION

This project has received funding from the Research Council of Lithuania (LMTLT, Gedimino pr. 3, LT‐01103 Vilnius, Lithuania, phone +370 670 32435, e‐mail: info@lmt.lt), agreement No P‐MIP‐23‐333. The funder had no role in study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication, or ultimate authority over any of these activities.

CONFLICT OF INTEREST STATEMENT

None of the authors has any conflict of interest to disclose. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.

Supporting information

Table S1.

Puteikis K, Aukselė G, Jakonienė A, Jasionis A, Wolf P, Mameniškienė R. Rehabilitation of cognition and psychosocial well‐being in epilepsy: Results of a randomized waiting list‐controlled trial. Epilepsia. 2026;67:3674–3685. 10.1002/epi.70248

DATA AVAILABILITY STATEMENT

The data that support the findings of this study are available from the corresponding author upon reasonable request accompanied by a data analysis plan.