Clinical trial NCT06537986: A Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy
Official title: Testing the Efficacy of a Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug Resistant Epilepsy
Keywords: Epilepsy,
Neurocognitive
Psychosocial
module
Lead sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with epilepsy, especially drug-resistant epilepsy, have a lot of cognitive \& psycho-social issues. There is little evidence pertaining to the efficacy of the various cognitive-behavioral interventions and cognitive retraining modules used in epilepsy patients in the Indian context. The real value of these interventions needs further consolidation in terms of its assessment and efficacy. The available literature is scanned and having limitations in terms of assessment tool used, sample size, and also lacks a broader spectrum of psychosocial interventions used. In view of the above limitations, we plan to specially develop \& test a Neuro-cognitive and psychosocial intervention module, based on the deficits found in these domains that will help DRE patients to improve their quality of life. This module will be covering not only the broader spectrum of assessment tools but also varieties of interventions. This module will help in planning the future needs of epileptic patients in terms of not only medication but also guide us in choosing the kind of interventions to be used with a particular patient or group of patients.

Detailed description: We plan to specially develop \& test a Neuro-cognitive and psychosocial intervention module, based on the deficits found in these domains that will help DRE patients to improve their quality of life. This module will be covering not only the broader spectrum of assessment tools but also varieties of interventions.

AIM To develop and test the efficacy of Neuro-cognitive and psychosocial intervention module in drug-resistant epilepsy.

Clinical Sample: The sample will consist of patients with Drug-resistant epilepsy (DRE). Patients with Drug-resistant epilepsy (DRE) will be included per inclusion and exclusion criteria. The subjects will be taken from the patients attending Refractory epilepsy clinic (REC), Department of Neurology, PGIMER, Chandigarh.

Informed written consent will be obtained from all the study participants per the rules and regulations of the Institutional Ethics Committee of PGIMER.

Study design: It will be a pre and post-design. Subjects fulfilling the inclusion and exclusion criteria will be randomly assigned to intervention and control groups-a Hospital-based Randomized Control Trial Study.

Sample Size: n=60 Follow-up Schedule - Both Pre and post-neuropsychological and psychosocial assessments will be done for all patients.

1. Intervention group - will have an intervention module between pre and post-assessment.
2. Control group - only follow up between Pre and post-assessment. All the randomized patients will be followed up for outcome assessment at 3 to 6 months of the recruitment (Depending on the module).

Statistical Justification:

1. Descriptive statistics will be used in terms of frequency, percentages, range, means, and standard deviations.
2. Group differences between intervention and control groups will be carried out using a t-test.
3. Correlations will be carried out among all the clinical and neuropsychological variables.
4. Linear stepwise regression analysis will be carried out for clinical, neuropsychological, and psychosocial variables separately.
5. Other appropriate statistics would be used as per the requirements of the study.

Eligibility criteria: Inclusion Criteria:

1. Participants of 18 - 45 years of age.
2. either gender
3. Willing to participate and sign the informed consent

Exclusion Criteria:

1. Patients with other neurological disorders
2. any other trial at inclusion
3. should not have any major psychiatric disorder
4. pregnant and lactating mothers
5. also, patients who would not be giving informed consent
6. Patients with intellectual disabilities.

Primary outcomes:
measure: Evaluation of improvement in quality of life after receiving an intervention module.
timeFrame: 2 -3 years
Secondary outcomes:
measure: Evaluation of depression in drug-resistant epilepsy patients after receiving an intervention module.
timeFrame: 2 -3 years
measure: Evaluation of anxiety in drug-resistant epilepsy patients after receiving an intervention module.
timeFrame: 2 -3 years
measure: Evaluation of stigma in drug-resistant epilepsy patients after receiving an intervention module.
timeFrame: 2 -3 years
measure: Evaluation of Disability in drug-resistant epilepsy patients after receiving an intervention module.
timeFrame: 2 -3 years
measure: Evaluation of improvement in attention among patients with drug-resistant epilepsy after receiving an intervention module.
timeFrame: 2 -3 years
measure: Evaluation of improvement in memory among patients with drug-resistant epilepsy after receiving an intervention module.
timeFrame: 2 -3 years
measure: Evaluation of improvement in executive functioning among patients with drug-resistant epilepsy after receiving an intervention module.
timeFrame: 2 -3 years
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate institute of medical education and research , Chandigarh
Study officials:
affiliation: PGIMER, Chandigarh
name: Dr. Parampreet Singh Kharbanda, MD, DM
role: STUDY_CHAIR
References: