A Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy

NCT ID: NCT06537986

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2025-04-30

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.

Conditions

Drug Resistant Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

Standard therapy with intervention module (Module comprised of Cognitive retraining exercise and cognitive behavioral therapy- pen and paper based) Duration - 8 weeks Frequency - once in a week for 2 hours. In person delivery of intervention in a group of 5 patients.

Group Type: EXPERIMENTAL

Neurocognitive and psychosocial intervention module

Intervention Type: BEHAVIORAL

The module comprised of various intervention methods that include- I. Cognitive Retraining: Pen-and-paper-based cognitive rehabilitation program that is divided into five hierarchically graded modules: Attention, Visual Processing, Memory, Information Processing, and Executive Functions.

2.Cognitive-behavioral interventions. Cognitive-behavioral interventions would be carried out for activities scheduling, problem-solving teachings, anger management techniques, modifications of negative cognitions, stigma address measures, and irrational beliefs about epilepsy, etc.

3. Marital/Family counseling: Marital/family counseling would be done to ensure family understanding of the patient's illness, his/her treatment, prognosis, and outcome. Family complications arising due to illness would also be discussed. Individual and personal needs of the husband, a wife will also be discussed.

Control Group

Standard therapy without intervention module

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Neurocognitive and psychosocial intervention module

The module comprised of various intervention methods that include- I. Cognitive Retraining: Pen-and-paper-based cognitive rehabilitation program that is divided into five hierarchically graded modules: Attention, Visual Processing, Memory, Information Processing, and Executive Functions.

2.Cognitive-behavioral interventions. Cognitive-behavioral interventions would be carried out for activities scheduling, problem-solving teachings, anger management techniques, modifications of negative cognitions, stigma address measures, and irrational beliefs about epilepsy, etc.

3. Marital/Family counseling: Marital/family counseling would be done to ensure family understanding of the patient's illness, his/her treatment, prognosis, and outcome. Family complications arising due to illness would also be discussed. Individual and personal needs of the husband, a wife will also be discussed.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Neetu Choudhary

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Parampreet Singh Kharbanda, MD, DM

Role: STUDY_CHAIR

PGIMER, Chandigarh

Locations

Post Graduate institute of medical education and research , Chandigarh

Chandigarh, , India

Site Status: RECRUITING

Countries

India

Central Contacts

Neetu Choudhary, Ph.D

Role: CONTACT

Neetumeel@gmail.com

08800136337

Facility Contacts

Dr parampreet singh kharbanda, MD,DM

Role: primary

neuroparam@hotmail.com

7087009696

Other Identifiers

12818/PG-20/1 Trg

Identifier Type: -

Identifier Source: org_study_id