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

NCT06537986 | Recruiting DMC

• 1 other identifier: 12818/PG-20/1 Trg
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Resistant Epilepsy

Keywords

Epilepsy,; Neurocognitive; Psychosocial; module

Outcome Measures

Primary Outcomes (1)

• Evaluation of improvement in quality of life after receiving an intervention module.

  Quality of life in epilepsy-31 scale was used to assess quality of life. The scores are usually transformed into a 0-100 scale, with higher scores indicating a better quality of life.

  2 -3 years

Secondary Outcomes (7)

• Evaluation of depression in drug-resistant epilepsy patients after receiving an intervention module.

  2 -3 years

• Evaluation of anxiety in drug-resistant epilepsy patients after receiving an intervention module.

  2 -3 years

• Evaluation of stigma in drug-resistant epilepsy patients after receiving an intervention module.

  2 -3 years

• Evaluation of Disability in drug-resistant epilepsy patients after receiving an intervention module.

  2 -3 years

• Evaluation of improvement in attention among patients with drug-resistant epilepsy after receiving an intervention module.

  2 -3 years

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Neurocognitive and psychosocial intervention module

Control Group

NO INTERVENTION

Standard therapy without intervention module

Interventions

Neurocognitive and psychosocial intervention module 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients with other neurological disorders
• should not have any major psychiatric disorder
• pregnant and lactating mothers
• also, patients who would not be giving informed consent
• Patients with intellectual disabilities.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate institute of medical education and research , Chandigarh

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dr. Parampreet Singh Kharbanda, MD, DM

  PGIMER, Chandigarh

  STUDY CHAIR

Central Study Contacts

Neetu Choudhary, Ph.D

CONTACT

08800136337; Neetumeel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Stat Trek software will be adopted to randomize the patients. It is a computer-generated randomization technique. Numbering of the groups has been decided based on coin-flipping. 1. Intervention group 2. Control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 5, 2024
• Study Start: February 15, 2022
• Primary Completion: January 6, 2025
• Study Completion: April 30, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)