Actively Recruiting
Testing the Efficacy of a Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2024-08-05
60
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to develop and test a special neuro-cognitive and psychosocial intervention module for patients with drug-resistant epilepsy (DRE) to improve their quality of life. The study addresses the lack of evidence on effective cognitive-behavioral treatments in epilepsy patients, especially in the Indian context, by covering a broad range of assessment tools and psychosocial interventions. The goal is to better plan future treatment and support for people with epilepsy beyond medication alone. Participants are randomly assigned to one of two groups: an intervention group that receives the specially designed module and a control group that receives standard therapy without the module. The intervention includes cognitive retraining exercises, cognitive-behavioral therapy, and marital/family counseling, delivered in person once a week for two hours over eight weeks. The study follows a hospital-based randomized control trial design with a total sample size of 60 patients. Participants will undergo neuropsychological and psychosocial assessments before and after the intervention. Follow-up occurs between three and six months after recruitment to measure outcomes such as quality of life, depression, anxiety, stigma, disability, attention, memory, and executive functioning. The study uses various statistical methods to analyze the data and monitor the effects of the intervention module over a period of two to three years.
CONDITIONS
Brief Title
A Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 45 years
- Any gender
- Willing to participate and sign informed consent
You will not qualify if you...
- Patients with other neurological disorders
- Currently participating in any other trial
- Major psychiatric disorders
- Pregnant or lactating women
- Unable or unwilling to give informed consent
- Patients with intellectual disabilities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants in the intervention group receive a neurocognitive and psychosocial intervention module including cognitive retraining, cognitive-behavioral therapy, and marital/family counseling. The control group receives standard therapy without the intervention module.
Weekly visits lasting 2 hours each (in-person, group sessions)
Duration - 3 to 6 months after recruitment
Participants are followed up for outcome assessments, including pre and post neuropsychological and psychosocial evaluations to assess changes in quality of life and related measures.
At least 1 follow-up visit for assessments
Trial Site Locations
Total: 1 location
1
Post Graduate institute of medical education and research , Chandigarh
Chandigarh, India, 160012
Actively Recruiting
Research Team
N
Neetu Choudhary, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here