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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants of 18 - 45 years of age.

either gender

Willing to participate and sign the informed consent

Disqualifiers

Patients with other neurological disorders

any other trial at inclusion

should not have any major psychiatric disorder

pregnant and lactating mothers

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
2 -3 years

Secondary outcomes

1

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

The Beck Depression Inventory scale was used to assess depression. It is a widely used self-report questionnaire designed to assess the severity of depression in individuals.a total score of 0-13 indicates minimal depression, 14-19 suggests mild depression, 20-28 reflects moderate depression, and a score of 29-63 signifies severe depression.

Time frame
2 -3 years
2

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

The Hamilton Anxiety Rating Scale was used to assess anxiety. It is a clinician-administered questionnaire used to assess the severity of anxiety symptoms. It consists of 14 items, each rated on a scale from 0 to 4, with higher scores indicating greater anxiety.

Time frame
2 -3 years
3

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

The Stigma Scale of Epilepsy was used to assess stigma. It is a self-report instrument designed to measure perceived stigma among individuals with epilepsy. It is scored by summing the responses to each of its 24 items, which are typically rated on a Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The total score can range from 24 to 96, with higher scores indicating a greater perception of stigma.

Time frame
2 -3 years
4

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

The World Health Organization Disability Assessment Schedule is a standardized instrument for assessing health and disability across various domains. It includes 36 items covering six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is rated on a scale from 1 (no difficulty) to 5 (extreme difficulty), and the total score ranges from 36 to 180, with higher scores indicating greater disability.

Time frame
2 -3 years

Other outcomes

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