Develop and Assess the Efficacy of a Neuro-cognitive and Psychosocial Intervention Module in Patients with Drug-resistant Epilepsy: A Randomized Controlled Trial
Objective:
This study aimed to develop and evaluate the efficacy of a
neuro-cognitive and psychosocial intervention module through randomized controlled trial, tailored specifically for patients
with DRE
Background:
Drug-resistant epilepsy poses significant challenges to patients' quality of
life, cognitive functioning, and psychosocial well-being. Cognitive impairments,
including attention, memory, and executive dysfunction, along with psychosocial
challenges such as stigma, anxiety, and depression, significantly impact daily functioning
and overall health outcomes.
Design/Methods:
The study was conducted in three phases at the Department of Neurology,
PGIMER, Chandigarh. Phase I involved the development of a neuro-cognitive and
psychosocial intervention module, incorporating psychoeducation, cognitive retraining
exercises, cognitive-behavioral therapy, and family counseling. Expert validation and
pilot testing were conducted to refine the module. Phase II included a pilot study to assess
the module's feasibility with a small sample of five patients. Phase III assessed the
efficacy of the module through a randomized controlled trial with 60 DRE patients,
randomly assigned to intervention (n=30) and control (n=30) groups. The intervention
group received the module along with standard medical treatment, while the control
group received only standard care. Pre- and post-intervention assessments were
conducted using validated tools, including QOLIE-31, Beck Depression Inventory,
Hamilton Anxiety Rating Scale, and various neurocognitive tests for attention, memory
and executive functions.
Results:
The intervention group showed significant improvements in quality of life, cognitive functioning
and psychosocial well-being. Statistically significant reductions were observed in anxiety and stigma scores.
Cognitive functions, including attention, memory, and executive functions, also improved
after 8 weeks for combined intervention.
Conclusions:
This study developed a simple neuro-cognitive and psychosocial module for
improving quality of life in drug-resistant epilepsy patients. This intervention module is
able to improve patient’s quality of life, cognitive functioning, and psychosocial wellbeing.
Overall, it proved to be both effective and feasible.
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