NCT03484039.

Study name	Incorporating multidimensional psychosocial interventions improves the well‐being of individuals with epilepsy
Methods	Parallel assignment, randomised
Participants	568 participants
Interventions	Patients will be enrolled in 1 module of own choice. Except for Module 3 Submodule 2, every module will consist of a particular intervention, as well as its accompanying set of assessments. Prior to being given the intervention, participants assigned to a given module will be randomly assigned to either an Immediate Intervention (II) or a Delayed Intervention (DI) group. Although every participant will receive the intervention, the timing of the intervention and assessments will distinguish the II and DI group. The II group will receive the module (a 1‐2‐h course on either medication adherence, seizure documentation, memory improvement or stress management) right after a baseline assessment. A post‐assessment and delayed post‐assessment will be conducted after the module is administered. The DI group will receive a baseline assessment. 6 weeks‐3 months later (average 2 months) a pre‐intervention assessment will be conducted just prior to administering the modules (a 1‐2‐h course on either medication adherence, seizure documentation, memory improvement or stress management). A post‐intervention assessment will then be administered.
Outcomes	Changes in Quality of Life in Epilepsy‐10 scores (time frame: to be administered at baseline (upon participant screening), pre‐intervention (with 2 weeks prior to intervention), post‐intervention (between 6 weeks to 3 months post‐intervention), and delayed post‐intervention (within 4.5‐6 months post‐intervention)) This is a well‐validated measure of quality of life for people with epilepsy. The unit of measure is a composite score ranging from 0‐100 with higher scores indicating better QoL. Adherence was mentioned in the introduction as an outcome but not listed under primary outcomes.
Starting date	6 June 2018
Contact information	Ramon E Bautista, MD 904‐244‐9190 ramon.bautista@jax.ufl.edu
Notes