title: Behavioral intervention as an add-on therapy in epilepsy: designing a clinical trial.
abstract: Many patients with epilepsy continue to experience seizures despite taking medication, and stress is a commonly reported trigger for seizures in these individuals. Therefore, a behavioral therapy proven to be effective in epilepsy could be a valuable adjunct to current pharmacotherapy. The challenges in testing such a behavioral intervention for epilepsy are numerous, including lack of consensus about sham designs, maintaining the blind, and powering the study absent known effect sizes. Herein, we present the design of a randomized, controlled, double-blind trial of progressive muscle relaxation as an add-on therapy for refractory epilepsy. Progressive muscle relaxation, which involves the tensing and releasing of muscle groups one at a time, is a well-established technique that relaxes the body and mind, reduces stress, and may improve seizure control. Study design issues discussed may provide insights that will inform future behavioral research in epilepsy.
authors.affiliation: Montefiore-Einstein Epilepsy Center, Montefiore Medical Center and the Albert Einstein College of Medicine, Bronx, NY, USA.
authors.forename: Emily L
authors.initials: EL
authors.lastname: Polak
authors.forename: Michael D
authors.initials: MD
authors.lastname: Privitera
authors.forename: Richard B
authors.initials: RB
authors.lastname: Lipton
authors.forename: Sheryl R
authors.initials: SR
authors.lastname: Haut
mesh_terms: D000328:Adult; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004827:Epilepsy / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012064:Relaxation Therapy / Q000379:methods*; D012640:Seizures / Q000209:etiology / Q000517:prevention & control; D013315:Stress, Psychological / Q000150:complications / Q000517:prevention & control