RESUMEN
INTRODUCTION: Psychological interventions are shown to be effective in migraine, but not utilized routinely yet. We aimed to evaluate the efficacy of transdiagnostic cognitive behavioral therapy (TCBT) on people with migraine (PwM). METHOD: This study was conducted on 40 PwM aged 20-50 years. We randomly assigned participants to two groups of intervention, receiving 10 sessions of TCBT, and control, attending one session on relaxation and stress-management techniques. Days with headache, headache severity, migraine-related disability and effects on daily life, number of pain-relivers taken for headache, depression, and anxiety were assessed pre-intervention, post-intervention (three-month follow-up), and one-month after TCBT termination (four-month follow-up). RESULTS: Thirty-five participants suffering moderate to severe migraine completed the study (16 and 19 in TCBT and control groups, respectively). TCBT improved all measured items between study time-points (p < 0.05) in the intervention group, while such an improvement was not observed in the control group. Between group comparisons revealed superiority of TCBT group compared to the control group in most measured items at three- and four-month follow-ups (p < 0.05). CONCLUSION: Ten sessions of TCBT improved migraine severity, associated disability, anxiety, and depression in PwM, with persistent effects after one month of therapy termination. However, the generalizability of these findings is limited due to the placebo effect in the intervention arm, given the more time each participant has spent with the therapist. TCBT could be an affordable, practical, and feasible intervention to be utilized for PwM and larger studies with equal number of sham therapy sessions are needed to further explore this. TRIAL REGISTRATION NUMBER: The study protocol was registered in clinicaltrial.gov ( NCT03701477 ) prior to enrollment.