LAUSR

BACKGROUND Methodologically well-designed RCTs concerning the efficacy of Hypnotherapy in the treatment of Major Depression are lacking. The aim of this study was to determine whether Hypnotherapy (HT) is not inferior to Cognitive Behavioral Therapy (CBT), the gold-standard psychotherapy, in the percentage reduction of depressive symptoms, assessed in mild to moderate Major Depression (MD). METHODS This study reports the main results of a monocentric two-armed randomized-controlled rater-blind clinical trial. A total of 152 patients with MD were randomized to either CBT or HT receiving outpatient individual psychotherapy with 16 to 20 sessions for the duration of six months. The primary outcome was the mean percentage improvement in depressive symptoms assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) before and after treatment. RESULTS The difference in the mean percentage symptom reduction between HT and CBT was 2.8 (95% CI=-9.85 to 15.44) in the Intention-to-treat sample and 4.0 (95% CI=-9.27 to 17.27) in the Per Protocol sample (N=134). Concerning the pre-specified non-inferiority margin of -16.4, both results confirm the non-inferiority of HT to CBT. The results for the follow-ups six and twelve months after the end of the treatment support the primary results. LIMITATIONS For ethical reasons the trial did not include a control group without treatment; therefore we can only indirectly conclude that both treatment conditions are effective. CONCLUSION This is the first study to demonstrate that HT was not inferior to CBT in MD, while employing rigorous methodological standards.