RESUMO
A number of case studies describing hypnotherapy in the treatment of anxiety disorder patients have already been published. Only a few randomized controlled trials (RCTs) investigated the efficacy of hypnotherapy but focused mainly on symptoms rather than specific mental disorders. The goal of this study was to investigate whether hypnotherapy (HT) was superior to a waitlist control group (WL) in the reduction of agoraphobia-related symptoms. Further goals were to report the feasibility of hypnotherapy as well as attrition and completion rates and detect (epi-)genetic variables, which might play a role in treatment outcome. This pilot study was based on a monocentric two-armed randomized controlled rater-blind clinical trial that was conducted between 2018 and 2020 with a waitlist control group. A total of 36 patients diagnosed with agoraphobia were randomized to either HT or WL. Patients in HT received individual outpatient treatment with hypnotherapy with 8 to 12 sessions for a period of 3 months. Patients in WL received HT after 3 months. Agoraphobia-related symptoms were assessed at baseline, after the treatment, and 3 months later in both groups with a clinician rating. The primary hypothesis concerning the difference between groups in the individual percentage symptom reduction could be confirmed in the intention-to-treat, not the per-protocol sample. Additionally, we applied repeated-measures analyses of variance and found a higher symptom decrease in HT compared with WL patients in three of the five imputed datasets. The dropout rate was low, and satisfaction with the treatment was high. HT patients experienced a strong symptom reduction after receiving hypnotherapy. WL patients improved slightly during the waiting period. The COMT Val108/158Met genotype had an effect on the agoraphobia-related symptoms as well as on COMT DNA methylation levels. This is the first study to indicate that hypnotherapy performed better than a waitlist control group regarding the reduction in anxiety symptoms in an RCT. Future studies should confirm the efficacy of hypnotherapy and compare the treatment with a standard treatment for anxiety disorders in a larger trial. Future studies should also investigate whether hypnotic susceptibility is associated with COMT Val108/158Met genotype and could predict treatment success for HT. Clinical trial registration: https://classic.clinicaltrials.gov/ct2/show/NCT03684577, identifier: NCT03684577.
RESUMO
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.
