Efficacy of hypnotherapy compared to cognitive-behavioural therapy for mild-to-moderate depression: study protocol of a randomised-controlled rater-blind trial (WIKI-D)

Kristina Fuhr, Cornelie Schweizer, Christoph Meisner, Anil Batra, Kristina Fuhr, Cornelie Schweizer, Christoph Meisner, Anil Batra

Abstract

Introduction: Despite a substantial number of studies providing evidence for the efficacy of psychological treatment for mild-to-moderate depression, maximally only 50% of participants respond to treatment, even when using gold-standard treatments such as cognitive-behavioural therapy (CBT) and interpersonal therapy. New approaches such as the 'third wave' psychotherapies have provided promising results; however, studies concerning the comparison with evidence-based treatments are lacking. This study aims to compare the efficacy of clinical hypnotherapy (HT) with gold-standard psychotherapy (CBT) in the treatment of mild-to-moderate major depressive episodes.

Methods and analysis: The present study comprises a monocentric, two-armed, randomised-controlled, rater-blind (non-inferiority) clinical trial. A total of 160 participants with mild-to-moderate major depression episode will be randomly assigned to either CBT or HT involving 20 sessions of psychotherapy over a period of 24 weeks. We predict that the average improvement in the Montgomery-Åsberg Depression Rating Scale score will not be inferior in HT compared with CBT (non-inferiority hypothesis).Further outcome parameters will include the number of participants responding to treatment following the completion of treatment and 1 year after. Additionally, quality of life, treatment expectations and hypnotic susceptibility before and after end of treatment will be assessed.

Ethics and dissemination: The study protocol and the documents for the informed consent have been approved by the Ethics Committee of the University Hospital Tuebingen (061/2015B02). The results of this trial will be submitted for publication in peer-reviewed journals, and will be presented at national and international conferences.

Trial registration number: NCT02375308; Pre-results.

Keywords: cognitive-behavioural therapy; depression; hypnotherapy; psychotherapy.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Study flow chart. ACDT, activating cognitive depression therapy; ADP-IV, Assessment of DSM-IV Personality Disorders Questionnaire; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders—Fourth Edition; HDT, hypnotherapeutic depression therapy; LIFE, Longitudinal Interval Follow-Up Evaluation; MADRS, Montgomery-Åsberg Depression Scale; PHQ-9, Patient Health Questionnaire—Depression Scale; QIDS, Quick Inventory of Depressive Symptomatology; SCID-I,II, Structured Clinical Interview for DSM-IV Axis I,II.

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