Reducing Distress from Auditory Verbal Hallucinations: A Multicenter, Parallel, Single-Blind, Randomized Controlled Feasibility Trial of Relating Therapy

Tania Marie Lincoln; Björn Schlier; Rebecca Müller; Mark Hayward; Anne-Katharina Fladung; Niklas Bergmann; Kerem Böge; Jürgen Gallinat; Candelaria Mahlke; Uwe Gonther; Thomas Lang; Cornelia Exner; Anika Buchholz; Katharina Stahlmann; Antonia Zapf; Geraldine Rauch; Matthias Pillny

doi:10.1159/000539809

Reducing Distress from Auditory Verbal Hallucinations: A Multicenter, Parallel, Single-Blind, Randomized Controlled Feasibility Trial of Relating Therapy

Psychother Psychosom. 2024;93(5):328-339. doi: 10.1159/000539809. Epub 2024 Aug 21.

Authors

Tania Marie Lincoln¹, Björn Schlier^{1

2}, Rebecca Müller¹, Mark Hayward^{3

4}, Anne-Katharina Fladung¹, Niklas Bergmann⁵, Kerem Böge⁵, Jürgen Gallinat⁶, Candelaria Mahlke⁶, Uwe Gonther⁷, Thomas Lang^{8

9}, Cornelia Exner¹⁰, Anika Buchholz¹¹, Katharina Stahlmann¹¹, Antonia Zapf¹¹, Geraldine Rauch¹², Matthias Pillny¹

Affiliations

¹ Clinical Psychology and Psychotherapy, Institute of Psychology, Faculty of Psychology and Human Movement Science, Universität Hamburg, Hamburg, Germany.
² Clinical Child and Adolescent Psychology and Psychotherapy, Bergische Universität Wuppertal, Wuppertal, Germany.
³ R&D Department, Sussex Partnership NHS Foundation Trust, Sussex Education Centre, Hove, UK.
⁴ School of Psychology, University of Sussex, Brighton, UK.
⁵ Department of Psychiatry and Neurosciences, Charité - Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.
⁶ Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁷ AMEOS Klinik Dr. Heines, Fachkrankenhaus für Psychiatrie, Psychotherapie und Psychosomatik, Bremen, Germany.
⁸ Christoph-Dornier-Foundation for Clinical Psychology, Institute for Clinical Psychology Bremen;, Bremen, Germany.
⁹ Department for Psychology and Methods, Jacobs University Bremen, Bremen, Germany.
¹⁰ Department of Clinical Psychology and Psychotherapy, University of Leipzig, Leipzig, Germany.
¹¹ Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
¹² Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.

Abstract

Introduction: There is a significant demand for interventions that reduce distress related to auditory verbal hallucinations (AVHs). AVH distress is associated with the way voice hearers relate with AVHs. We aimed to establish the feasibility of a randomized controlled trial to demonstrate that adding "Relating Therapy" (RT) to treatment as usual (TAU) is superior to TAU in reducing AVH distress.

Methods: We conducted a multicenter, parallel, single-blind, randomized controlled feasibility trial in five mental health centers in Germany. Participants were ≥19 years of age, had persistent and distressing AVHs, and had a diagnosis of a schizophrenia-spectrum disorder. RT was delivered over a maximum of 16 sessions within 5 months. Blind assessments were conducted at baseline and at 5 and 9 months. Feasibility outcomes were the number of patients recruited and retained, and safety and therapist adherence. The primary endpoint was the distress factor score of the AVH subscale of the Psychotic Symptoms Rating Scales at 9 months.

Results: Eighty-five of 177 enrolled participants were randomized into RT + TAU (n = 43) or TAU (n = 42). Feasibility was excellent with 87% retention at 9 months, 86% reaching treatment uptake criteria, 98% therapist adherence, and no unexpected serious adverse reactions. Compared to TAU, RT + TAU showed nonsignificant trends toward less AVH distress (b = -2.40, SE = 1.52, p = 0.121, 90% CI (-4.94 to 0.15) and stronger improvement on all but one of the secondary outcomes.

Conclusion: A randomized controlled trial of RT is feasible, safe, and well accepted. Our results provide an encouraging basis to further test the efficacy of RT in a definitive multicenter trial.

Keywords: Hallucinations; Psychosis; Psychotherapy; Randomized-controlled trial; Relating.

Publication types

Randomized Controlled Trial
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Feasibility Studies*
Female
Germany
Hallucinations* / therapy
Humans
Male
Middle Aged
Psychological Distress
Schizophrenia* / therapy
Single-Blind Method
Stress, Psychological / therapy
Treatment Outcome

Grants and funding

This project was funded by the German Research Foundation under its Research for Clinical Studies Programme (Project No. LI 1298/9-1; Grant Reference No. PB-LI1298/9-1). The funder had no role in the design, data collection, data analysis, and reporting of this study.