Title: A feasibility and acceptability study of the Talking With Voices intervention amongst adults with psychosis.
Funder: Department of Health and Social Care

Abstract: Aims. To test feasibility and acceptability of a specific intervention, Talking With Voices (TwV), for helping patients with a diagnosis of schizophrenia cope with distressing voices (auditory hallucinations). The results will inform proposals for running a definitive randomised trial to assess effectiveness and clinical impact.Background: Although medication is a first-line treatment response for voice hearing many patients do not respond well to antipsychotics, particularly those with high levels of trauma exposure. Similarly, NICE guidelines recommend that patients with schizophrenia are offered CBT; however, not all patients engage with CBT and a further proportion do not benefit from receiving it. In this regard, it is increasingly acknowledged that voice hearing interventions should address the psychological sequelae of adverse life events, which are known to be strongly associated with schizophrenia generally and voice hearing specifically. Finally, a growing body of theoretical and experimental work in the past decade has argued that dissociation is a central factor for hallucinatory experiences in both non-patient and trans-diagnostic patient groups. Taken together, the considerable conceptual and clinical overlaps between voice hearing experiences in the context of dissociative disorders, psychosis/schizophrenia, and posttraumatic stress has supported the claim that rigid distinctions in treatment strategies according to diagnosis are theoretically and therapeutically unjustified. TwV is a form of psychotherapy that approaches voice hearing in schizophrenia in a manner considered customary within treatment for dissociative disorders; that is, a therapist verbally engages with voices in a way that is intended to instigate integration and reconciliation, enhance awareness of voice characteristics, examine relevant factors in voice emergence/maintenance, and redress unequal power dynamics between hearer and voice. Psychological formulation and psychosocial education are also utilized. The intervention has a robust theoretical rationale and is consistent with the growing clinical emphases on the impact of traumatic representations in the positive symptoms of schizophrenia. However, although TwV is applied and advocated within the International Hearing Voices Movement (a grass-roots support and activism network of voice hearers and their allies, in which the intervention originated) it awaits controlled evaluation.Design and methods: Feasibility and acceptability will be assessed using a randomised control single-blind (rater) design. Participants will be recruited who have previously been offered CBT but chosen not to have it, or who have received it but are still experiencing distressing voices. The trial will have a recruitment window of 15 months, requiring approximately three participants with diagnoses of schizophrenia-spectrum disorders per month. The proposed sample is adequate for obtaining reliable parameters for sample size estimates for the definitive trial, and demonstrating the feasibility of such a trial. Participants will be randomly allocated to receive either the intervention (n=25) or treatment as usual (n=25). Up to 26 sessions will be delivered over six months. The primary outcome will be quantitative and qualitative assessments of feasibility and acceptability amongst patients and NHS staff. Secondary outcomes will involve clinical measures, including targeted instruments for voice hearing, dissociation, emotional distress and recovery, which will be used to inform outcomes for a definitive trial.Potential benefit: Schizophrenia is estimated to cost the UK 11.8 billion a year, with treatment refractory voices associated with significant distress and debilitation. TwV addresses a need that is insufficiently addressed by current NICE recommended pharmacological/psychological interventions for schizophrenia by engaging dialogically with voices in order to target dissociation, address traumatic representations, and create a more positive, peaceful relationship between hearer and voice. Findings will be used to inform the feasibility and design of a future definitive, pragmatic, clinical, and cost-effectiveness trial. If shown to be safe and effective, TwV could be a significant advance in treating a vulnerable, clinically disadvantaged group.

Lay abstract: Aims: People with a diagnosis of schizophrenia often hear distressing voices which no one else can hear. This project aims to understand if it is possible to support them using a new form of therapy called Talking With Voices (TwV).Background: Schizophrenia, a form of psychosis, causes great distress for patients and their families. It is also a challenge for the NHS and is estimated to cost the UK 11.8 billion a year. Drugs are the main treatment for people with this diagnosis and some patients are offered a talking therapy known as cognitive behavioural therapy (CBT). However, not everyone finds these approaches helpful. It is also now known that negative life events, like childhood abuse, can have a big impact on the risk of developing symptoms of schizophrenia. This means there is a need for safe, effective treatments that can support people with this diagnosis to cope with the effects of trauma. Hearing voices that no one else can hear is one symptom of schizophrenia that is strongly linked with traumatic events (for example, what the voices say can often reflect real-life negative experiences). This research will test a form of therapy for supporting people who hear distressing voices. TwV involves a therapist talking' to the voice by asking it questions. The voice hearer then listens to the responses and repeats them out loud to the therapist. Over time, the therapist learns more about the voice(s) in order to support the voice(s) and voice hearer to develop a more peaceful, positive relationship. In addition, the therapist and voice hearer work together to try and understand how the voices may relate to particular problems in the person's life. It is hoped that TwV could eventually help people feel more in control and less distressed by their voices. However, although there are strong grounds for believing that this would be the case, there is currently no evidence for using TwV within the NHS. It is therefore unclear if it would be feasible to run a large clinical trial of TwV, and what sort of questions would need to be asked to know whether a large trial had been successful.How the project will be run: The project will conduct a small trial to discover whether a larger study could be run in the future. Patients will be invited to take part if they have been offered CBT in the past but not wanted to try it or if they have received CBT and still hear distressing voices. The experiences of 25 people who receive TwV and standard NHS mental health care will be compared with 25 who receive standard NHS mental health care only. The group each person is put into will be decided by chance. The main questions to be answered are whether it is possible for NHS staff to use TwV, whether patients want to take part in the study, and if they find TwV helpful. This will be explored by looking at factors like how many therapy sessions patients attend, whether therapists are able to follow instructions for using TwV, and the reasons that patients choose, or not, to participate in the study. Other aspects of patients' lives will also be looked at, such as whether their relationship with their voices has become more positive, whether they are able to work or study, and if they are anxious or depressed. This information will be collected with questionnaires by researchers who are unaware of which group each participant is in. Interviews will also be used to get more detailed opinions from patients and NHS staff about their experiences during the study.Involving patients and the public: TwV began in the International Hearing Voices Movement. This is an organisation in which groups of voice hearers, family members, mental health workers, and researchers work together to promote more positive attitudes towards hearing voices and emphasise that it is possible to recover from the distress that voices can cause. The input of 'experts-by-experience' (people who hear voices, their friends and family members) and 'experts-by-profession' (mental health workers, researchers) will be gained from members of Intervoice (the organisational body of the Hearing Voices Movement). This advice will be used to help develop the research project. Further advice has been provided from a local service-user reference group, who meet regularly to offer ideas and feedback about research in the NHS.Sharing the findings: The research findings will be shared using articles in academic journals, conference presentations, workshops, social media, and via contacts with Intervoice.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH