Condition category
Mental and Behavioural Disorders
Date applied
11/12/2017
Date assigned
15/12/2017
Last edited
15/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Schizophrenia, a form of psychosis, is a considerable challenge for the NHS which is estimated to cost the UK £11.8 billion a year. One of the main symptoms of schizophrenia is hearing voices that others do not hear. Drugs are currently the main treatment and some patients are offered a talking therapy known as cognitive behavioural therapy (CBT). However, not everyone finds these approaches helpful. It is also known that negative life events, like childhood abuse, significantly increase 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 emotional impact 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 therapy for supporting people who hear distressing voices called Talking With Voices (TwV). It involves a therapist ‘speaking’ 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. It is hoped that TwV could eventually help people feel more in control and less distressed by their voices. However, while there are strong theoretical grounds for believing that this would be the case, there is currently no evidence for using TwV within the NHS and it is unclear if it would be feasible to run a large clinical trial or what sort of questions would need to be asked to know whether it had been successful. The aim of this study project is to conduct a small trial to discover whether a larger study could be run in the future.

Who can participate?
Adults aged 18 and older who have been diagnosed with schizophrenia.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive treatment as usual. Those in the second group receive the TwV programme. This includes up to 26 sessions with a clinical psychologist of up to an hour over a six month period. Participants are assessed before and after the treatment at six months.

What are the possible benefits and risks of participating?
Participants randomised to the treatment arm have the potential benefit of receiving a novel, specialised psychological therapy for voice hearing delivered by practitioners with extensive experience in supporting individuals with psychosis. The investigators consider the likelihood of risk from treatment to be minimal and will arrange therapeutic management within NHS safeguarding frameworks. GPs and healthcare staff from the participants' care teams will be made aware of a particular client’s involvement to ensure participants have the opportunity to discuss any issues that may have arisen as a result of taking part in the study. Protocols will additionally be put in place in advance in the event of a serious adverse event and/or participants wishing to withdraw from the trial. Participation in the trial does not change existing treatment receipt, so there is no disadvantage in taking part. There is a risk of burden during the assessments, and to minimise possible fatigue or stress participants will be offered breaks, given flexibility in the timing/venue for appointments, and be reminded that they can stop at any time. If indicated, assessment can be spread over several days. A small financial incentive (£10) will also be provided per assessment. Assessments will be administered by trained staff and will identify any risks to self/others that require immediate action. All participants will additionally receive a crisis card providing contact details for appropriate sources of help in psychiatric emergency.

Where is the study run from?
This study is being run by the Greater Manchester Mental Health NHS Foundation Trust (UK) and takes place in GP surgeries in the Greater Manchester area.

When is the study starting and how long is it expected to run for?
October 2016 to September 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Eleanor Longden
eleanor.longden@gmmh.nhs.uk

Trial website

www.psychosisresearch.com

Contact information

Type

Scientific

Primary contact

Dr Eleanor Longden

ORCID ID

Contact details

Greater Manchester Mental Health NHS Foundation Trust
Psychosis Research Unit
Rico House
Bury New Road
Prestwich
M25 3BL
United Kingdom
+44 161 358 1395
eleanor.longden@gmmh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36518

Study information

Scientific title

A feasibility and acceptability study of the Talking With Voices intervention amongst adults with psychosis

Acronym

Study hypothesis

The aim of the present research is to evaluate the feasibility and acceptability of the Talking With Voices intervention in NHS settings amongst individuals with a diagnosis of schizophrenia spectrum disorder who hear distressing voices.

Ethics approval

North West - Preston Research Ethics Committee, 07/11/2017, ref: 17/NW/0633

Study design

Randomised; Both; Design type: Treatment, Psychological & Behavioural, Validation of investigation /therapeutic procedures

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Mental health, Primary sub-specialty: Psychosis - schizophrenia; UKCRC code/ Disease: Mental Health/ Schizophrenia, schizotypal and delusional disorders

Intervention

Randomisation is done in the ratio 1:1 to the two groups and is independent and concealed using randomised-permuted blocks of 6-8 administered via an encrypted web-based system. Participants are then allocated to one of two treatment arms:
1. Treatment as usual (TAU) only. Although this varies according to different clinical sites, TAU for schizophrenia/psychosis in community mental health team settings is based on the care programme approach to case management and typically includes antipsychotic medication prescribed by a psychiatrist, access to rehabilitative services, outpatient follow-up care, and the assignment of community psychiatric nurses and social workers.
2. Psychological intervention (‘Talking With Voices’) plus TAU. The intervention includes up to 26 sessions with a clinical psychologist of up to an hour over a six month period. Sessions focus on (1) psychosocial education, with an emphasis on normalising and de-shaming the voice hearing experience and providing coping and recovery literature, (2) psychological formulation, which involves the therapist and client co-constructing a shared understanding of what social/emotional conflicts the voices may represent, and (3) dialogical engagement with voices, wherein the therapist communicates directly with the voices by asking them questions and requesting the participant to repeat their responses. Participants are seen by the same therapist for the duration of the study to maintain engagement and consistency of approach.

All participants are invited to a research assessment with a blind (independent) assessor. These take place at baseline and then again at six months post-randomisation.

Intervention type

Other

Phase

Drug names

Primary outcome measures

As this is a feasibility trial, a single primary outcome is not meaningful. Key outcomes to inform the design of a future definitive trial are:
1. Referral rates and recruitment rates, which will be assessed at the end of the recruitment period in April 2019.
2. Attendance at, and engagement with, therapy sessions; and follow-up and questionnaire response rates, which will be assessed at the end of the follow-up period in October 2019.
3. Acceptability of treatment, which will be assessed using drop-out rates at the end of the follow-up period by October 2019.

Secondary outcome measures

All secondary outcomes are being collected to determine their suitability for use in a subsequent trial, rather than to draw conclusions about the safety or efficacy of the intervention:
1. Relationship with voices is measured using The Voice and You scale (VAY) at baseline and at six months post randomisation
2. Beliefs about voices are measured using The Revised Beliefs about Voices Questionnaire (BAVQ-R) at baseline and at six months post randomisation
3. Voice hearing phenomenology is measured using The Subtypes of Voice Hearing Questionnaire (SOV-Q) at baseline and at six months post randomisation
4. Dissociation is measured using The Revised Dissociative Experiences Scale (DES-II) at baseline and at six months post randomisation
5. Psychotic symptomology is measured using The Positive and Negative Syndrome Scale (PANSS) at baseline and at six months post randomisation
6. Social and occupational functioning is measured using The Questionnaire about the Process of Recovery (QPR) at baseline and at six months post randomisation
7. General health status is measured using the EQ-5D at baseline and at six months post randomisation

Overall trial start date

01/10/2016

Overall trial end date

30/09/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged ≥18
2. Have heard voices for at least one year and score ≥4 on the auditory hallucination subscale of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
3. Have had no changes to medication within the past month
4. Have a lifetime diagnosis of ICD schizophrenia spectrum disorder
5. Able to provide written, informed consent
6. Not currently receiving, or waiting to receive, cognitive behavioural therapy for psychosis
7. Willing and able to communicate with their voices and relay what the voices say to a therapist
8. Whose voices are sufficiently personified to engage in dialogical work (i.e. voices which can engage in conversation and dynamically interact with the hearer)
9. No restrictions have been placed on recruitment according to gender

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

Participant exclusion criteria

1. At immediate risk of harm to self or others
2. Non-English speaking
3. Primary diagnosis of alcohol/substance dependence or autism spectrum disorder
4. Moderate/severe learning disability
5. Organic brain injury or illness implicated in the aetiology of psychotic symptoms
6. A score of > 5 on the conceptual disorganisation subscale of the Positive and Negative Syndrome Scale for Schizophrenia
7. Homeless and/or of no fixed abode

Recruitment start date

15/01/2018

Recruitment end date

15/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Greater Manchester Mental Health NHS Foundation Trust
Harrop House Bury New Road Prestwich
Manchester
M25 3BL
United Kingdom

Sponsor information

Organisation

Greater Manchester Mental Health NHS Foundation Trust

Sponsor details

Research & Innovation Office
Harrop House
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. Please find a copy of the protocol attached. A statistical analysis plan is not currently available, but will be provided to the ISRCTN in due course.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/09/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/12/2017: Uploaded protocol Version 2 23 Nov 2017 (not peer-reviewed).