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 December 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
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
Schizophrenia spectrum disorder
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 measure
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.
Added 27/06/2019:
Progression criteria relate to recruitment, retention, adherence and data completeness and will have stop/refine/go (red/amber/green) criteria. The suggested criteria and cut-offs are:
1. Recruitment: Green >= 80% of target; Amber 60-79%; Red <= 59%
2. Retention (at the six month assessment point with the PANSS): Green >= 80%; Amber 60-79%; Red <= 59%
3. Intervention adherence: Green >= 80% attending at least 8 sessions; Amber 60-79%; Red <= 59%. Eight sessions has been agreed to constitute a therapeutic ‘dose’
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
30/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 15/05/2019:
1. Adults aged ≥18 years
2. Who have heard voices for at least one year and score ≥4 on the auditory hallucination subscale of the Positive and Negative Syndrome Scale (PANSS)
3. Who have had no changes to medication within the past month
4. Who meet criteria for ICD schizophrenia spectrum disorder
5. Who are able to provide written, informed consent
6. Who are not currently receiving structured psychological therapy for psychosis
7. Who are in contact with secondary care mental health services and have a care coordinator
8. Who are willing and able to communicate with their voices and relay what the voices say to a therapist
9. Whose voices are sufficiently personified to engage in dialogical work (i.e., voices which can engage in conversation and dynamically interact with the hearer)
Previous inclusion criteria from 07/06/2018 to 15/05/2019:
1. Aged ≥18 years
2. Has heard voices for at least 1 year and score ≥4 on the auditory hallucination subscale of the Positive and Negative Syndrome Scale (PANSS)
3. Has had no changes to medication within the past month
4. Meets criteria for ICD schizophrenia spectrum disorder
5. Able to provide written, informed consent
6. Not currently receiving structured psychological therapy for psychosis
7. In contact with secondary care mental health services and has a care coordinator
8. Willing and able to communicate with the voices and relay what the voices say to a therapist
9. Voices are sufficiently personified to engage in dialogical work (i.e. voices that can engage in conversation and dynamically interact with the hearer)
Original 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
Total final enrolment
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
30/12/2019
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
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
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
30/12/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN45308981_PROTOCOL_V2_23Nov17.pdf Uploaded 15/12/2017
- ISRCTN45308981_Protocol_V5_26Apr18.pdf Uploaded 07/06/2018
- ISRCTN45308981_PROTOCOL_V7_28Nov19.pdf Uploaded 12/02/2020
- ISRCTN45308981_SAP_V3_19Jun18.pdf Uploaded 19/02/2020