Condition category
Mental and Behavioural Disorders
Date applied
16/01/2020
Date assigned
22/01/2020
Last edited
22/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
The researchers have developed a new talking therapy (Avatar therapy) that aims to help people who hear distressing voices. Avatar therapy involves building an image or 'avatar' of the distressing voice that the person hears on a computer and then, with help from a therapist, the person is given the opportunity to talk to the avatar. Over time, the person is supported to stand up more to the avatar with the hope that they will feel less anxious or upset when hearing the voice in their everyday life. The researchers are trying to find out how many sessions of AVATAR therapy is most helpful for people, so in this trial people will be offered either six (low intensity) or twelve (high intensity) sessions. In between sessions people are given recordings of their conversations with the avatar that they can listen to as an extra source of support.

To see if Avatar therapy is helpful, people from four NHS areas (South London, North London, Manchester and Glasgow) who have agreed to take part in the project will be randomly chosen to continue receiving their usual care, to receive low intensity (6 sessions) Avatar therapy in addition to their usual care, or to receive high intensity (12 sessions) Avatar therapy in addition to their usual care. The purpose of this project is to see whether Avatar therapy helps people when added to the care they normally receive. The researchers would also like to learn more about how this intervention works for people.

Who can participate?
Patients aged 18 years or older, who have been hearing a distressing voice for longer than 6 consecutive months.

What does the study involve?
Everybody who takes part will meet with a project worker for an initial meeting and then after 4 and 7 months. At each meeting, they will be asked about their experiences of voices, their mood, things that worry them and their overall wellbeing. The researchers expect each of the meetings will take about an hour and a half. These can be shorter if the person would like, and they will also be offered breaks during the meetings. The researchers will try to do them at times and locations that are most convenient for them.
After each of these meetings the participant will be asked to complete questionnaires 10 times a day for the following 6 days using a smartphone which has been set up just for this. The researchers ask people to do this because it gives us a better understanding of how voices affect them in their everyday lives, and the researchers can see whether Avatar therapy is helpful in more detail. This is optional and if they do not want to do it they can still take part in the rest of the study.
After the first meeting, the participant will be randomly allocated by a computer to either continue with their usual care, receive low intensity Avatar therapy (6 sessions) and their usual care or to receive high intensity Avatar therapy (12 sessions) and their usual care. A member of the project team will tell them the outcome.

What are the possible benefits and risks of participating?
The researchers hope that those receiving Avatar therapy will find it helpful. However, this cannot be guaranteed. Everyone taking part in the trial including those who do not receive Avatar therapy will be reimbursed for their time. The information from all participants may help us to support others with similar problems. If Avatar therapy is shown to work, then the researchers plan to make it more widely available in NHS services in the future. The researchers do not anticipate that there are any risks in taking part. However, as standard practice, the university sponsoring the research has insurance arrangements in place to provide for any harm arising from taking part if it were to occur. NHS indemnity operates in respect of the therapy that is provided.

Where is the study run from?
1. Institute of Psychiatry, Psychology & Neuroscience, Kings College London, UK
2. University College London, UK
3. University of Manchester, UK
4. University of Glasgow, UK

When is the study starting and how long is it expected to run for?
October 2020 to August 2023

Who is funding the study?
The Wellcome Trust, UK

Who is the main contact?
Dr Clementine Edwards
clementine.edwards@kcl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Clementine Edwards

ORCID ID

http://orcid.org/0000-0001-9949-2401

Contact details

PO Box 77
Henry Wellcome Building
Institute of Psychiatry
Psychology & Neuroscience
Kings College London
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)7557866053
clementine.edwards@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 277118

Study information

Scientific title

Optimising AVATAR therapy for distressing voices: a multi-centre randomised controlled trial

Acronym

AVATAR2

Study hypothesis

1. AVATAR therapy at a high-intensity level will be more effective in reducing voice-related distress and voice frequency than Treatment As Usual (TAU) post-treatment (16 weeks) and at follow up (28 weeks)
2. AVATAR therapy at a low-intensity level will be more effective in reducing voice-related distress and voice frequency than TAU, post-treatment (16 weeks) and at follow up (28 weeks)
3. AVATAR therapy (both levels) will reduce anxiety related to voices, and improvements in outcome are mediated by anxiety reduction
4. High intensity AVATAR therapy will change the voice hearer’s relationship with the voice (as measured by the Experience Sampling Methodology (ESM) Questionnaire and the Voice Action and Acceptance scale (VAAS) and changes in this relationship will mediate outcome
5. Greater baseline complexity of voice characterisation will moderate the effects of high and low-intensity AVATAR therapy compared to TAU
6. PTSD symptomatology and/or perceived links between experiences of trauma and voices will moderate outcome
7. Both levels of AVATAR will have favourable incremental cost-effectiveness ratios compared to routine care

Ethics approval

Approval pending, HRA, (Ref: 277118)

Study design

A multicentre three-arm single-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

People with schizophrenia spectrum disorder or affective disorder with psychotic symptoms who have been experiencing distressing voices for longer than 6 months.

Intervention

People will be randomised to receive AVATAR therapy at high- or low-intensity added to Treatment As Usual (TAU) compared to TAU alone. Independent randomisation (King’s Clinical Trials Unit) will use randomly varying permuted blocks, stratified by site and baseline complexity of voice entity characterisation.

AVATAR Therapy is a computer-assisted treatment of auditory hallucinations in people with a diagnosis of psychosis (e.g. schizophrenia). The therapy involves a three-way conversation between therapist, patient and a digital simulation ('avatar') of one of his/her hallucinated voices. The therapist, sitting in a room remotely from the patient, speaks either as him/herself or in his/her digitally transformed voice as the avatar. The patient sits in front of a monitor on which the avatar appears. The avatar changes over time to be less intimidating and persecutory in response to changes in the participant’s responses, guided by the therapist. The voice-hearer is supported throughout by the therapist who, while physically located in another room, uses visual (webcam) and audio feedback to adjust the dialogue to ensure optimal engagement.
The AVATAR therapy will be delivered at two levels (one in each arm of the trial) – low intensity and high intensity. The low-intensity AVATAR therapy will be delivered over 6 sessions and will focus on exposure to the avatar speaking aloud verbatim voice content while the therapist supports the person to adopt an assertive role and stand up to the avatar. The high-intensity AVATAR therapy will incorporate this exposure phase but be extended to 12 sessions. The additional sessions will comprise of increasingly elaborated dialog based on a formulation that takes account of the person’s beliefs about the identity, power and malevolence of the voices and of what might persuade the avatar to take a more conciliatory and accepting view of the person.

During the trial, therapy will be delivered by trained and experienced therapists, with expertise in working with this client group, who will attend peer supervision with the project team for the duration of the studies. The therapy will not interfere with the usual care offered through mental health services and no attempt to control the delivery of other services to either group will be made.

Duration of treatment and follow-up:
In the low-intensity arm participants will receive 6 sessions (over 12 weeks) of AVATAR therapy, in the high-intensity arm participants will receive 12 sessions (over 16 weeks) of AVATAR therapy. Follow-up assessments will be conducted at 16 weeks and 28 weeks, there are no follow up therapy sessions.

Intervention type

Device

Phase

Phase II/III

Drug names

AVATAR software

Primary outcome measure

Distress associated with voices as measured by the Psychotic Symptoms Rating Scale- Auditory Hallucinations at 16 and 28 weeks

Secondary outcome measures

1. Frequency of voices as measured by the Psychotic Symptoms Rating Scale - Auditory Hallucinations at baseline, 16 and 28 weeks
2. Remission of voices (standalone item) at baseline,16 and 28 weeks
3. Beliefs about Voices Revised (BAVQ-R) at baseline, 16 and 28 weeks
4. Voices acceptance and action scale (VAAS) at baseline, 16 and 28 weeks
5. First item from the Voice Power Differential Scale at baseline, 16 and 28 weeks
6. In daily life, occurrence of voices, associated distress and anxiety, using Experience Sampling Method at quasi-random occasions during the waking day over a 7-day period at baseline, 16 and 28 week assessment points
7. Wellbeing and patient-led outcome measures i.e. Warwick-Edinburgh Mental Well-being Scale, Choice of Outcome in CBT for Psychoses (CHOICE) at baseline, 16 and 28 weeks
8. Clinical characteristics and hypothesised sources of moderation of effects i.e. mood (Beck Depression Inventory) , anxiety (DASS-21), delusions (PSYRATS), trauma (e.g. International Trauma Questionnaire and negative symptoms (Clinical Assessment Interview for Negative Symptoms) at baseline, 16 and 28 weeks

Overall trial start date

01/06/2020

Overall trial end date

31/07/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18+ years
2. Currently under the care of a specialist mental health team (inpatient and outpatient settings)
3. Have current frequent and distressing voices, (as measured by a score of at least 2 on the sum of the intensity of distress and frequency items of the PSYRATS (Voices) scale), persisting for at least 6 months and in a language spoken by the therapist
4. Speak and read English to a sufficient level to provide consent and complete the assessment procedures
5. A clinical diagnosis of Schizophrenia spectrum disorder (ICD10 F20-29) or affective disorder with psychotic symptoms (ICD-10 F30–39, subcategories with psychotic symptoms)- as determined by clinical records

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

345

Participant exclusion criteria

1. Primary diagnosis of substance disorder, personality disorder or learning disability
2. Lacking capacity to consent
3. Profound visual/hearing impairment or insufficient comprehension of English to be able to engage in assessment or therapy
4. Currently undertaking individual psychological therapy for voices
5. Currently experiencing an acute mental health crisis

Recruitment start date

01/10/2020

Recruitment end date

31/08/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Kings College London
Institute of Psychiatry, Psychology & Neuroscience De Crespigny Park
London
SE5 8AF
United Kingdom

Trial participating centre

University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom

Trial participating centre

University of Manchester
Zochonis Building
Manchester
M13 9GB
United Kingdom

Trial participating centre

University of Glasgow
Gartnavel Royal Hospital
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
+44 (0)2078483224
reza.razavi@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Organisation

South London and Maudsley NHS Foundation Trust

Sponsor details

R&D Department
Institute of Psychiatry
Psychology & Neuroscience
King's College London
Denmark Hill Campus
16 De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)2078480339
slam-ioppn.research@kcl.ac.uk

Sponsor type

Other

Website

http://www.slam.nhs.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Wellcome

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

It is intended that the results of the study will be reported and disseminated at international conferences and in peer-reviewed scientific journals and will be made available to participants and clinical teams in an accessible format and on the study website. It will also be accessible in print and digital media and presented at stakeholder’s events.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Following publication of the main trial paper the anonymised datasets will be available upon receipt of a reasonable request from Professor Philippa Garety (Principal Investigator) – philippa.garety@kcl.ac.uk

Intention to publish date

31/07/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/01/2020: Trial’s existence confirmed by the Wellcome Trust