Condition category
Mental and Behavioural Disorders
Date applied
15/03/2013
Date assigned
27/03/2013
Last edited
13/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The experience of distressing voices that persist despite medical treatment is a serious problem for many patients suffering from severe mental health problems. Avatar therapy is a new computer-assisted therapy that has shown some benefit in a small pilot study. The aim of this study is to test whether avatar therapy is more effective than supportive counselling.

Who can participate?
Anyone aged over 18 who has experienced voices speaking in English that have persisted for at least 12 months despite medical treatment.

What does the study involve?
After consenting to take part, participants are asked questions about the voices they hear, their mental and physical health and how the voices affect their quality of life. Participants are then randomly allocated to either avatar therapy or supportive counselling. Participants allocated to the avatar therapy are helped to use a computer program to develop an 'avatar' (image and voice) similar to the person or entity whose voice bothers them. The therapist uses this avatar in the therapy sessions to talk with them and help them to practice ways of coping with the voices. Participants allocated to supportive counselling do not create or use the avatar but talk with the therapist about the voice, their everyday life and how they are feeling more generally. Both types of treatment are given over six sessions of a half-hour each. All treatment sessions are recorded and participants are given these recordings on a small MP3 player to take away to use on their own at any time. After the six therapy sessions a researcher asks them the same questions they were asked before they started therapy. Participants are contacted again at 12 weeks and 6 months from when they joined the study to see whether any improvement has continued. Participants also provide their views about the therapy and how it may be improved in future.

What are the possible benefits and risks of participating?
The possible benefits are reductions in the frequency, severity and distress caused by the voices. The risks are that the treatment may be distressing and may not be effective.

Where is the study run from?
Clinics in the South London and Maudsley NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
June 2013 to June 2016

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Prof. Thomas J Craig
Thomas.Craig@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Jamieson Craig

ORCID ID

Contact details

PO 33 HSPRD
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
-
thomas.craig@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Reducing the frequency and severity of auditory hallucinations: a randomised clinical trial of a novel Audio-Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR) compared to supportive counselling

Acronym

AVATAR

Study hypothesis

AVATAR therapy will result in a greater decrease in the frequency and subjective severity of auditory hallucinations than is achieved by supportive counselling.

Ethics approval

NRES Committee London - Hampstead, 26/04/2013, REC ref: 13/LO/0482

Study design

Single-centre pragmatic two-arm observer-blind randomised controlled trial

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 to request a patient information sheet

Condition

Severe mental illness

Intervention

1. AVATAR therapy: an average of 6 x ½ hour weekly sessions
2. CONTROL therapy: supportive counselling also for 6 x ½ hour weekly sessions
Six sessions of a half an hour each, once per week

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 21/09/2017:
Total score on the auditory hallucinations component of the Psychotic Symptoms Rating Scale PSYRATS-AH (Haddock et al., 1999), measured at baseline, 12 weeks and 6 months

Previous primary outcome measures:
Total score on the auditory hallucinations component of the Psychotic Symptoms Rating Scale PSYRATS-AH (Haddock et al., 1999), measured at baseline, 8 weeks, 12 weeks and 6 months

Secondary outcome measures

Current secondary outcome measures as of 21/09/2017:

Voices outcomes:
1. Beliefs about Voices Revised BAVQ-R (Chadwicket al., 2000)
2. Voices Acceptance and Actions Scale (Shawyer et al., 2007)
3. Voice power differential scale (Birchwood et al., 2000)

Global:
1. Scales for the Assessment of Positive and Negative Symptoms (SAPS/SANS - Andreasen,1984)
2. Psychotic Symptoms Rating Scale- Delusions (Haddock et al., 1999)
3. Modified Illness Perceptions Questionnaire (Watson et al 2006, Marcus et al 2014)
4. Calgary Depression Scale (Addington et al., 1993)

Quality of life:
1. Manchester Short Assessment of Quality of Life - MANSA (Priebe et al., 1999)
2. EQ5-D (EuroQol, 1999)

Service use:
Client service receipt inventory (Beecham and Knapp, 2001)

Measured at baseline, 12 weeks and 6 months

Previous secondary outcome measures:

Voices outcomes:
1. Beliefs about Voices Revised BAVQ-R (Chadwicket al., 2000)
2. Voices Acceptance and Actions Scale (Shawyer et al., 2007)
3. Voice power differential scale (Birchwood et al., 2000)

Global:
1. Scales for the Assessment of Positive and Negative Symptoms (SAPS/SANS - Andreasen,1984)
2. Psychotic Symptoms Rating Scale- Delusions (Haddock et al., 1999)
3. Beliefs about problems (Watson et al., 2006)
4. Calgary Depression Scale (Addington et al., 1993)

Quality of life:
1. Manchester Short Assessment of Quality of Life - MANSA (Priebe et al., 1999)
2. EQ5-D (EuroQol, 1999)

Service use:
Client service receipt inventory (Beecham and Knapp, 2001)

Measured at baseline, 8 weeks, 12 weeks and 6 months

Overall trial start date

01/06/2013

Overall trial end date

01/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Male or female, aged 18+ who have experienced persistent auditory hallucinations despite medical treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

142

Participant exclusion criteria

1. Age under 18
2. Primary diagnosis of organic brain disease or substance dependency
3. Auditory hallucinations in a language not spoken by therapists

Recruitment start date

01/06/2013

Recruitment end date

01/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

PO 33 HSPRD
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

c/o Keith Brennan
Director of Research Management
Room 1.8 Hodgkin Building
Guys Campus
King's College London
London
SE1 4UL
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK), FWBC-AVATAR 098272/z/12/z

Alternative name(s)

Wellcome

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26269098
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29175276

Publication citations

Additional files

Editorial Notes

13/12/2017: Internal review. 28/11/2017: Publication reference added. 21/09/2017: Publication and dissemination plan and IPD sharing statement added.