Reducing the frequency and severity of auditory hallucinations: the AVATAR clinical trial
| ISRCTN | ISRCTN65314790 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65314790 |
| Secondary identifying numbers | 1 |
- Submission date
- 15/03/2013
- Registration date
- 27/03/2013
- Last edited
- 25/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
PO 33 HSPRD
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
| thomas.craig@kcl.ac.uk |
Study information
| Study design | Single-centre pragmatic two-arm observer-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | AVATAR |
| Study objectives | 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(s) | NRES Committee London - Hampstead, 26/04/2013, REC ref: 13/LO/0482 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2013 |
| Completion date | 01/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 142 |
| Total final enrolment | 150 |
| Key inclusion criteria | Male or female, aged 18+ who have experienced persistent auditory hallucinations despite medical treatment |
| Key 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 |
| Date of first enrolment | 01/06/2013 |
| Date of final enrolment | 01/06/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE5 8AF
United Kingdom
Sponsor information
University/education
c/o Keith Brennan
Director of Research Management
Room 1.8 Hodgkin Building
Guys Campus
King's College London
London
SE1 4UL
England
United Kingdom
| Website | http://www.kcl.ac.uk |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/08/2015 | Yes | No | |
| Results article | results | 01/01/2018 | Yes | No | |
| Other publications | participant experiences | 24/05/2022 | 25/05/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/05/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2018 reference.
13/12/2017: Internal review.
28/11/2017: Publication reference added.
21/09/2017: Publication and dissemination plan and IPD sharing statement added.
