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

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Trial Information

Short Title:

AVATAR2

Long Title:

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

Study website:

https://www.avatartherapytrial.com/

Trial registry:

ISRCTN - ISRCTN55682735: Optimising AVATAR therapy for distressing voices

 

Recruitment Status

Recruitment status: Amber

Target - 75

Actual - 59

Recruitment end date - 30 November 2022

Contact Details

Study Locations:

  1. Throughout NHS Greater Glasgow and Clyde:
  • Glasgow Clinical Research Facilities (Glasgow Royal Infirmary, Queen Elizabeth University Hospital, Gartnavel General Hospital)
  • Inpatient units
  1. University of Glasgow:
  • Glasgow Mental Health Research Facility, Todd Campus, West of Scotland Science Park, Maryhill Road
  1. Remote therapy is also offered

Principal Investigator:

Professor Andrew Gumley – Andrew.gumley@glasgow.ac.uk

AVATAR2 Trial Manager (Glasgow):

Dr Moya Clancy – Moya.Clancy@ggc.scot.nhs.uk

 

Study Overview

This is a three arm randomised controlled trial, comparing a course of extended therapy (12 sessions) to brief therapy (6 sessions) and both to a treatment as usual (TAU) comparison condition. Participants will be randomised 1:1:1 to one of the study arms.

AVATAR Therapy is a computer-assisted treatment of distressing voices in people with experiences of psychosis (e.g. a diagnosis of schizophrenia). It involves a three-way conversation between therapist, patient and a digital image on a computer (‘avatar’) of his/her distressing voice. The therapist, sitting in a different room from the patient, speaks either as him/herself or in a digitally transformed voice as the avatar. The patient sits in front of a computer screen on which the avatar appears. The therapy was originally developed as 8 sessions with two components – an initial phase (1-3 sessions) focused on reducing anxiety when confronting the avatar followed by a second phase (4 -8 sessions) of more complex conversations based on the person’s beliefs about the identity, power and threat of the voices. The technique has been shown to be effective in reducing voice frequency and associated distress when compared to a waiting list control and to supportive counselling. As both phases were delivered to all participants in these studies, it was not possible to understand the effectiveness of each phase separately.

The primary objective is to explore the effectiveness of two levels of therapy compared to TAU in an NHS setting. This will be measured using Psychotic Symptoms Rating Scales at baseline, 16 and 28 weeks. Results from this study will inform how AVATAR therapy is delivered in the future, specifically whether brief therapy can be offered which requires less specialist therapeutic skills for delivery. Further analyses exploring hypothesised mediators and moderators of effects are planned to identify the characteristics of those who will benefit from the full approach and those for whom brief therapy will be sufficient.

The trial is funded by an Innovations Project award from The Wellcome Trust. A total of 345 service users will be recruited (87 per site), with 115 participants per treatment arm.

Eligibility criteria

Inclusion:

  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 spoken in English.
  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 through clinical records and additional consultation with clinical team if unclear.

Exclusion:

  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.

Study visits

Visit 1: Baseline – 2.5 hours

Consent.

Self-report and interview measures involving questions about voice frequency, content and associated distress as well as mood, self-esteem and contact with health services

Therapy Procedures

All participants (in all groups) will continue to receive treatment as usual from their referring clinicians/services. TAU is defined with reference to best practice, specifically NICE guidance on community mental health treatment for people with psychosis and standards of care required by the Care Quality commission. Participation will not alter usual treatment decisions about medication and additional psychological interventions which remain the responsibility of the clinical team

Participants randomised to extended AVATAR therapy will receive a total of 12 weekly therapy sessions (in addition to an initial meeting and avatar set-up) 

Participants randomised to brief AVATAR therapy will receive a total of 6 sessions (in addition to an initial meeting and avatar set up) over 12 weeks.

16 weeks post baseline - 1.5 hours

Self-report and interview measures involving questions about voice frequency, content and associated distress as well as mood, self-esteem and contact with health services

28 weeks post baseline  - 1.5 hours

Self-report and interview measures involving questions about voice frequency, content and associated distress as well as mood, self-esteem and contact with health services

Additional study assessment (optional)

Smartphone application (M-Path), 10 times a day for 6 days. This app can either be downloaded to the participant’s personal mobile phone or to one provided by the trial team with mobile data which is required for completion of the questionnaires

End of study - QUALITATIVE INTERVIEW

Following completion of the study a consecutive sample of participants who give their consent will be recruited to complete a qualitative interview regarding their participation in the study.

Participants will be in study for up to 30 weeks

Patient expenses

All reasonable travel expenses will be reimbursed and participants will receive the following payment dependent on the number of visits completed: 

£20 per meeting with the researcher, up to a total of £60

£20 for completing each research assessment, with an additional £15 if they complete the smartphone assessment (6 days)

Up to a maximum of £105 for the duration of participation (baseline, post-therapy and follow-up).