Reducing the frequency and severity of auditory hallucinations: the AVATAR clinical trial

• Register: ISRCTN
• Last refreshed on: 6 June 2022
• Main ID: ISRCTN65314790
• Date of registration: 27/03/2013
• Prospective Registration: Yes
• Primary sponsor: King's College London (UK)
• Public title: Reducing the frequency and severity of auditory hallucinations: the AVATAR clinical trial
• 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
• Date of first enrolment: 01/06/2013
• Target sample size: 142
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN65314790
• Study type: Interventional
• Study design: Single-centre pragmatic two-arm observer-blind randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Thomas Jamieson Craig

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Severe mental illness
Mental and Behavioural Disorders
Mental disorder, not otherwise specified

Intervention(s)

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

Primary Outcome(s)

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(s)

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

Source(s) of Monetary Support

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

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 01/06/2016