Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Experiences of Hearing Voices

NCT05982158 | Recruiting DMC

• 1 other identifier: GNT2015133
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of a new psychological therapy, Avatar Therapy, to the current standard therapy, Cognitive Behavioural Therapy (CBT), in improving outcomes in people living with psychotic disorders who have persisting experiences of hearing voices (auditory verbal hallucinations, AVHs).

Conditions

Auditory Hallucination; Psychotic Disorders; Schizophrenia and Related Disorders

Keywords

Auditory verbal hallucinations; Psychosis; Schizophrenia; Psychological therapy; Cognitive behavior therapy; Avatar therapy; Virtual reality; Telehealth

Outcome Measures

Primary Outcomes (1)

• Auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS)

  Clinician-rated scale providing an index of overall severity based on 11 aspects of hallucinations (frequency, duration, intensity of distress, etc.), rated masked to treatment allocation. Each of the 11-items are scored on a 5-point scale (0 - 4), scores range from 0 to 44, with increased symptom expression indicated by higher scores.

  Immediately post intervention (3 months), controlling for baseline

Secondary Outcomes (7)

• Change in auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) over follow-ups

  Baseline, follow-ups (6 and 9 months)

• Change in auditory verbal hallucination-related distress, measured by the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) Distress Score

  Baseline, immediately post intervention (3 months), and follow-ups (6 and 9 months)

• Remission of hallucinations, indexed by a score below 3 on the Hallucination scale of the Positive and Negative Syndrome Scales (PANSS)

  Immediately post intervention (3 months), follow-ups (6 and 9 months)

• Change in overall psychosis symptom severity, measured by Positive and Negative Syndrome Scales (PANSS) total and sub scale scores

  Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)

• Change in depressive symptoms, measured by the Calgary Depression Scale for Schizophrenia (CDSS)

  Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)

Other Outcomes (12)

• Satisfaction with therapy, measured by the Client Satisfaction Questionnaire (CSQ-8)

  Immediatedly post-intervention (3 months)

• Adverse effects of therapy

  Immediately post-intervention (3 months)

• Cost-effectiveness

  Immediately post intervention (3 months), follow-ups (6 and 9 months)

Study Arms (2)

Cognitive Behavioural Therapy (CBT)

ACTIVE COMPARATOR

The standard therapy arm will be based on a focused cognitive behavioural therapy (CBT) protocol for AVHs. Sessions will involve discussing the characteristics of participant's AVHs, before applying core CBT approaches, adapted to the AVH experience, to conduct a thorough cognitive behavioural assessment with a focus on coping strategy enhancement and cognitive restructuring.

Behavioral: Cognitive behavioural therapy (CBT)

Avatar Therapy

EXPERIMENTAL

The experimental arm will use avatar therapy. Sessions will involve generating an audio-visual avatar as a virtual representation of the primary 'voice' that the participant hears. This will be used to recreate AVHs experientially and allow participants to practice alternative ways of responding to the 'voice'. This innovative approach will be combined with the use of broader CBT methods.

Behavioral: Avatar therapy

Interventions

Avatar therapy BEHAVIORAL

Seven 50-minute therapy sessions conducted by videoconferencing.

Avatar Therapy

Cognitive behavioural therapy (CBT) BEHAVIORAL

Seven 50-minute therapy sessions conducted by videoconferencing.

Cognitive Behavioural Therapy (CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Schizophrenia-related disorder or a mood disorder with psychotic symptoms diagnosis confirmed using the Structured Clinical Interview for DSM (SCID)
• Experiencing current auditory verbal hallucinations as measured by the Positive and Negative Syndrome Scale (PANSS) item P3 ≥ 4
• Auditory verbal hallucinations present for at least one year
• AVHs include significant negative content (PSYRATS item 6 ≥ 2) and/or AVHs are distressing (PSYRATS item item 9 ≥ 2)
• Current treatment with antipsychotic medication, or has been treated with antipsychotic medication in the past, with at least two different antipsychotic compounds, and these have been discontinued due to insufficient treatment response and/or poor tolerability.
• Access to the internet and a computer or other device on which videoconferencing software can be used
• Sufficient fluency in English for meaningful participation
• Age 18 or over
• Ability to give informed consent

You may not qualify if:

• Auditory verbal hallucinations attributable to a primary substance use disorder or organic disorder
• Estimated full scale IQ \< 70 (using the Test of Premorbid Functioning, TOPF)
• Within the last month or planned at the time of intake: a change of antipsychotic medication,
• Current or within the past 3 months receipt of individual psychological therapy for hearing voices, or receipt of electro-convulsive therapy or other brain stimulation treatment;
• AVHs in a language not spoken by the therapists.

Sponsors & Collaborators

• Swinburne University of Technology: lead
• University of Copenhagen: collaborator
• University of Manchester: collaborator
• University of Melbourne: collaborator
• Monash University: collaborator
• Perth Voices Clinic: collaborator
• University of the Sunshine Coast: collaborator
• University of Toronto: collaborator

Study Sites (1)

Swinburne University of Technology

Hawthorn, Victoria, 3122, Australia

RECRUITING

MeSH Terms

Conditions

Hallucinations; Psychotic Disorders; Schizophrenia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Neil Thomas

  Swinburne University of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Thomas

CONTACT

+61 3 92148742; neilthomas@swin.edu.au

Leila Jameel, PhD, D Clin Psy

CONTACT

+61 03 9214 4365; ljameel@swin.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors involved in completing the assessments will be masked to treatment condition. Due to the type of intervention, it will not be possible to blind therapists delivering the interventions to participant's treatment condition. Clinicians providing routine care will also be aware of the condition. Participants will be instructed not to discuss treatment with their outcomes assessor. When an interview leads to unblinding, the outcomes assessor will be replaced.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: AMETHYST is a pragmatic, parallel group, randomised controlled superiority trial, comparing avatar therapy to CBT for persisting AVHs, with the primary outcome of post-intervention hallucination severity. In both arms, therapy will be delivered within a three-month period, with assessor-blinded assessments completed at baseline, post-intervention (3 months), and follow-ups (6 months and 9 months).

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 8, 2023
• Study Start: August 8, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)