Actively Recruiting
Remotely Delivered Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Auditory Hallucinations: Randomised Controlled Superiority Trial
Led by Swinburne University of Technology · Updated on 2024-11-22
212
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Swinburne University of Technology
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of a new psychological treatment called Avatar Therapy compared to the current standard Cognitive Behavioural Therapy (CBT) for people with psychotic disorders who experience ongoing hearing of voices, known as auditory verbal hallucinations (AVHs). This study aims to find out if Avatar Therapy, which has shown promising results in early trials, is superior to CBT in helping those whose voices persist despite medication. The trial focuses on individuals with schizophrenia-related or mood disorders with psychotic symptoms who have had these hallucinations for at least a year and have not responded well to antipsychotic medications. The study involves two groups receiving therapy remotely via videoconferencing. One group will receive seven 50-minute sessions of CBT that focus on understanding and managing the voices through coping strategies and cognitive restructuring. The other group will receive seven 50-minute sessions of Avatar Therapy, where participants create a visual and audio avatar of their main voice to interact with and practice new ways of responding, combined with broader CBT methods. This innovative approach allows participants to engage directly with a virtual representation of their voices to reduce distress. Participants will be assessed at several points: immediately after the 3-month intervention and at 6 and 9 months follow-up. Researchers will measure the severity of auditory hallucinations, distress related to the voices, remission rates, overall psychosis symptoms, depression, anxiety, and personal recovery using various standardized scales. The study will use structured interviews, questionnaires, and rating scales to monitor progress and outcomes. Participation includes regular videoconference therapy sessions and assessment visits over a period of up to nine months.
CONDITIONS
Brief Title
Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Experiences of Hearing Voices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of schizophrenia-related disorder or mood disorder with psychotic symptoms confirmed by Structured Clinical Interview for DSM (SCID)
- Experiencing current auditory verbal hallucinations with a severity score of 4 or higher on PANSS item P3
- Auditory verbal hallucinations present for at least one year
- Voices include significant negative content (PSYRATS item 6 score 2 or higher) and/or cause distress (PSYRATS item 9 score 2 or higher)
- Current or past treatment with at least two different antipsychotic medications discontinued due to poor response or tolerability
- Access to the internet and a device capable of videoconferencing
- Sufficient English fluency to participate meaningfully
- Age 18 years or older
- Ability to provide informed consent
You will not qualify if you...
- Auditory verbal hallucinations caused by primary substance use or organic disorder
- Estimated IQ below 70 using Test of Premorbid Functioning (TOPF)
- Change in antipsychotic medication within the last month or planned at intake
- Receiving individual psychological therapy for hearing voices or brain stimulation treatment within past 3 months
- Auditory verbal hallucinations in a language not spoken by the therapists
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote or in-person)
Duration - Approximately 3 months
Participants receive seven 50-minute therapy sessions conducted by videoconferencing, either avatar-mediated therapy or cognitive behavioural therapy (CBT).
7 therapy sessions conducted remotely
Duration - 6 months following treatment
Participants are monitored for changes in auditory verbal hallucinations, distress, psychosis symptoms, depression, anxiety, and personal recovery at multiple timepoints after treatment.
Assessments at 3, 6, and 9 months after baseline
Trial Site Locations
Total: 1 location
1
Swinburne University of Technology
Hawthorn, Victoria, Australia, 3122
Actively Recruiting
Research Team
N
Neil Thomas
L
Leila Jameel, PhD, D Clin Psy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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