Recruiting

Avatar Therapy vs. Cognitive Behavioral Therapy

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT04054778

Conditions

Auditory Hallucination, Verbal

Treatment-resistant Schizophrenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Avatar Therapy

Cognitive Behavioral Therapy

Study Details

Brief summary:

Schizophrenia is associated with long-lasting health, social and financial burden for patients, families, caregivers and society. According to the World Health Organization, this burdensome illness is one of the top 10 causes of disability in developed countries. The costs associated with hospitalization, lifelong treatment and loss of productivity lead to a great economic burden. In Canada, the total annual costs associated with schizophrenia are over $10 billion. The main reason for this heavy burden is that 25-30% of schizophrenia patients respond very poorly to antipsychotic medication. Moreover, psychotherapeutic treatment alternatives are very limited for this suffering population. This unmet clinical need requires innovation and action. Psychotherapeutic treatment alternatives such as Cognitive Behavior Therapy (CBT) are very limited and provide at best moderate results. Virtual reality (VR) opens new exciting avenues to treat this illness. With immersive VR, our team recently tested a novel psychotherapeutic intervention, Avatar Therapy (AT), where the therapist engages in a dialogue with the patient through a virtual representation of their distressing voice. This relational and experiential approach offers a unique opportunity to help patients gain control over their voice. The preliminary results of our randomized-controlled trial (RCT) pilot showed a large effect on auditory verbal hallucination for AT and a moderate effect for CBT. The main goal of the currently proposed RCT study will be to examine if AT is superior to CBT for the treatment of chronic auditory hallucinations in schizophrenia. As evidence-based therapeutic options are limited for this burdensome illness and provide only modest symptomatic relief, the current trial will contribute to the validation of a novel approach answering a fundamental clinical need. The demonstration of the superior efficacy of AT would be a great breakthrough and will open new avenues to clinical treatment.

Conditions

Auditory Hallucination, Verbal

Treatment-resistant Schizophrenia

Study ID

NCT04054778

Start date

Apr 1, 2019

Status verified date

Feb, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Apr 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • DSM-5 diagnosis of schizophrenia or schizoaffective disorder
  • Distressing auditory verbal hallucinations
  • Did not respond to 2 antipsychotic trials
  • Stable doses of medication during the last 2 months prior to enrollment

Exclusion Criteria:

  • Substance use disorder within the last 12 months
  • Neurological disorder
  • Intellectual disability
  • Unstable and serious physical illnesses
  • Experiencing an acute psychotic episode
  • Cognitive Behavioral Therapy for psychosis within the last 12 months

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Avatar Therapy

Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist experienced with psychosis patients. The therapy will consist in prompting participants to enter in a dialogue with their persecutor to better regulate their emotional responses. Over the course of the therapy, the avatar's speech and tone will gradually be changed by the therapist to echo participants' improved ability to regulate their emotions. That is, the avatar will progressively change from being abusive to becoming helpful and supportive. By doing so, the therapy will seek to reinforce participants' feeling of empowerment over their voices.

active comparator: Cognitive Behavioral Therapy

Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist trained in Cognitive Behavioral Therapy for psychosis (CBTp). The program is derived and adapted from current evidence-based treatments for hallucinations. The 9 CBTp sessions will consist of a succession of learning modules and suggested task assignments.

Interventions

Avatar Therapy

Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist experienced with psychosis patients. The therapy will consist in prompting participants to enter in a dialogue with their persecutor to better regulate their emotional responses. Over the course of the therapy, the avatar's speech and tone will gradually be changed by the therapist to echo participants' improved ability to regulate their emotions. That is, the avatar will progressively change from being abusive to becoming helpful and supportive. By doing so, the therapy will seek to reinforce participants' feeling of empowerment over their voices.

Cognitive Behavioral Therapy

Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist trained in Cognitive Behavioral Therapy for psychosis (CBTp). The program is derived and adapted from current evidence-based treatments for hallucinations. The 9 CBTp sessions will consist of a succession of learning modules and suggested task assignments.

Primary outcome measure

  • Change in the Psychotic Symptom Rating Scale - Auditory Hallucinations [ Time Frame: Within 1 week after treatment (compared with 1 week before treatment) ]

Central Contacts and Locations

Central contacts

Locations

Centre de recherche de l'Institut universitaire en santé mentale de Montréal

Recruiting

Montréal, Quebec, Canada, H1N3J4

Contacts

Principal Investigator:

Alexandre Dumais, MD, PhD

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Feb 6, 2024

Last verified

Feb, 2024

Keywords

  • Auditory verbal hallucinations
  • Schizophrenia
  • Treatment-resistant
  • Psychotherapy
  • Cognitive Behavioral Therapy
  • Avatar Therapy
  • Virtual reality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2024-02-06.