Comparaison of Avatar Therapy to Cognitive Behavioral Therapy in Schizophrenia With Treatment Refractory Hallucinations

NCT04054778 | Recruiting DMC

• 1 other identifier: MP-12-2019-1726
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in the Psychotic Symptom Rating Scale - Auditory Hallucinations

  Psychotic Symptom Rating Scale - Auditory Hallucinations: 11-item structured interview assessing the severity of auditory hallucinations (scale 0-44); Subscales: Frequency (0-12), Distress (0-20); higher values = worse

  Within 1 week after treatment (compared with 1 week before treatment)

Secondary Outcomes (7)

• Change in the Beliefs About Voices Questionnaire - Revised

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

• Change in the Positive And Negative Syndrome Scale

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

• Change in the Calgary Depression Scale for schizophrenia

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

• Change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

• Change in the Quality of life scale

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

Study Arms (2)

Avatar Therapy

EXPERIMENTAL

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.

Behavioral: Avatar Therapy

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Behavioral Therapy

Interventions

Avatar Therapy BEHAVIORAL

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.

Avatar Therapy

Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: CBT for psychosis

Cognitive Behavioral Therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

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

Montreal, Quebec, H1N3J4, Canada

RECRUITING

MeSH Terms

Conditions

Hallucinations; Schizophrenia, Treatment-Resistant; 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

• Alexandre Dumais, MD, PhD

  Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Dumais, MD, PhD

CONTACT

514-251-4000; alexandre.dumais@umontreal.ca

Stéphane Potvin, PhD

CONTACT

514-251-4015; stephane.potvin@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The therapists, the study coordinator and the participants will be aware of the interventions after the allocation randomization. The principal investigators and independent evaluators will be blind to the random allocation conditions. The evaluators will be separated from the therapists by working at a separate location on the hospital grounds and will sign agreements not to discuss cases with any other team member. Management of the evaluations will be delegated to a coordinator preventing any direct contact between the investigators and the independent evaluators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, Clinical Associate Professor, Principal Investigator

Model Details: Each participant will be randomized to receive either TA or CBTp.

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: August 13, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)