Avatar Therapy in Comparison to Cognitive Behavioral Therapy for Treatment-resistant Schizophrenia

A Pilot Randomized Controlled Study to Compare Avatar Therapy and Cognitive Behavioral Therapy in Patients With Treatment-resistant Schizophrenia.

Schizophrenia is associated with long-lasting health, social and financial burden for patients, families, caregivers and society. Unfortunately, 25-30% of schizophrenia patients respond 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) provide at best moderate results. Using immersive virtual reality, we recently tested a novel psychotherapeutic intervention, Avatar Therapy (AT), where the therapist engages in a dialogue with the patient through a virtual representation of the patient's distressing voice. This approach, being both relational and experiential, provides a unique opportunity to aid patients gain control over their voice. The results of our pilot study on AT were clinically promising for the severity and distress related to hallucinations, positive symptomatology and emotion regulation. To further research in this field, the primary goal of this randomized-controlled, single-site parallel study is to show that AT is superior to CBT for the treatment of persistent auditory hallucinations in schizophrenia. Our secondary goal is to examine the effects of these interventions on emotion regulation, mood symptoms (anxiety and depression), self-esteem, level of functioning and quality of life.

Study Overview

• Status: Completed
• Conditions: Treatment-resistant Schizophrenia; Auditory Hallucination, Verbal
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Behavioral: Avatar Therapy

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1N 3M5
      • Institut Universitaire en Santé Mentale de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• distressing auditory verbal hallucinations
• medication resistance relating to auditory verbal hallucinations (no response after 3 antipsychotics trials lasting at least 4 weeks each with a minimum of 400mg chlorpromazine equivalent)
• DSM-5 diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

• any change in medication within the past 2 months;
• substance use disorder within the last 12 months
• neurological disorder or unstable and serious physical illness
• ongoing psychotic episode
• Cognitive Behavioral Therapy for psychosis within the last 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Behavioral Therapy; Cognitive Behavioral Therapy comprises of nine weekly sessions of an hour.	Behavioral: 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.; Other Names: CBT for psychosis
Experimental: Avatar Therapy; Avatar Therapy consists of 9 weekly sessions: one avatar creation session and 8 therapeutic sessions of one hour.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Psychotic Symptom Rating Scale (PSYRATS) - auditory hallucinations	11-item structured interview assessing the severity of auditory hallucinations; Range 0-44, Higher values indicate a worse outcome	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Beliefs About Voices Questionnaire - Revised (BAVQ-R)	35-item self-reported measure designed to assess key beliefs and responses people have concerning their voice; Range 0-105, Higher scores indicate more beliefs and responses toward their voice	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Change in Positive And Negative Syndrome Scale (PANSS)	30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week; Range 30-210, Higher values indicate a more severe symptomatology	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Change in Beck Depression Inventory - II (BDI-II)	21-item self-reported measure assessing depression symptoms over the past 2 weeks; Range 0-63, Higher values indicate more severe depressive symptomatology	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)	16-item self-reported scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning; Range 14-70, Higher values indicate a better satisfaction of life	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Change in Empowerment scale (Making Decisions) - Revised Short Form	25-item self-reported scale measuring the feeling of empowerment; Range 25-100, Higher values indicate a stronger feeling of empowerment	Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Igroup Presence Questionnaire (IPQ)	14-item scale measuring the sense of presence; Range 0-84, Higher values indicate a stronger feeling of presence	At the end of each Avatar Therapy session

Collaborators and Investigators

• Sponsor: Ciusss de L'Est de l'Île de Montréal
• Collaborators: Otsuka Canada Pharmaceutical Inc.
• Investigators: Principal Investigator: Alexandre Dumais, MD, Ph.D, Institut Philippe Pinel de Montréal

Publications and helpful links

General Publications

• Hudon A, Leveille N, Sanchez-Schicharew K, Dellazizzo L, Phraxayavong K, Dumais A. The impacts of the COVID-19 pandemic on treatment-resistant schizophrenia patients having followed virtual reality therapy or cognitive behavioural therapy: a content analysis. Ann Med. 2022 Dec;54(1):2477-2485. doi: 10.1080/07853890.2022.2121852.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Schizophrenia; Cognitive Behavioral Therapy; Virtual reality; Psychotherapy; Auditory verbal hallucinations; Treatment-resistant; Avatar Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Schizophrenia; Hallucinations
• Other Study ID Numbers: IPPM 16-17 - 06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No