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Comparaison of Avatar Therapy to Cognitive Behavioral Therapy in Schizophrenia With Treatment Refractory Hallucinations (Phase3)

Primary Purpose

Auditory Hallucination, Verbal, Treatment-resistant Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Avatar Therapy
Cognitive Behavioral Therapy
Sponsored by
Ciusss de L'Est de l'Île de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Auditory Hallucination, Verbal focused on measuring Auditory verbal hallucinations, Schizophrenia, Treatment-resistant, Psychotherapy, Cognitive Behavioral Therapy, Avatar Therapy, Virtual reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de recherche de l'Institut universitaire en santé mentale de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Avatar Therapy

Cognitive Behavioral Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in the Beliefs About Voices Questionnaire - Revised
Beliefs About Voices Questionnaire - Revised: 35-item self-report measure designed to assess key beliefs and responses people have concerning their voice (0-105); Subscales: Malevolence (0-18), Omnipotence (0-18), Benevolence (0-18); higher scores = worse
Change in the Positive And Negative Syndrome Scale
Positive And Negative Syndrome Scale: 30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week; Subscales: Positive (7-49), Negative (7-49), General (16-112), Total score (subscales summed; 30-210); higher values = worse symptomatology
Change in the Calgary Depression Scale for schizophrenia
Calgary Depression Scale for schizophrenia: 9-item semi-structured scale to assess the level of depression in schizophrenia (total score range: 0-27; higher values = worse depressive symptoms)
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form: 16-item self-report scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning (16-80); higher values = better
Change in the Quality of life scale
Quality of life scale: 21-item semi-structured scale measuring quality of life (0-126); higher score = better quality of life
Change in Igroup Presence Questionnaire
Igroup Presence Questionnaire: 14-item scale measuring the sense of presence; higher score = better presence
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; Subscales: Frequency (0-12), Distress (0-20); higher score = worse

Full Information

First Posted
June 19, 2019
Last Updated
November 8, 2022
Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT04054778
Brief Title
Comparaison of Avatar Therapy to Cognitive Behavioral Therapy in Schizophrenia With Treatment Refractory Hallucinations
Acronym
Phase3
Official Title
A Randomized Controlled Trial Comparing Avatar Therapy to Cognitive Behavioral Therapy in Schizophrenia With Treatment Refractory Hallucinations
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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) provide at best moderate results. Using immersive virtual reality, 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 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. The preliminary results of our small pilot randomized-controlled trial showed a large effect of AT on auditory verbal hallucination, while a moderate effect was found for our adapted short CBT for hallucinations. To further research in this field, the primary goal of this single-blinded randomized-controlled, single-site parallel study is to show that AT is superior to CBT for the treatment of persistent auditory hallucinations in schizophrenia. The 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. To do so, each treatment group will include 68 participants over 18 years of age hearing persecutory voices and suffering from treatment resistant schizophrenia or schizoaffective disorder. AT comprises of 9 weekly sessions: 1 avatar creation session and 8 therapeutic sessions, where the patients are confronted to their reproduced hallucinatory experience and are encouraged to enter in a dialogue with their virtual persecutor. CBT includes 9 weekly sessions consisting of learning modules and task assignments. Subjects will be evaluated at pre- and post-treatment. Follow-ups will be ensured at 3, 6 and 12 months to assess primary (auditory hallucination) and secondary outcomes. Mixed model analyses will be performed to measure and compare the effects of both interventions. 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. Ultimately, the demonstration of the superior efficacy of AT would be a great breakthrough and will open new avenues to clinical treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Hallucination, Verbal, Treatment-resistant Schizophrenia
Keywords
Auditory verbal hallucinations, Schizophrenia, Treatment-resistant, Psychotherapy, Cognitive Behavioral Therapy, Avatar Therapy, Virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each participant will be randomized to receive either TA or CBTp.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avatar Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Avatar Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT for psychosis
Intervention Description
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 Information:
Title
Change in the Psychotic Symptom Rating Scale - Auditory Hallucinations
Description
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
Time Frame
Within 1 week after treatment (compared with 1 week before treatment)
Secondary Outcome Measure Information:
Title
Change in the Beliefs About Voices Questionnaire - Revised
Description
Beliefs About Voices Questionnaire - Revised: 35-item self-report measure designed to assess key beliefs and responses people have concerning their voice (0-105); Subscales: Malevolence (0-18), Omnipotence (0-18), Benevolence (0-18); higher scores = worse
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Title
Change in the Positive And Negative Syndrome Scale
Description
Positive And Negative Syndrome Scale: 30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week; Subscales: Positive (7-49), Negative (7-49), General (16-112), Total score (subscales summed; 30-210); higher values = worse symptomatology
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Title
Change in the Calgary Depression Scale for schizophrenia
Description
Calgary Depression Scale for schizophrenia: 9-item semi-structured scale to assess the level of depression in schizophrenia (total score range: 0-27; higher values = worse depressive symptoms)
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Title
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Description
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form: 16-item self-report scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning (16-80); higher values = better
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Title
Change in the Quality of life scale
Description
Quality of life scale: 21-item semi-structured scale measuring quality of life (0-126); higher score = better quality of life
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Title
Change in Igroup Presence Questionnaire
Description
Igroup Presence Questionnaire: 14-item scale measuring the sense of presence; higher score = better presence
Time Frame
During the therapy (at the end of the first and last session of Avatar Therapy)
Title
Change in the Psychotic Symptom Rating Scale - Auditory Hallucinations
Description
Psychotic Symptom Rating Scale - Auditory Hallucinations: 11-item structured interview assessing the severity of auditory hallucinations; Subscales: Frequency (0-12), Distress (0-20); higher score = worse
Time Frame
Follow-ups at 3 months, 6 months and 12 months (compared with 1 week before treatment and with 1 week after treatment))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Dumais, MD, PhD
Phone
514-251-4000
Ext
3925
Email
alexandre.dumais@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane Potvin, PhD
Phone
514-251-4015
Ext
2851
Email
stephane.potvin@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Dumais, MD, PhD
Organizational Affiliation
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche de l'Institut universitaire en santé mentale de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1N3J4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kingsada Phraxayavong, FSA, FICA
Phone
514-251-4000
Ext
3925
Email
kingsada.phraxayavong@gmail.com
First Name & Middle Initial & Last Name & Degree
Alexandre Dumais, MD, PhD
Phone
514-251-4000
Ext
3925
Email
alexandre.dumais@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Alexandre Dumais, MD, PhD
First Name & Middle Initial & Last Name & Degree
Stéphane Potvin, PhD
First Name & Middle Initial & Last Name & Degree
Kieron O'Connor, PhD, FCPA
First Name & Middle Initial & Last Name & Degree
Emmanuel Stipp, MD, MSc
First Name & Middle Initial & Last Name & Degree
Marie-Hélène Goulet, Inf., PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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