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

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ClinicalTrials.gov Identifier: NCT03585127
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Otsuka Canada Pharmaceutical Inc.
Information provided by (Responsible Party):
Alexandre Dumais, Ciusss de L'Est de l'Île de Montréal

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Auditory Hallucination, Verbal Treatment-resistant Schizophrenia Behavioral: Cognitive Behavioral Therapy Behavioral: Avatar Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Study to Compare Avatar Therapy and Cognitive Behavioral Therapy in Patients With Treatment-resistant Schizophrenia.
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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 Name: 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.




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


Secondary Outcome Measures :
  1. Change in Beliefs About Voices Questionnaire - Revised (BAVQ-R) [ Time Frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months ]
    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

  2. Change in Positive And Negative Syndrome Scale (PANSS) [ Time Frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months ]
    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

  3. Change in Beck Depression Inventory - II (BDI-II) [ Time Frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months ]
    21-item self-reported measure assessing depression symptoms over the past 2 weeks; Range 0-63, Higher values indicate more severe depressive symptomatology

  4. Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) [ Time Frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months ]
    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

  5. Change in Empowerment scale (Making Decisions) - Revised Short Form [ Time Frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months ]
    25-item self-reported scale measuring the feeling of empowerment; Range 25-100, Higher values indicate a stronger feeling of empowerment


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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585127


Contacts
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Contact: Alexandre Dumais, MD, PhD 514-730-8377 alexandre.dumais@umontreal.ca
Contact: Stéphane Potvin, Ph.D 514-251-4015 ext 2851 stephane.potvin@umontreal.ca

Locations
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Canada, Quebec
Institut Universitaire en Santé Mentale de Montréal Recruiting
Montréal, Quebec, Canada, H1N 3M5
Contact: Alexandre Dumais, M.D, Ph.D    514-730-8377    alexandre.dumais@umontreal.ca   
Contact: Stéphane Potvin, Ph.D    514-251-4015 ext 2851    stephane.potvin@umontreal.ca   
Sponsors and Collaborators
Ciusss de L'Est de l'Île de Montréal
Otsuka Canada Pharmaceutical Inc.
Investigators
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Principal Investigator: Alexandre Dumais, MD, Ph.D Institut Philippe Pinel de Montréal

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Responsible Party: Alexandre Dumais, Psychiatrist, Clinical Associate Professor, Principal Investigator, Ciusss de L'Est de l'Île de Montréal
ClinicalTrials.gov Identifier: NCT03585127     History of Changes
Other Study ID Numbers: IPPM 16-17 - 06
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexandre Dumais, Ciusss de L'Est de l'Île de Montréal:
Auditory verbal hallucinations
Schizophrenia
Treatment-resistant
Psychotherapy
Cognitive Behavioral Therapy
Avatar Therapy
Virtual reality

Additional relevant MeSH terms:
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Schizophrenia
Hallucinations
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms