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| Name | Class |
|---|---|
| Otsuka Canada Pharmaceutical Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy | Active Comparator | Cognitive Behavioral Therapy comprises of nine weekly sessions of an hour. |
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| Avatar Therapy | Experimental | Avatar Therapy consists of 9 weekly sessions: one avatar creation session and 8 therapeutic sessions of one hour. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Dumais, MD, Ph.D | Institut Philippe Pinel de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire en Santé Mentale de Montréal | Montreal | Quebec | H1N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36102593 | Derived | 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. |
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| ID | Term |
|---|---|
| D006212 | Hallucinations |
| D000090663 | Schizophrenia, Treatment-Resistant |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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. |
|
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |