Clinical trial NCT03585127: Avatar Therapy in Comparison to Cognitive Behavioral Therapy for Treatment-resistant Schizophrenia
Official title: A Pilot Randomized Controlled Study to Compare Avatar Therapy and Cognitive Behavioral Therapy in Patients With Treatment-resistant Schizophrenia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Hallucination, Verbal
Treatment-resistant Schizophrenia
Keywords: Auditory verbal hallucinations
Schizophrenia
Treatment-resistant
Psychotherapy
Cognitive Behavioral Therapy
Avatar Therapy
Virtual reality
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
Collaborators: name: Otsuka Canada Pharmaceutical Inc.
First posted: 2018-07-12
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Psychotic Symptom Rating Scale (PSYRATS) - auditory hallucinations
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Secondary outcomes:
measure: Change in Beliefs About Voices Questionnaire - Revised (BAVQ-R)
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
measure: Change in Positive And Negative Syndrome Scale (PANSS)
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
measure: Change in Beck Depression Inventory - II (BDI-II)
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
measure: Change in Empowerment scale (Making Decisions) - Revised Short Form
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Other outcomes:
measure: Change in Igroup Presence Questionnaire (IPQ)
timeFrame: At the end of each Avatar Therapy session
Locations:
city: Montréal
country: Canada
facility: Institut Universitaire en Santé Mentale de Montréal
state: Quebec
Study officials:
affiliation: Institut Philippe Pinel de Montréal
name: Alexandre Dumais, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.