A Pilot Randomized Controlled Study to Compare Avatar Therapy and Cognitive Behavioral Therapy in Patients With Treatment-resistant Schizophrenia.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Auditory Hallucination, Verbal
- Sponsor
- Ciusss de L'Est de l'Île de Montréal
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Change in Psychotic Symptom Rating Scale (PSYRATS) - auditory hallucinations
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Alexandre Dumais
Psychiatrist, Clinical Associate Professor, Principal Investigator
Ciusss de L'Est de l'Île de Montréal
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
Outcomes
Primary Outcomes
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 Outcomes
- Change in Beck Depression Inventory - II (BDI-II)(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)(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(Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months)
- Change in Beliefs About Voices Questionnaire - Revised (BAVQ-R)(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)(Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months)