Auditory Hallucination, Verbal, Treatment-resistant Schizophrenia
Conditions
Keywords
Auditory verbal hallucinations, Schizophrenia, Treatment-resistant, Psychotherapy, Cognitive Behavioral Therapy, Avatar Therapy, Virtual reality
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALAvatar 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.
Sponsors
Otsuka Canada Pharmaceutical Inc.
Ciusss de L'Est de l'Île de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Psychotic Symptom Rating Scale (PSYRATS) - auditory hallucinations | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 25-item self-reported scale measuring the feeling of empowerment; Range 25-100, Higher values indicate a stronger feeling of empowerment |
| 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 | 21-item self-reported measure assessing depression symptoms over the past 2 weeks; Range 0-63, Higher values indicate more severe depressive symptomatology |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Igroup Presence Questionnaire (IPQ) | 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 |
Countries
Canada
Outcome results
None listed