Auditory Hallucination, VerbalNCT03585127
Avatar Therapy in Comparison to Cognitive Behavioral Therapy for Treatment-resistant Schizophrenia
A study testing Cognitive Behavioral Therapy and Avatar Therapy in people with Auditory Hallucination, Verbal and Treatment-resistant Schizophrenia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auditory Hallucination, Verbal, Treatment-resistant Schizophrenia
- What is being tested?
- Cognitive Behavioral Therapy and Avatar Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2017to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire en Santé Mentale de Montréal
Montreal, Quebec, H1N 3M5
About this study
Official title: A Pilot Randomized Controlled Study to Compare Avatar Therapy and Cognitive Behavioral Therapy in Patients With Treatment-resistant Schizophrenia.
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.
- Being tested
- Cognitive Behavioral Therapy, Avatar Therapy
- Keywords
- Auditory verbal hallucinations, Schizophrenia, Treatment-resistant, Psychotherapy, Cognitive Behavioral Therapy, Avatar Therapy, Virtual reality
- Medical subject headings
- Hallucinations, Schizophrenia, Treatment-Resistant, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT for psychosis
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.
Avatar TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | Cognitive Behavioral Therapy comprises of nine weekly sessions of an hour. Receives: Behavioral: Cognitive Behavioral Therapy |
| Avatar Therapy | Experimental | Avatar Therapy consists of 9 weekly sessions: one avatar creation session and 8 therapeutic sessions of one hour. Receives: Behavioral: Avatar Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Secondary outcomes (5)
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
Measured: 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)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Mar 2017
- Primary completion31 Mar 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Auditory Hallucination, VerbalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka Canada Pharmaceutical Inc.
- Responsible party
- Principal investigator, Alexandre Dumais, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Alexandre Dumais, MD, Ph.D, Principal investigator, Institut Philippe Pinel de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585127
- Sponsor's protocol ID
- IPPM 16-17 - 06
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2018
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36102593
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Study to Compare Avatar Therapy and Cognitive Behavioral Therapy in Patients With Treatment-resistant Schizophrenia.
- ClinicalTrials.gov ID
- NCT03585127
- Acronym / sponsor ID
- IPPM 16-17 - 06
- Keywords
- Auditory verbal hallucinations, Schizophrenia, Treatment-resistant, Psychotherapy, Cognitive Behavioral Therapy, Avatar Therapy, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Otsuka Canada Pharmaceutical Inc.
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy comprises of nine weekly sessions of an hour. |
| Avatar Therapy | Experimental | Behavioral: Avatar TherapyAvatar Therapy consists of 9 weekly sessions: one avatar creation session and 8 therapeutic sessions of one hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBT for psychosisParticipants 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. | Behavioural | Cognitive Behavioral Therapy |
| Avatar TherapyParticipants 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. | Behavioural | Avatar Therapy |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Derived from this study: PubMed 36102593Hudon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Dumais, MD, Ph.D principal investigator
Institut Philippe Pinel de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Avatar Therapy in people with Auditory Hallucination, Verbal and Treatment-resistant Schizophrenia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03585127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.