Auditory Hallucination, VerbalNCT03148639
Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia
A study testing Avatar therapy and Treatment-as-usual 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
Treatment of verbal hallucinations in schizophrenia is clinically challenging for both the patient and the therapist. For the therapist, one of the main difficulties arises from the impossibility of directly communicating with the entity persecuting the patient. 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?
- Avatar therapy and Treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2015to 2 Dec 2017
- 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 behavioural 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: Emotion Regulation Using Virtual Reality in Schizophrenia: a Clinical and Mechanistic Trial of Avatar Therapy for Refractory Auditory Hallucinations
Treatment of verbal hallucinations in schizophrenia is clinically challenging for both the patient and the therapist. For the therapist, one of the main difficulties arises from the impossibility of directly communicating with the entity persecuting the patient. For the patient, the therapeutic process is challenging because it aims at getting to better cope with an entity that keeps repeating stereotyped and abusive sentences without having the emotional strength to reply to the persecutor. To help overcome these clinical challenges, virtual reality enable patients to recreate the face and the voice of their persecutor.The hypothesis is that the engagement of patients in a dialogue with an external representation of their persecutor, with the support of the therapist, would help them to gain better control over their voices.
- Being tested
- Avatar therapy, Treatment-as-usual
- Keywords
- auditory hallucination, schizophrenia, treatment-resistant, psychotherapy, virtual reality, avatar
- 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.
Avatar therapyBehavioural
Patients will receive 6 sessions of avatar therapy consisting of 45 minute (1 session per week). The therapy will consist in prompting patients to enter in a dialogue with their persecutor to better regulate their emotional responses. Over the course of the therapy, the character of the avatar will progressively become under patients' control. More precisely, the avatar's speech and tone will gradually be changed by the therapist to echo patients' 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 patients' feeling of empowerment over their voices.
Treatment-as-usualOther
Treatment as usual will consist of typical or atypical antipsychotic medication and regulars appointments with psychiatrists and others care team members for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Avatar therapy | Experimental | Immediate Avatar therapy. Receives: Behavioral: Avatar therapy |
| Treatment-as-usual | Other | Treatment-as-usual then delayed Avatar therapy. Receives: Behavioral: Avatar therapy; Other: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychotic Symptom Rating Scale - auditory hallucinations
11-item structured interview assessing the severity of auditory hallucinations
Measured: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Secondary outcomes (4)
Change in Beliefs About Voices Questionnaire - Revised
35-item self-report measure designed to assess key beliefs and responses people have concerning their voice
Measured: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Change in Positive And Negative Syndrome Scale
30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week
Measured: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Change in Beck Depression Inventory - II
21-item self-report measure assessing depression symptoms over the past 2 weeks
Measured: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short From
16-item self-report scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning
Measured: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Sep 2015
- Primary completion31 Mar 2017
- Study completion2 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Model description
- Partial crossover design
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
- 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
- NCT03148639
- Sponsor's protocol ID
- IPPM 14-006
- Status last verified
- Jan 2018
- First submitted
- 5 May 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Using Virtual Reality in Schizophrenia: a Clinical and Mechanistic Trial of Avatar Therapy for Refractory Auditory Hallucinations
- ClinicalTrials.gov ID
- NCT03148639
- Acronym / sponsor ID
- IPPM 14-006
- Keywords
- auditory hallucination, schizophrenia, treatment-resistant, psychotherapy, virtual reality, avatar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 2 Dec 2017 (actual)
- First posted
- 11 May 2017 (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.
Treatment of verbal hallucinations in schizophrenia is clinically challenging for both the patient and the therapist. For the therapist, one of the main difficulties arises from the impossibility of directly communicating with the entity persecuting the patient. For the patient, the therapeutic process is challenging because it aims at getting to better cope with an entity that keeps repeating stereotyped and abusive sentences without having the emotional strength to reply to the persecutor. To help overcome these clinical challenges, virtual reality enable patients to recreate the face and the voice of their persecutor.The hypothesis is that the engagement of patients in a dialogue with an external representation of their persecutor, with the support of the therapist, would help them to gain better control over their voices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Partial crossover design
| Arm | Type | Receives |
|---|---|---|
| Avatar therapy | Experimental | Behavioral: Avatar therapyImmediate Avatar therapy. |
| Treatment-as-usual | Other | Behavioral: Avatar therapy, Other: Treatment-as-usualTreatment-as-usual then delayed Avatar therapy. |
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 behavioural 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 |
|---|---|---|
| Avatar therapyPatients will receive 6 sessions of avatar therapy consisting of 45 minute (1 session per week). The therapy will consist in prompting patients to enter in a dialogue with their persecutor to better regulate their emotional responses. Over the course of the therapy, the character of the avatar will progressively become under patients' control. More precisely, the avatar's speech and tone will gradually be changed by the therapist to echo patients' 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 patients' feeling of empowerment over their voices. | Behavioural | Avatar therapy, Treatment-as-usual |
| Treatment-as-usualTreatment as usual will consist of typical or atypical antipsychotic medication and regulars appointments with psychiatrists and others care team members for a period of 6 weeks. | Other | Treatment-as-usual |
Primary outcome
Change in Psychotic Symptom Rating Scale - auditory hallucinations
Time frame: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
11-item structured interview assessing the severity of auditory hallucinations
4 secondary outcomes
Change in Beliefs About Voices Questionnaire - Revised
Time frame: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Change in Positive And Negative Syndrome Scale
Time frame: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Change in Beck Depression Inventory - II
Time frame: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short From
Time frame: Within 1 week before treatment, within 1 week after treatment, follow-up 3 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 30 Jan 2018.
- 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 Avatar therapy and Treatment-as-usual 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 30 Jan 2018. 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 - auditory hallucinations (time frame: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2018.