SchizophreniaNCT02709733
Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia
A study testing VR Motivation Training in people with Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The loss of motivation has emerged as a critical symptom in schizophrenia that is consistently linked to functional disability for affected individuals. Despite advances in treatment, there have not emerged any effective treatments for this loss of motivation, which ultimately hinders our ability to promote recovery… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- VR Motivation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Aug 2018
- 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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 and 35 years old;
- DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder;
- Outpatients on a stable dose of antipsychotic and other psychotropic medications for the preceding 4 weeks;
- Minimum Apathy Evaluation Scale (AES) score of 34.
Who cannot join
- Diagnosis of other DSM-IV Axis I disorders;
- History of active substance abuse or dependence in the past 6 months, with the exception of nicotine;
- History of neurological disease;
- History of head trauma with loss of consciousness >30 minutes
- Presence of significant akathisia (a rating of >2 on the Barnes Akathisia Rating Scale (BARS) Global item); or
- Presence of significant extrapyramidal symptoms (a rating of >2 on >2 items of the Simpson Angus Rating Scale (SARS))
- Any MRI contraindications.
Trial locations and contacts
1 site in 1 country.
About this study
The loss of motivation has emerged as a critical symptom in schizophrenia that is consistently linked to functional disability for affected individuals. Despite advances in treatment, there have not emerged any effective treatments for this loss of motivation, which ultimately hinders our ability to promote recovery for individuals with schizophrenia. To address this critical unmet therapeutic need, this study aims to investigate a novel computerized motivation rehabilitation program using virtual reality to treat motivation loss in schizophrenia.
Read the detailed description
Motivational deficits have emerged as a critical determinant of functional disability in schizophrenia (SZ). Despite significant advances in our understanding and treatment of the illness, effective therapeutic strategies for motivational deficits have remained elusive. This has ultimately hindered our ability to promote recovery for individuals with SZ so that they can return to their premorbid level of functioning. An emerging therapeutic approach in SZ has utilized computerized remediation strategies, with recent efforts focused on cognitive deficits. To date, however, such a therapeutic strategy has not been developed for the critical motivational deficits in SZ. In light of the detrimental functional consequences of motivational deficits in SZ, there is a clear need for effective therapeutic strategies for the treatment of these motivational deficits experienced by affected individuals. To address this unmet therapeutic need, this pilot therapeutic trial will investigate the efficacy of a novel virtual reality-based motivation rehabilitation program in schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- VR Motivation Training
- Keywords
- Virtual Reality, Negative Symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Motivation TrainingBehavioural
Computerized treatment with a virtual reality-based motivation training program, administered for 1 hour per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| VR Motivation Training | Experimental | Weekly training sessions with a VR motivation treatment 1 hour per week for 8 weeks. Receives: Behavioral: VR Motivation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apathy Evaluation Scale (AES)
Measured: 9 weeks
Secondary outcomes (8)
Scale for the Assessment of Negative Symptoms (SANS)
Measured: 9 weeks
Quality of Life Scale (QLS)
Measured: 9 weeks
Scale for the Assessment of Positive Symptoms (SAPS)
Measured: 9 weeks
Brief Assessment of Cognition in Schizophrenia (BACS)
Measured: 9 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
Measured: 9 weeks
Simulator Sickness Questionnaire (SSQ)
Measured: 9 weeks
Functional Brain Imaging
Change in regional brain activity measured with functional MRI
Measured: 9 weeks
Structural Brain Imaging
Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, George Foussias, Centre for Addiction and Mental Health
- Investigators
- George Foussias, MD PhD FRCPC, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709733
- Sponsor's protocol ID
- 033-2015
- Status last verified
- Sep 2019
- First submitted
- 11 Mar 2016
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia
- ClinicalTrials.gov ID
- NCT02709733
- Acronym / sponsor ID
- 033-2015
- Conditions
- Schizophrenia
- Keywords
- Virtual Reality, Negative Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 16 Mar 2016 (estimated)
- 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.
The loss of motivation has emerged as a critical symptom in schizophrenia that is consistently linked to functional disability for affected individuals. Despite advances in treatment, there have not emerged any effective treatments for this loss of motivation, which ultimately hinders our ability to promote recovery for individuals with schizophrenia. To address this critical unmet therapeutic need, this study aims to investigate a novel computerized motivation rehabilitation program using virtual reality to treat motivation loss in schizophrenia.
Detailed description
Motivational deficits have emerged as a critical determinant of functional disability in schizophrenia (SZ). Despite significant advances in our understanding and treatment of the illness, effective therapeutic strategies for motivational deficits have remained elusive. This has ultimately hindered our ability to promote recovery for individuals with SZ so that they can return to their premorbid level of functioning. An emerging therapeutic approach in SZ has utilized computerized remediation strategies, with recent efforts focused on cognitive deficits. To date, however, such a therapeutic strategy has not been developed for the critical motivational deficits in SZ. In light of the detrimental functional consequences of motivational deficits in SZ, there is a clear need for effective therapeutic strategies for the treatment of these motivational deficits experienced by affected individuals. To address this unmet therapeutic need, this pilot therapeutic trial will investigate the efficacy of a novel virtual reality-based motivation rehabilitation program in schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR Motivation Training | Experimental | Behavioral: VR Motivation TrainingWeekly training sessions with a VR motivation treatment 1 hour per week for 8 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18 and 35 years old;
- DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder;
- Outpatients on a stable dose of antipsychotic and other psychotropic medications for the preceding 4 weeks;
- Minimum Apathy Evaluation Scale (AES) score of 34.
Key exclusion criteria (7 listed)
- Diagnosis of other DSM-IV Axis I disorders;
- History of active substance abuse or dependence in the past 6 months, with the exception of nicotine;
- History of neurological disease;
- History of head trauma with loss of consciousness >30 minutes
- Presence of significant akathisia (a rating of >2 on the Barnes Akathisia Rating Scale (BARS) Global item); or
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 |
|---|---|---|
| VR Motivation TrainingComputerized treatment with a virtual reality-based motivation training program, administered for 1 hour per week for 8 weeks. | Behavioural | VR Motivation Training |
Primary outcome
Apathy Evaluation Scale (AES)
Time frame: 9 weeks
8 secondary outcomes
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: 9 weeks
Quality of Life Scale (QLS)
Time frame: 9 weeks
Scale for the Assessment of Positive Symptoms (SAPS)
Time frame: 9 weeks
Brief Assessment of Cognition in Schizophrenia (BACS)
Time frame: 9 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: 9 weeks
Simulator Sickness Questionnaire (SSQ)
Time frame: 9 weeks
Functional Brain Imaging
Time frame: 9 weeks
Structural Brain Imaging
Time frame: 9 weeks
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 11 Sep 2019.
- The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.Link provided by the sponsor.
- 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.
George Foussias, MD PhD FRCPC principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Motivation Training in people with Schizophrenia, run by Centre for Addiction and Mental Health 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 4 inclusion and 7 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 11 Sep 2019. 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?
Apathy Evaluation Scale (AES) (time frame: 9 weeks). 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 11 Sep 2019.