Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
VR Motivation Training
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Virtual Reality, Negative Symptoms
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VR Motivation Training
Arm Description
Weekly training sessions with a VR motivation treatment 1 hour per week for 8 weeks.
Outcomes
Primary Outcome Measures
Apathy Evaluation Scale (AES)
Secondary Outcome Measures
Scale for the Assessment of Negative Symptoms (SANS)
Quality of Life Scale (QLS)
Scale for the Assessment of Positive Symptoms (SAPS)
Brief Assessment of Cognition in Schizophrenia (BACS)
Calgary Depression Scale for Schizophrenia (CDSS)
Simulator Sickness Questionnaire (SSQ)
Functional Brain Imaging
Change in regional brain activity measured with functional MRI
Structural Brain Imaging
Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI
Full Information
NCT ID
NCT02709733
First Posted
March 11, 2016
Last Updated
September 9, 2019
Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Ministry of Health and Long Term Care
1. Study Identification
Unique Protocol Identification Number
NCT02709733
Brief Title
Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia
Official Title
Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Ministry of Health and Long Term Care
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Virtual Reality, Negative Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VR Motivation Training
Arm Type
Experimental
Arm Description
Weekly training sessions with a VR motivation treatment 1 hour per week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
VR Motivation Training
Intervention Description
Computerized treatment with a virtual reality-based motivation training program, administered for 1 hour per week for 8 weeks.
Primary Outcome Measure Information:
Title
Apathy Evaluation Scale (AES)
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Scale for the Assessment of Negative Symptoms (SANS)
Time Frame
9 weeks
Title
Quality of Life Scale (QLS)
Time Frame
9 weeks
Title
Scale for the Assessment of Positive Symptoms (SAPS)
Time Frame
9 weeks
Title
Brief Assessment of Cognition in Schizophrenia (BACS)
Time Frame
9 weeks
Title
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame
9 weeks
Title
Simulator Sickness Questionnaire (SSQ)
Time Frame
9 weeks
Title
Functional Brain Imaging
Description
Change in regional brain activity measured with functional MRI
Time Frame
9 weeks
Title
Structural Brain Imaging
Description
Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Foussias, MD PhD FRCPC
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.camh.ca/en/research
Description
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.
Learn more about this trial
Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia
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