Clinical trial NCT02709733: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Virtual Reality
Negative Symptoms
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2016-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Between 18 and 35 years old;
2. DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder;
3. Outpatients on a stable dose of antipsychotic and other psychotropic medications for the preceding 4 weeks;
4. Minimum Apathy Evaluation Scale (AES) score of 34.

Exclusion Criteria:

1. Diagnosis of other DSM-IV Axis I disorders;
2. History of active substance abuse or dependence in the past 6 months, with the exception of nicotine;
3. History of neurological disease;
4. History of head trauma with loss of consciousness \>30 minutes
5. Presence of significant akathisia (a rating of \>2 on the Barnes Akathisia Rating Scale (BARS) Global item); or
6. Presence of significant extrapyramidal symptoms (a rating of \>2 on \>2 items of the Simpson Angus Rating Scale (SARS))
7. Any MRI contraindications.

Primary outcomes:
measure: Apathy Evaluation Scale (AES)
timeFrame: 9 weeks
Secondary outcomes:
measure: Scale for the Assessment of Negative Symptoms (SANS)
timeFrame: 9 weeks
measure: Quality of Life Scale (QLS)
timeFrame: 9 weeks
measure: Scale for the Assessment of Positive Symptoms (SAPS)
timeFrame: 9 weeks
measure: Brief Assessment of Cognition in Schizophrenia (BACS)
timeFrame: 9 weeks
measure: Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: 9 weeks
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: 9 weeks
measure: Functional Brain Imaging
timeFrame: 9 weeks
measure: Structural Brain Imaging
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: George Foussias, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: