Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709733
• Other study ID #: 033-2015
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2018

Study information

• Verified date: September 2019
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• VR Motivation Training
Computerized treatment with a virtual reality-based motivation training program, administered for 1 hour per week for 8 weeks.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apathy Evaluation Scale (AES)		9 weeks
Secondary	Scale for the Assessment of Negative Symptoms (SANS)		9 weeks
Secondary	Quality of Life Scale (QLS)		9 weeks
Secondary	Scale for the Assessment of Positive Symptoms (SAPS)		9 weeks
Secondary	Brief Assessment of Cognition in Schizophrenia (BACS)		9 weeks
Secondary	Calgary Depression Scale for Schizophrenia (CDSS)		9 weeks
Secondary	Simulator Sickness Questionnaire (SSQ)		9 weeks
Secondary	Functional Brain Imaging	Change in regional brain activity measured with functional MRI	9 weeks
Secondary	Structural Brain Imaging	Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI	9 weeks

External Links

•   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.