Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: VR Motivation Training

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 1R8
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR Motivation Training; Weekly training sessions with a VR motivation treatment 1 hour per week for 8 weeks.	Behavioral: VR Motivation Training; Computerized treatment with a virtual reality-based motivation training program, administered for 1 hour per week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Apathy Evaluation Scale (AES)	9 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: Ontario Ministry of Health and Long Term Care
• Investigators: Principal Investigator: George Foussias, MD PhD FRCPC, Centre for Addiction and Mental Health

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Virtual Reality; Negative Symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 033-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO