Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia

NCT02709733 | Completed

• 1 other identifier: 033-2015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Virtual Reality; Negative Symptoms

Outcome Measures

Primary Outcomes (1)

• Apathy Evaluation Scale (AES)

  9 weeks

Secondary Outcomes (8)

• 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

Study Arms (1)

VR Motivation Training

EXPERIMENTAL

Weekly training sessions with a VR motivation treatment 1 hour per week for 8 weeks.

Behavioral: VR Motivation Training

Interventions

VR Motivation Training BEHAVIORAL

Computerized treatment with a virtual reality-based motivation training program, administered for 1 hour per week for 8 weeks.

VR Motivation Training

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related 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.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• George Foussias, MD PhD FRCPC

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 16, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)