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OpenTrials
Completed

NCT Number: NCT02709733

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VR Motivation Training

Behavioral

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

Primary outcomes

  1. Apathy Evaluation Scale (AES)

    Time frame: 9 weeks

Secondary outcomes

  1. Scale for the Assessment of Negative Symptoms (SANS)

    Time frame: 9 weeks

  2. Quality of Life Scale (QLS)

    Time frame: 9 weeks

  3. Scale for the Assessment of Positive Symptoms (SAPS)

    Time frame: 9 weeks

  4. Brief Assessment of Cognition in Schizophrenia (BACS)

    Time frame: 9 weeks

  5. Calgary Depression Scale for Schizophrenia (CDSS)

    Time frame: 9 weeks

  6. Simulator Sickness Questionnaire (SSQ)

    Time frame: 9 weeks

  7. Functional Brain Imaging

    Time frame: 9 weeks

    Change in regional brain activity measured with functional MRI

  8. Structural Brain Imaging

    Time frame: 9 weeks

    Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Ontario Ministry of Health and Long Term Care

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2016
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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