Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: VR Motivation Training

• Registration Number: NCT02709733
• Lead Sponsor: Centre for Addiction and Mental Health

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-16
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VR Motivation Training	VR Motivation Training	Weekly training sessions with a VR motivation treatment 1 hour per week for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Apathy Evaluation Scale (AES)	9 weeks

Secondary Outcome Measures

Name	Time	Method
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	9 weeks	Change in regional brain activity measured with functional MRI
Structural Brain Imaging	9 weeks	Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada