Comparing the Impact of Virtual Reality and Paper and Pencil on Psychosocial Rehabilitation

Psychiatric Disease Clinical Trial

Official title:

The Impact of Using an Interactive System and a Paper and Pencil Program in Psychosocial Rehabilitation of Psychiatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04291586
• Other study ID #: Casa de Saúde Câmara Pestana
• Status: Completed
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: January 2021
• Source: Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Virtual Reality allows the integration of cognitive rehabilitation in a more ecologically valid context.

The purpose of this study is to determine whether this methodology has more impact on psychosocial rehabilitation than a paper and pencil personalized program.

Description:

Cognitive impairments are frequently present on many psychiatric diseases, such as schizophrenia, depression, etc. and are not always given sufficient attention despite its limitations in activities of daily living (ADL's). Current cognitive rehabilitation methods mostly rely on paper-and-pencil tasks targeting isolated domains, which is not consistent with everyday life, and have limited ecological validity.

Virtual Reality (VR) has shown to be a solution for the development of accessible and ecologically valid systems but, does it have more impact than a paper and pencil personalized intervention?

Through a participatory design approach, with health professionals, the investigators have developed:

a motor-accessible and cognitive-personalized VR-based system, where conventional cognitive tasks were operationalized in meaningful simulations of ADL's (Reh@City) and; a web tool which generates personalized paper and pencil tasks (Task Generator).

The investigators goal is to have a sample of 30 inpatients from a psychosocial rehabilitation unit, with no age limit, randomly allocated in two groups: 1) the experimental group, where participants will perform 30 minutes of the VR training with Reh@City; and 2) the control group, where participants will perform 30 minutes of the paper and pencil training with the Task Generator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 31, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Inpatients of psychosocial rehabilitation unit;

• Cognitive deficit but with enough capacity to understand the task and follow instructions;

• Able to read and write.

Exclusion Criteria:

• Patients experiencing an acute psychiatric episode.

Related Conditions & MeSH terms

• Mental Disorders
• Psychiatric Disease

Intervention

Other:
• Virtual reality
Virtual Reality Intervention of 30 minutes, 3 times a week until reaching 24 sessions.
• Paper and Pencil
Paper and Pencil Intervention of 30 minutes, 3 times a week until reaching 24 sessions.

Locations

Country	Name	City	State
Portugal	Instituto das Irmãs Hospitaleiras do Sagrado Coração de Jesus - Casa de Saúde Câmara Pestana	Funchal	Funchal-Madeira

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus	Universidade da Madeira

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Beck Depression Inventory - II	Change from baseline in the Beck Depression Inventory - II. It is a self-report inventory that aims to measure the severity of depression. Can be scored between 0-63. Minimal depression, 0-11; Mild depression, 12-18; Moderate depression, 19-24; Severe depression, above 25.	Baseline, End (8 weeks) and 8-weeks follow-up
Other	Barthel Index	Change from baseline in the Barthel Index. It's a scale that measures functionality, with features of activities of daily living with the item: bowel control, bladder control, personal hygiene, using the toilet, eating, transferring, walking on a level surface, getting dressed and undressed, going up and down stairs, taking a shower. The maximum score obtainable is 100 points: scores between 91-99, correspond to slight dependence; 61-90, to moderate dependence; 21-60, to serious dependence; and 0-20, to total dependence.	Baseline, End (8 weeks) and 8-weeks follow-up
Other	Katz Index	Change from baseline in the Katz Index. It's a scale that measures functionality, with features of activities of daily living with the item: showering, dressing, using the toilet, sphincter control, mobility and eating. The highest score obtainable is 6, corresponding to independent; scores between 3 and 5, correspond to moderate dependence; and scores below 2, correspond to very dependent.	Baseline, End (8 weeks) and 8-weeks follow-up
Other	World Health Organization Quality of Life - Bref (WHOQOL-Bref) - Quality of Life Assessment	Change from baseline in the WHOQOL-Bref Quality of Life Assessment. This scale is divided in four domains, physical health, social, psychological and environmental. For the physical health we use the questions: 3 (inverse), 4 (inverse),10,15, 16, 17, 18. For the psychological, questions: 5, 6, 7, 11, 19, 26 (inverse). For the social domain, the questions: 20, 21, 22. For the environmental domain, the questions: 8, 9, 12, 13, 14, 23, 24, 25. The main score is obtained through the sum of the four domains and higher scores correspond to higher perceived quality of life.	Baseline, End (8 weeks) and 8-weeks follow-up
Primary	Montreal Cognitive Assessment (Cognitive Screening)	Change from baseline in the Montreal Cognitive Assessment. Higher values represent better outcomes.	Baseline, End (8 weeks) and 8-weeks follow-up
Secondary	Toulouse-Pieron (Attention)	Change from baseline in the Toulouse-Pieron Cancellation Test.	Baseline, End (8 weeks) and 8-weeks follow-up
Secondary	Semantic Fluency and Phonemic Fluency Tests	Change from baseline in the Semantic Fluency and Phonemic Fluency Tests	Baseline, End (8 weeks) and 8-weeks follow-up
Secondary	Verbal Paired Associates (WMS-III) (Memory)	Change from baseline in the Verbal Paired Associates (WMS-III)	Baseline, End (8 weeks) and 8-weeks follow-up
Secondary	Rey Complex Figure	Change from baseline in the Rey Complex Figure	Baseline, End (8 weeks) and 8-weeks follow-up
Secondary	Symbol Search and Coding (WAIS III)	Change from baseline in the Symbol Search and Coding (WAIS III)	Baseline, End (8 weeks) and 8-weeks follow-up
Secondary	Rey 15-Item Memory Test	Change from baseline in the Rey 15-Item Memory Test	Baseline, End (8 weeks) and 8-weeks follow-up