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Completed

NCT Number: NCT04291586

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

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.

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Key information

Conditions

Psychiatric Disease Mental Disorders

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto das Irmãs Hospitaleiras do Sagrado Coração de Jesus - Casa de Saúde Câmara Pestana

Funchal, Funchal-Madeira, 9060-021, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Virtual Reality

Other

Virtual Reality Intervention of 30 minutes, 3 times a week until reaching 24 sessions.

Paper and Pencil

Other

Paper and Pencil Intervention of 30 minutes, 3 times a week until reaching 24 sessions.

Primary outcomes

  1. Montreal Cognitive Assessment (Cognitive Screening)

    Time frame: Baseline, End (8 weeks) and 8-weeks follow-up

    Change from baseline in the Montreal Cognitive Assessment. Higher values represent better outcomes.

Secondary outcomes

  1. Toulouse-Pieron (Attention)

    Time frame: Baseline, End (8 weeks) and 8-weeks follow-up

    Change from baseline in the Toulouse-Pieron Cancellation Test.

  2. Semantic Fluency and Phonemic Fluency Tests

    Time frame: Baseline, End (8 weeks) and 8-weeks follow-up

    Change from baseline in the Semantic Fluency and Phonemic Fluency Tests

  3. Verbal Paired Associates (WMS-III) (Memory)

    Time frame: Baseline, End (8 weeks) and 8-weeks follow-up

    Change from baseline in the Verbal Paired Associates (WMS-III)

  4. Rey Complex Figure

    Time frame: Baseline, End (8 weeks) and 8-weeks follow-up

    Change from baseline in the Rey Complex Figure

  5. Symbol Search and Coding (WAIS III)

    Time frame: Baseline, End (8 weeks) and 8-weeks follow-up

    Change from baseline in the Symbol Search and Coding (WAIS III)

  6. Rey 15-Item Memory Test

    Time frame: Baseline, End (8 weeks) and 8-weeks follow-up

    Change from baseline in the Rey 15-Item Memory Test

Other outcomes

  1. Beck Depression Inventory - II

    Time frame: Baseline, End (8 weeks) and 8-weeks follow-up

    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.

  2. Barthel Index

    Time frame: Baseline, End (8 weeks) and 8-weeks follow-up

    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.

  3. Katz Index

    Time frame: Baseline, End (8 weeks) and 8-weeks follow-up

    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.

  4. World Health Organization Quality of Life - Bref (WHOQOL-Bref) - Quality of Life Assessment

    Time frame: Baseline, End (8 weeks) and 8-weeks follow-up

    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.

Sponsors and collaborators

Lead sponsor

Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus

Other

Collaborators

  • Universidade da Madeira

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2020
Registry last updated
Jan 6, 2021

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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