Ecologically Valid Virtual Tasks vs Paper-pencil Methods in Cognitive Rehabilitation in Patients With Schizophrenia and Depression

Sponsor

National Institute of Mental Health, Czech Republic (Other)

Overall Status

Completed

CT.gov ID

NCT04598906

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Schizophrenia is heterogeneous and often disabling a disease that affects 1% of the population. Current psychopharmacological treatment significantly eliminates the presence of positive symptoms (especially delusions and hallucinations) and partly also negative symptoms (social withdrawal or abulia). In contrast, the cognitive deficits associated both with schizophrenia and depression are only limitedly influenced by pharmacological treatment.The cognitive impairment represents an important part of schizophrenia symptomatology and it has a severe negative impact on patients' quality of life. In depression is the impairment milder but still significantly contributes to patients' daily functioning. The profound deficit was repeatedly documented in the area of declarative and working memory. In this study, we study the effectiveness of virtual environment rehabilitation program focused on declarative memory, working memory and attention in comparison to standard paper-pencil rehabilitation led by an occupational therapist.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Depression Cognitive Impairment	Behavioral: Virtual environment rehabilitation Behavioral: Paper-pencil rehabilitation	N/A

Detailed Description

This study compares effectiveness of the virtual environment cognitive rehabilitation program with standard paper-pencil approach in within-subject design.

Participants with a diagnosis of schizophrenia, schizoaffective disorder or major depressive disorder will undergo a baseline assessment of cognition.

The participants will be at the baseline randomly assigned to each condition: virtual environment rehabilitation or paper-pencil rehabilitation. Then they will participate in 10-15 sessions (30-45 minutes) once or twice a week.

All participants will undergo retest assessment of cognition.

After completion of the first program the participants will be assigned to the different condition: to paper-pencil or virtual environment rehabilitation. After 10-15 sessions in the second condition the participants will once more undergo retest assessment of cognition.

Within-subject design is an effective tool in the development of scientifically proven treatment tools. This approach allows to obtain reliable information about the effectiveness of the method and to examine the influences of other variables (Steingrimsdottir and Arntzen 2015). This study will allow to get credible information on the importance of using the virtual environment in the context of cognitive rehabilitation in patients with schizophrenia and depression.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of the Effectiveness of the Virtual Environment in Cognitive Rehabilitation With Standard Rehabilitation Methods in Patients With Schizophrenia and in Patients With Major Depressive Disorder

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual environment rehabilitation - Paper-pencil rehabilitation The participants in this arm completes Virtual environment rehabilitation as the first condition and then crossover to Paper-pencil rehabilitation.	Behavioral: Virtual environment rehabilitation The participants attended 10-15 computer sessions during 6-12 weeks. Each session lasted 30 minutes and consisted of the set of virtual environment tasks (Shooting Range,Virtual Supermarket Shopping Task and Objects). Shooting range demands differentiation of targets from non-targets and focuses on training of selective attention, psychomotor speed and inhibition control. Virtual Supermarket Shopping requires memorizing the shopping list and searching for products in the supermarket area. Objects requires memorizing of the spatial and temporal context while searching for objects. Behavioral: Paper-pencil rehabilitation The participants in the paper-pencil rehabilitation attended 10-15 paper pencil sessions for 6-12 weeks. Each session lasted 45 minutes. Each paper-pencil session starts with a warm-up game. The session continues with a set of paper-pencil tasks focused on attention, fine motor skills, recall, short-term and long-term memory, verbal fluency, visual search, cognitive flexibility, abstraction and executive functions, numerical abilities. The tasks are adapted according to the participant´s abilities.
Experimental: Paper-pencil rehabilitation - Virtual environment rehabilitation The participants in this arm completes Paper-pencil rehabilitation as the first condition and then crossover to Virtual environment rehabilitation.	Behavioral: Virtual environment rehabilitation The participants attended 10-15 computer sessions during 6-12 weeks. Each session lasted 30 minutes and consisted of the set of virtual environment tasks (Shooting Range,Virtual Supermarket Shopping Task and Objects). Shooting range demands differentiation of targets from non-targets and focuses on training of selective attention, psychomotor speed and inhibition control. Virtual Supermarket Shopping requires memorizing the shopping list and searching for products in the supermarket area. Objects requires memorizing of the spatial and temporal context while searching for objects. Behavioral: Paper-pencil rehabilitation The participants in the paper-pencil rehabilitation attended 10-15 paper pencil sessions for 6-12 weeks. Each session lasted 45 minutes. Each paper-pencil session starts with a warm-up game. The session continues with a set of paper-pencil tasks focused on attention, fine motor skills, recall, short-term and long-term memory, verbal fluency, visual search, cognitive flexibility, abstraction and executive functions, numerical abilities. The tasks are adapted according to the participant´s abilities.

Arm

Intervention/Treatment

Experimental: Virtual environment rehabilitation - Paper-pencil rehabilitation

The participants in this arm completes Virtual environment rehabilitation as the first condition and then crossover to Paper-pencil rehabilitation.

Behavioral: Virtual environment rehabilitation

The participants attended 10-15 computer sessions during 6-12 weeks. Each session lasted 30 minutes and consisted of the set of virtual environment tasks (Shooting Range,Virtual Supermarket Shopping Task and Objects). Shooting range demands differentiation of targets from non-targets and focuses on training of selective attention, psychomotor speed and inhibition control. Virtual Supermarket Shopping requires memorizing the shopping list and searching for products in the supermarket area. Objects requires memorizing of the spatial and temporal context while searching for objects.

Behavioral: Paper-pencil rehabilitation

The participants in the paper-pencil rehabilitation attended 10-15 paper pencil sessions for 6-12 weeks. Each session lasted 45 minutes. Each paper-pencil session starts with a warm-up game. The session continues with a set of paper-pencil tasks focused on attention, fine motor skills, recall, short-term and long-term memory, verbal fluency, visual search, cognitive flexibility, abstraction and executive functions, numerical abilities. The tasks are adapted according to the participant´s abilities.

Experimental: Paper-pencil rehabilitation - Virtual environment rehabilitation

The participants in this arm completes Paper-pencil rehabilitation as the first condition and then crossover to Virtual environment rehabilitation.

Behavioral: Virtual environment rehabilitation

Behavioral: Paper-pencil rehabilitation

Outcome Measures

Primary Outcome Measures

Cognitive abilities measured by The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Baseline, 6-12 weeks, 12-24 weeks]

Secondary Outcome Measures

Item performance in Virtual Supermarket Shopping Task [Baseline, 6-12 weeks]
The data from individual sessions with Virtual Supermarket Shopping Task will be analyzed to see participants' progress. The variable item performance will be used = number of items to remember/ correctly collected items.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of schizophrenia and other primary psychotic disorders or diagnosis of major depressive disorder according to International Classification of Diseases-11

Exclusion Criteria:

Severe visual impairment
Age over 60 years
Diagnosis of other psychiatric disorder than schizophrenia or major depressive disorder
Physical handicap preventing the participant from participating in virtual environment training
Refusal to sign an informed consent