Ecologically Valid Virtual Tasks vs Paper-pencil Methods in Cognitive Rehabilitation in Patients With Schizophrenia and Depression
Condition: Schizophrenia; Depression; Cognitive Impairment
MeSH terms: Depression; Depressive Disorder; Schizophrenia
Study type: Interventional

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.
    

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.
    

Intervention name(s): Virtual environment rehabilitation; Paper-pencil rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive deficit; schizophrenia; major depressive disorder; virtual environment; cognitive rehabilitation