Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders
Condition: Psychotic Disorders; Schizophrenia; Schizoaffective Disorder; Delusional Disorder; Substance-Induced Psychotic Disorder
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia, Paranoid; Shared Paranoid Disorder
Study type: Interventional

Summary: 
      The aim of this study is to test the effect of cognitive stimulation (CS), applied
      individually and at home, on the overall cognitive functioning, emotional state,
      functionality, and quality of life (QoL) in adults with psychotic disorders. To this end, a
      randomised controlled clinical trial will be conducted in which selected participants will be
      randomly assigned to an individual intervention group using CS or a control group. The CS
      program is adapted from other existing protocol, composed of 32 sessions. Each session will
      last 45 minutes and will be held twice weekly. There will be four evaluation points
      (baseline, intra-evaluation - after 8 weeks of intervention, post-evaluation - after 16 weeks
      of intervention, follow-up - after 8 weeks of the end of intervention).
    

Detailed description: 
      Epidemiological studies indicate that Portugal has one of the highest prevalence rates of
      mental disorders in Europe. In 2016, one in five Portuguese suffered from a psychiatric
      illness and the network of Integrated Continuous Care in mental health is small, which is a
      major constraint to rehabilitation and support responses for people with mental health
      problems.

      It is important to include psychologists and neuropsychologists in multidisciplinary teams,
      in actions related to mental health promotion and mental illness prevention programs, so that
      they can provide more comprehensive interventions for other effects of chronic mental health
      conditions, such as cognitive decline.

      There is evidence linking psychotic disorders to impairments in functioning in most cognitive
      domains, including memory, executive functions, and attention, and that cognitive ageing in
      some areas may be accelerated in individuals with psychotic disorders. Thus, it is important
      to focus interventions on cognitive functioning in patients with psychosis, even after acute
      psychotic symptoms have improved. Executive functions appear to be of particular importance
      in the context of mental health problems, as they appear to be particularly integral for
      psychosocial functioning and the completion of instrumental activities of daily living. There
      is evidence that CS interventions in individual format are associated with greater
      effectiveness.

      Many studies have supported the effectiveness and accessibility of home-based interventions
      in people with chronic mental illness. Yet, there are few published studies on continuous
      intervention in people with chronic mental illness and even more limited knowledge of how
      cognitive stimulation can help chronic mental health patients, including those with
      psychosis, to function.

      One Portuguese study about the effect of an individual CS program in a home setting on
      cognitive and mood functioning in adults with psychotic disorders was tested, showed
      encouraging results and presented in detail an intervention protocol. However, it also
      presents some important limitations (e.g., convenience sample, lack of follow-up evaluation).

      This study aims to overcome those limitations, through a randomised controlled trial, and, in
      addition to testing the effect of the CS program on global cognition, it also aims to assess
      its effect on emotional state, daily functioning, and quality of life.
    

Intervention name(s): Individual cognitive stimulation therapy (iCST)
Intervention type(s): Behavioral
Intervention description(s): The intervention group will receive 32 individual CS sessions per participant. Each session will last approximately 45 minutes and will have the following structure: session introduction (5 minutes); reality orientation (10 minutes); stimulation of cognitive domain (25 minutes); session closure (5 minutes). The sessions will be led by a previously trained therapist. The intervention program will include several activities based on the principles of CS and adjusted for participants with psychotic disorders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognition; mood; executive functions; quality of life; non-pharmacological therapy; randomised controlled trial; schizophrenia; psychotic disorders; cognitive stimulation