Effectiveness of Neuroadaptive Cognitive Training in Adolescents at Risk for Psychosis
Condition: Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of intensive computerized cognitive training in
      preventing the onset of psychotic disorder and improving adaptive functioning in adolescents
      at high risk of schizophrenia.
    

Detailed description: 
      Schizophrenia is a severe mental disorder that is marked by significant disruption in a
      person's thought and emotional processes, frequently involving psychotic features.
      Identifying behavioral changes and symptoms that indicate the beginning stages of
      schizophrenia is important for early intervention and prevention of a full psychotic episode.
      These initial symptoms, known as the prodromal symptoms of psychosis, may include odd
      behaviors, increased social withdrawal, difficulty concentrating, inappropriate emotional
      responses, suspicion of others, and dramatic sleep and appetite changes. Common treatments
      for adolescents demonstrating prodromal symptoms include forms of psychotherapy, nutritional
      training, and low doses of medication. As a form of psychotherapy, neuroadaptive cognitive
      training exercises delivered on a computer may be the most effective means of remediating the
      thinking difficulties of adolescents who are experiencing prodromal symptoms and are at risk
      for developing a first psychotic episode. This study will evaluate the effectiveness of
      intensive computerized neuroadaptive cognitive training exercises in preventing the onset of
      psychotic disorder and improving adaptive functioning in adolescents at high risk of
      schizophrenia.

      Participation in this study will last 24 months and will involve both healthy participants
      and participants at high risk of schizophrenia. Healthy participants will only participate
      for 12 months. All participants will undergo baseline assessments that will include an
      interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance
      imaging (MRI) scans. Participants at high risk of schizophrenia will then be assigned
      randomly to receive treatment with either computerized neuroadaptive cognitive training or
      commercially available computer games. Healthy participants will receive treatment with
      computerized neuroadaptive cognitive training only. All participants will be asked to
      complete 60-minute sessions of their assigned treatments 5 days per week for 8 weeks. For
      participants receiving cognitive training, exercises will focus on improving speed and
      accuracy in the perception of and response to verbal and visuospatial targets. The treatment
      will focus on targeted cognitive training (TCT). Participants assigned to practice computer
      games will play standard, commercially available games, with no targeted response.

      Participants will repeat baseline assessments at post treatment and Month 6 of follow-up. The
      EEG and MRI will be repeated only at the Week 8 assessment visit. There will be a blood draw
      at Week 2 of treatment as well. After the Month 6 assessment, healthy controls will be
      complete, and the at risk participants will continue to be followed up out to 24 months.
    

Intervention name(s): Neuroadaptive cognitive training; Computer games
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.; The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ultra High Risk of Schizophrenia; Prodrome; Psychosis; Schizophrenia; Cognitive Remediation