Efficacy of an Innovative E-neurocognitive Module for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Between 40% and 60% bipolar patients experience neurocognitive impairment not only during
      acute mood episodes but also during remission periods. These rates are quite similar to those
      reported as regards to functional impairment. In fact, it is estimated that only one third of
      patients achieve full social and occupational recovery and get back to their premorbid
      levels. Moreover, neurocognitive deficits, together with other clinical and sociodemographic
      variables are thought to contribute to functional impairment for bipolar disorder, similarly
      to that found in schizophrenia. Little is published with regard to neurocognitive remediation
      in bipolar disorder. The first open label study on bipolar disorder was published in 2010
      with positive results. Recently, a multicenter randomized clinical trial coordinated showed
      efficacy of an innovative intervention at improving functioning and reducing disability of
      bipolar patients. There is a need of investigating novel and creative ways to work on
      cognitive deficits including new technologies in order to reduce costs and increasing
      benefits for patients. No study addressing computerized cognitive training in bipolar
      disorder has been developed so far. This project aims to test the efficacy of an
      e-neurocognitive module as an adjunct to functional remediation in bipolar patients.
    

Detailed description: 
      This is a randomized clinical study, rater-blind, placebo-controlled stratified by age, sex
      and educational level to assess the efficacy of a new program, an adjunctive e-neurocognitive
      module, to functional remediation intervention. The primary outcome measure will be the
      improvement in global psychosocial functioning measured blindly as the mean change in score
      Functioning Assessment Short Test from baseline to endpoint. The sample will be composed by
      132 euthymic bipolar (type I or II) patients who will be assessed at baseline regarding
      several clinical, functional and neuropsychological variables. Subsequently, the patients
      will consecutively start the functional remediation groups, once the group will be finished
      the patients will be randomly assigned (1:1) to two different groups. The experimental group
      (EG, 66 patients) will take part of a 12-week extension with a total of 36 hours training
      with the e-cognitive module tailored for bipolar patients whilst the control group (CG, 66
      patients) will not receive any sort of add-on training just the recommendations from the
      therapists to train the same amount of time that the experimental group: twice per week a
      total of 3 hours with the material provided during the functional remediation group. All
      patients will keep on receiving standard psychiatric treatment according to the local
      treatment guidelines for the management of bipolar patients. At nine months, once the home
      training has been completed, all patients will be assessed again regarding several clinical,
      functional and neuropsychological variables. All patients will be assessed monthly regarding
      several clinical variables, including mood measurements (YMRS and HDRS). At 24 months from
      baseline, all measurements will be repeated to all patients. In total, three assessments will
      be conducted (baseline, post-intervention and at 2 years follow-up). The first active
      intervention that all patients will be receiving is the Functional Remediation Program:

      * The Functional Remediation Program which consists of 21 weekly sessions, 90 minutes each.
      This intervention addresses neurocognitive issues such as attention, memory and executive
      functions but focuses even more on enhancing functioning in daily routine. The content of
      this intervention is based on ecological tasks to be performed in two settings, in the
      clinical but also at home. Patients were trained with exercises in memory, attention, problem
      solving and reasoning, multitasking and organization in order to improve their functional
      outcome. Most of the techniques were based on "paper and pencil" tasks and group activities.

      After the randomization some patients will continue their training through an
      e-neurocognitive module specially adaptated for bipolar patients.

        1. The e- neurocognitive module will be tailored to bipolar patient's cognitive and
           functional profile using a newly developed personalized and cost effective technology
           adapted from a program that has been applied to patients with acquired brain injury. The
           total duration will be of 36 hours distributed as 1'5 hours twice per week with the aim
           to enhance cognitive impairment and functioning using a flexible system (website).
           Therefore, the novelty of this current project is that this is the first trial to test
           the implementation of an innovative neurocognitive intervention for bipolar patients and
           its impact on daily life, using new technologies, reducing stigma, transferring
           responsibilities to the patient, providing the opportunity to improve cognitive deficits
           at home, being monitored by a neuropsychologist from the hospital, with a good balance
           costs-benefits. The emphasis will stress on social cognition skills which are highly
           correlated with psychosocial functioning.

        2. Control group. Will receive standard instructions once finished the functional
           remediation group in order to keep training at home.

      In the two groups pharmacological treatment will be prescribed according to the local
      treatment guidelines for the management of bipolar patients. Criteria for discontinuation
      during this study will be one or more of the following: 1) Missing more than five sessions
      during the Functional Remediation intervention 2) Hospitalization for any type of episode or
      clinical meaningful affective relapse 3) Withdrawal of consent.
    

Intervention name(s): E-neurocognitive module
Intervention type(s): Behavioral
Intervention description(s): The experimental group will take part of a 12-week extension with a total of 36 hours training with the e-neurocognitive module tailored for bipolar patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: cognition; psychosocial functioning