Study Efficacy of Enhancing Cognitive Reserve in Patients With a First Bipolar Episode
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      This study aims to adapt and apply a psychological program aimed at improving cognitive
      reserve (CR) in bipolar patients who have recently presented a first episode of the illness.
      The purpose of this project is to test both the effectiveness of the psychological
      intervention as well as the stability of the obtained results after nine months of follow-up.
      One-hundred and twenty patients (60 patients each centre) will be recruited and assessed with
      clinical, functioning, quality of life, neuropsychological and RC assessment tools. Then,
      participants will be randomly assigned to two different conditions: the experimental one,
      consisting in the implementation of the psychological intervention aiming at improving CR
      (n=60), and the control one, in which the usual pharmacological treatment will be carried on
      (n=60). Once the psychological intervention has finished (3 months) re-assessment of all the
      explored variables at baseline will be performed. Finally, after 12 months from the baseline
      visit, a re-assessment of all the participants in the study will be carried out to verify
      that post-intervention obtained results remain stable throughout the complete follow-up
      period. The investigators hypothesized that patients with a recent first episode who have
      undergone the intervention program will improve their CR as well as measures related to the
      severity of the difficulties observed at baseline concerning clinical, functioning, quality
      of life and neurocognitive performance. A second hypotheses is that all these changes will
      remain stable after nine month follow-up.
    


Intervention name(s): Enhancing cognitive reserve; Treatment as Usual
Intervention type(s): Behavioral; Other
Intervention description(s): Intervention in group format (6-8 patients) consisting of 12 weekly sessions, each lasting approximately 60 minutes. The aim of this intervention is to offer a series of strategies to increase academic and/or work achievements, leisure and free time activities, as well as an improvement in the level of neurocognitive functioning. Most of the tasks to be carried out are based on the use of pencil and paper with audiovisual support. Technological resources such as the use of the Internet and some telephone applications will also be used in some sessions. For those sessions in which the practice of mindfulness techniques will be promoted, a virtual reality device will be used per patient.; The group will only receive the pharmacoloical treatment according to the based guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental, multicentre, randomised, test-retest and control group clinical study to evaluate the efficacy of a cognitive reserve enhancement programme in patients with a diagnosis of bipolar disorder or schizoaffective disorder whose first episode has occurred within the last five years. Patients will be randomised into two groups: one group of patients will receive a psychological intervention for cognitive enhancement and another group of patients will receive only the usual pharmacological treatment (TAU).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive reserve