Study Efficacy of Enhancing Cognitive Reserve in Patients With a First Bipolar Episode - Trial NCT06081634

Timeline & Enrollment

Primary Outcome

Cognitive reserve

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.

ICD-10 Classifications