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NCT06081634Completed

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

Study on the Efficacy of a Psychological Approach for the Enhancement of Cognitive Reserve in a Bipolar Population With a Recent First Episode
Hospital Clinic of BarcelonaClinicalTrials.govbehavioral
Study focus
Disease/Condition
Bipolar Disorder
Drug/Device/Intervention
Enhancing cognitive reserve
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Hospital Clinic of Barcelona
Location
Barcelona, Spain
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2019
End date
Jun 30, 2023
Enrollment
120 participants
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
Bipolar affective disorderBipolar affective disorder, unspecifiedOther bipolar affective disordersBipolar affective disorder, currently in remissionBipolar affective disorder, current episode mixed
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06081634
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06081634 through Pure Global AI's free database. This phase not specified trial is sponsored by Hospital Clinic of Barcelona and is currently Completed. The study focuses on Bipolar Disorder. Target enrollment is 120 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.