Functional Remediation for Older Adults with Bipolar Disorder (FROA-BD): Study protocol for a randomized controlled trial

Abstract

Background: Older Adults with Bipolar Disorder (OABD) show cognitive impairments with a negative impact on psychosocial functioning and quality of life. However, to date any intervention for the improvement of functioning has been developed for OABD. The current project aims to demonstrate the efficacy of the Functional Remediation program (FR) specifically adapted to OABD, over 60 years old, for improving functional outcome. Methods: This is an experimental, randomized-controlled trial. Two groups will be included: the experimental group (n = 42) will receive a 4-month intervention consisting of 32 sessions of treatment and the control group which will receive treatment as usual (TAU) (n = 42). The intervention will result from the adaptation of the Functional Remediation program for OABD (FROA-BD), that has already proven its efficacy at improving psychosocial functioning in patients with bipolar disorder. Clinical, neuropsychological and functional evaluations will be carried out at baseline, post-intervention and follow-up (one year after baseline evaluation). We hypothesized that patients who have undergone the intervention FROA-BD will improve their psychosocial functioning, cognitive performance, quality of life and well-being. We also hypothesized that all these changes will remain stable after eight month follow-up. Conclusions:The results will provide evidence of the efficacy in improving psychosocial functioning, cognitive performance and quality of life applying the FROA-BD. This project consists in the first attempt to adapt the FR program to OABD population who needs specific needs and approaches. The novelty of this contribution represents an advance in the framework of psychological treatment in later-life bipolar disorder.