Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577508
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-09-30
Brief Title:
A Trial of Functional Remediation in Patients With Bipolar Disorder
Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Organization:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study Overview
Official Title:
Efficacy of Functional Remediation on Cognitive and Psychosocial Functioning in Patients With Bipolar Disorder a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the last decade several evidences show that cognitive impairment is a major feature of bipolar disorder BD that is strongly associated with patients functional outcome The most affected cognitive domains in BD are attention memory and executive functions BD represents a mental illness of considerable therapeutic complexity and the fight against cognitive and functional deterioration have contributed to increase the interest in the development of specific therapeutic strategiesThere is the need of new non-pharmacological interventions in BD in order to improve not only affective symptoms but also cognitive dysfunctions with the final goal to achieve full functional recovery The present study is focused on Functional Remediation FR a novel group intervention created by the Bipolar Disorder Unit of the Hospital Clinic of Barcelona and designed specifically for bipolar patients based on a neuro-cognitive-behavioural approach It involves neurocognitive and psychoeducation techniques 21 weekly sessions The present study aims to assess FR efficacy in improving cognitive deficits and psychosocial functioning in a sample of euthymic patients with BD compared to standard treatment TAU This is a randomized and rater-blind trial involving 54 adult out-patients diagnosed with BD I or II DSM-5 criteria and clinically stable for at least two months Patients will be assessed at baseline post-treatment and 6-months follow-up on validated cognitive clinical and functional rating scales The main result expected is that patients receiving FR will show better cognitive and psychosocial performance further confirming the preliminary evidence on the utility of FR as an element of standard care for BD patients
Detailed Description:
The main objective of this randomized rater-blind controlled trial is to evaluate the efficacy of Functional Remediation FR in improving functional clinical and cognitive outcomes in euthymic and clinically stable patients with Bipolar Disorder
FR is a novel group-based intervention based on a neurocognitive-behavioural approach making use of ecological techniques specifically developed for patients with Bipolar Disorder and aimed at restoring psychosocial functioning in this population
The study will involve subjects recruited from outpatient clinics residential or semi-residential care within the Department of Mental Health and Addiction Services of ASST Spedali Civili Brescia Italy
Study participants will be assigned via central randomization to either FR or treatment as usual the latter consisting of evidence-based drug treatment and case management
Pharmacological treatment will be maintained stable during the course of the trial but no restriction will be applied in terms of access to evidence-based non-pharmacological interventions
Efficacy of the study intervention lasting 6 months will be assessed at post-treatment and later investigated at 6-months follow-up
The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice It will take place within an experimental project related to the PhD Course in Biomedical Sciences and Translational Medicine curriculum Neuroscience of the University of Brescia Italy
FR is a novel group-based intervention based on a neurocognitive-behavioural approach making use of ecological techniques specifically developed for patients with Bipolar Disorder and aimed at restoring psychosocial functioning in this population
The study will involve subjects recruited from outpatient clinics residential or semi-residential care within the Department of Mental Health and Addiction Services of ASST Spedali Civili Brescia Italy
Study participants will be assigned via central randomization to either FR or treatment as usual the latter consisting of evidence-based drug treatment and case management
Pharmacological treatment will be maintained stable during the course of the trial but no restriction will be applied in terms of access to evidence-based non-pharmacological interventions
Efficacy of the study intervention lasting 6 months will be assessed at post-treatment and later investigated at 6-months follow-up
The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice It will take place within an experimental project related to the PhD Course in Biomedical Sciences and Translational Medicine curriculum Neuroscience of the University of Brescia Italy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None