Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797351
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2021-03-07
Brief Title:
Bi-REAL - DBT Skills Online Group Intervention for Bipolar Disorder
Sponsor:
Julieta Azevedo
Organization:
University of Coimbra
Study Overview
Official Title:
Acceptability and Feasibility of a DBT Skills Group Intervention for Bipolar Disorder - a Randomized Pilot Trial
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
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:
BI-REAL
Brief Summary:
Bipolar disorder BD is a serious mental disorder characterized by episodes of maniahypomania andor depression Compared to the general population these individuals present functional impairment and life interference subclinical symptoms even between mood episodes and higher mood instability and suicide rates with a lower quality of life Given the chronic and phasic course of this disorder patients are great consumers of health services and in Portugal there is no specialised psychotherapeutic approach to Bipolar Disorder having pharmacological treatment alone as the main therapeutic response and a considerable number of patients are not fully stabilized with drug treatments experiencing residual symptoms Although studies suggest that certain psychological therapies can be helpful for people experiencing full mood disorder episodes or to reduce risk of future episodes there are no gold standard and evidence-based psychological therapies for BD and recent systematic reviews on psychosocial interventions for BD identify Dialectical-Behavior Therapy DBT as promising
Our research is sustained in a recovery based perspective which means we intend to develop a sense of hope understanding empowerment and work towards a meaningful and satisfying life focusing on less clinical outcomes Recovery is a concept that looks beyond the traditional clinical definitions which focus on reduced symptomatology hospitalisation and medication compliance and focuses on having a better sense of living even though you might have some clinical symptomatology
DBT was developed as an approach for highly emotionally and behaviourally dysregulated people and it has been referred as promising in BD patients DBT aims to give individuals who experience quick and intense shifts in mood skills to manage and regulate their emotions
People with Bipolar Disorder can benefit from skills to regulate their emotions and interpersonal efficacy which is frequently affected by mood changes and therefore have a life worth living feeling skillful and empowered to deal with challenges
Our study aimed to develop a 12 session DBT-skills group adapting the sessions and skills to be used with this client group Bi-REAL - Respond Effectively and Live mindfully
This study aims to test acceptability feasibility and efficacy of this 12 session DBT skills pilot randomized group intervention for patients with Bipolar Disorders
Our research is sustained in a recovery based perspective which means we intend to develop a sense of hope understanding empowerment and work towards a meaningful and satisfying life focusing on less clinical outcomes Recovery is a concept that looks beyond the traditional clinical definitions which focus on reduced symptomatology hospitalisation and medication compliance and focuses on having a better sense of living even though you might have some clinical symptomatology
DBT was developed as an approach for highly emotionally and behaviourally dysregulated people and it has been referred as promising in BD patients DBT aims to give individuals who experience quick and intense shifts in mood skills to manage and regulate their emotions
People with Bipolar Disorder can benefit from skills to regulate their emotions and interpersonal efficacy which is frequently affected by mood changes and therefore have a life worth living feeling skillful and empowered to deal with challenges
Our study aimed to develop a 12 session DBT-skills group adapting the sessions and skills to be used with this client group Bi-REAL - Respond Effectively and Live mindfully
This study aims to test acceptability feasibility and efficacy of this 12 session DBT skills pilot randomized group intervention for patients with Bipolar Disorders
Detailed Description:
Bipolar disorder BD is a serious mental disorder characterized by episodes of mania or hypomania and depression occurring with a typically cyclical course In addition to mood instability BD has been associated with significant functional impairment lower quality of life and higher rates of suicide compared to the general population Prevalence of BD in Europe is of approximately 1 with few evidences of gender differences Despite the advances in pharmacological and non-pharmacological treatments BD still entails multiple relapses Prediction of the course and outcome continues to be challenging and BD has been considered the sixth leading cause of disability-adjusted life years in the world with high costs to society patients and mental health services
Even though the etiology of BD is still unclear it is multifactorial with multiple genetic and environmental influences interacting with each other Fewer studies have explored psychosocial factors in BDs development and maintenance however some risk factors have been identified namely negative early experiences family characteristics and adverse life circumstances Researchers also found significantly higher levels of childhood abuse and current internalized shame in BD individuals when compared to a control group It is also known that stressful life events possibly work as triggers in affective symptoms and they are frequently stigmatized because of their condition jeopardizing their social and work context
Pharmacological interventions prevail as the primary management tool in BD however most patients are not fully stabilized on drug therapies alone and a large number of patients experience residual symptoms so that full functional recovery is uncommon Hence growing evidence and international guidelines support the need to use psychosocial interventions as adjuvant therapies to improve recovery in BD
Our research is sustained in a recovery based perspective which means we intend to develop a sense of hope understanding empowerment and work towards a meaningful and satisfying life focusing on less clinical outcomes Recovery is a concept that looks beyond the traditional clinical definitions which focus on reduced symptomatology hospitalisation and medication compliance and focuses on having a better sense of living even though you might have some clinical symptomatology
The most empirically tested psychosocial interventions for BD include Psychoeducation PE and Cognitive-Behavioral Therapy CBT with supporting evidence of their efficacy However there are also contradictory findings contesting the efficacy of CBT and PE and that is why there is still no Goldstandard regarding BD psychosocial intervention A recent review regarding empirically supported psychosocial interventions for BD discusses promising findings regarding contextual therapies namely Dialectical Behavior Therapy DBT and further research is encouraged
DBT seems to be a promising approach to apply with BD given its components for emotion regulation and has already been found to reduce depressive and manic symptoms as well as to improve emotional dysregulation in BD groups Based on the above-mentioned further empirical research to clarify about contextual therapies efficacy particularly DBT for BD is essential and necessary which is why we constructed our 12-session skills intervention Bi-REAL Respond Effectively and Live mindfully based on some preliminary studies and suggested adaptations for DBT for Bipolar Disorder
This study aims to test acceptability feasibility and efficacy of this 12 session DBT skills pilot randomized group intervention for patients with Bipolar Disorders
Even though the etiology of BD is still unclear it is multifactorial with multiple genetic and environmental influences interacting with each other Fewer studies have explored psychosocial factors in BDs development and maintenance however some risk factors have been identified namely negative early experiences family characteristics and adverse life circumstances Researchers also found significantly higher levels of childhood abuse and current internalized shame in BD individuals when compared to a control group It is also known that stressful life events possibly work as triggers in affective symptoms and they are frequently stigmatized because of their condition jeopardizing their social and work context
Pharmacological interventions prevail as the primary management tool in BD however most patients are not fully stabilized on drug therapies alone and a large number of patients experience residual symptoms so that full functional recovery is uncommon Hence growing evidence and international guidelines support the need to use psychosocial interventions as adjuvant therapies to improve recovery in BD
Our research is sustained in a recovery based perspective which means we intend to develop a sense of hope understanding empowerment and work towards a meaningful and satisfying life focusing on less clinical outcomes Recovery is a concept that looks beyond the traditional clinical definitions which focus on reduced symptomatology hospitalisation and medication compliance and focuses on having a better sense of living even though you might have some clinical symptomatology
The most empirically tested psychosocial interventions for BD include Psychoeducation PE and Cognitive-Behavioral Therapy CBT with supporting evidence of their efficacy However there are also contradictory findings contesting the efficacy of CBT and PE and that is why there is still no Goldstandard regarding BD psychosocial intervention A recent review regarding empirically supported psychosocial interventions for BD discusses promising findings regarding contextual therapies namely Dialectical Behavior Therapy DBT and further research is encouraged
DBT seems to be a promising approach to apply with BD given its components for emotion regulation and has already been found to reduce depressive and manic symptoms as well as to improve emotional dysregulation in BD groups Based on the above-mentioned further empirical research to clarify about contextual therapies efficacy particularly DBT for BD is essential and necessary which is why we constructed our 12-session skills intervention Bi-REAL Respond Effectively and Live mindfully based on some preliminary studies and suggested adaptations for DBT for Bipolar Disorder
This study aims to test acceptability feasibility and efficacy of this 12 session DBT skills pilot randomized group intervention for patients with Bipolar Disorders
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