Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
Bipolar Disorder
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants are distributed into 2 experimental groups: Experimental Group Condition 1: Treatment as Usual - Public health services and psychiatric support + (1 Pre-session) 12 session DBT Skills group Experimental Group Condition 2: Specialized support (Psychoeducation in Bipolar Disorder + Psychological support) + (1 Pre-session) 12 session DBT Skills group + TAU Control Group Condition 1: TAU Control Group Condition 2: Specialized support (Psychoeducation in Bipolar Disorder + Psychological support) + TAUMasking: Single (Outcomes Assessor)Masking Description: After the intervention participants will be interviewed by a health professional, not involved in the study, to assess feedback - regarding facilitators, program sessions, interest and usefulness.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 su...

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 BD's 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.

Tracking Information

NCT #
NCT04797351
Collaborators
  • Fundação para a Ciência e a Tecnologia
  • ADEB - Associação de Apoio a Doentes Depressivos e Bipolares
  • Centro Hospitalar e Universitário de Coimbra, E.P.E.
  • Centro Hospitalar de Leiria
  • Centro Hospitalar do Oeste E.P.E.
  • CINEICC - Center for Research in Neuropsychology and Cognitive Behavioral Intervention
  • IPM - Institute of Psychological Medicine, Faculty of Medicine, University of Coimbra
Investigators
Principal Investigator: Julieta M Azevedo, MS University of Coimbra - CINEICC