Bi-REAL - DBT Skills Online Group Intervention for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Bipolar disorder (BD) is a serious mental disorder characterized by episodes of
      mania/hypomania and/or 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.
    

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 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.
    

Intervention name(s): Dialectical Behavior Therapy - Skills
Intervention type(s): Behavioral
Intervention description(s): Pre-treatment session + 12 sessions DBT Skills Group (only) intervention
Other intervention name(s): Bi-REAL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly distributed into 2 groups:
Experimental Group: 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 + Waiting List
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; DBT Skills; Recovery; Emotion Regulation