An interventional study of Dialectical Behavior Therapy - Skills in Bipolar Disorder, sponsored by Julieta Azevedo. Completed at 1 site in Portugal. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Julieta Azevedo · Not applicable, Interventional, and Treatment
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.
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.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's enrollment of 109 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →This is the only study on the registry with Julieta Azevedo as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Pre-treatment session + 12 Sessions Group Intervention * TAU - Treatment as usual (Psychiatric support through Public health system)
Behavioral: Dialectical Behavior Therapy - Skills
* TAU - Treatment as usual (Psychiatric support through Public health system) * Waiting list (will have access to the intervention program BI-REAL after the 3 month follow up assessment)
Pre-treatment session + 12 sessions DBT Skills Group (only) intervention
Also known as: Bi-REAL
Sense of personal recovery
Assessed by the Bipolar Recovery Questionnaire (scores vary from 0-3600) higher scores mean a better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
Changes in quality of life
Assessed by Quality of Life Questionnaire for Bipolar Disorder (scores from 1-60) higher scores mean a better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
Changes in activation and reactivity levels
Assessed through Multidimensional assessment of thymic states (0-200) continuum between Hypo-reactivity/Hyper-reactivity - median scores around 100 mean better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
Changes in Distress Tolerance
Assessed through Distress Tolerance Scale (1-75) - higher scores mean a better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
Changes in psychopathology symptoms
Assessed through Depression and Anxiety Stress Scale - lower scores mean a better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
Changes in Rumination
Assessed through Rumination-Reflexion Questionnaire (RRQ-10) lower scores mean a better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
Changes in symptoms interference with life
Assessed through semi-structured clinical interview for Bipolar Disorder (CIBD) lower scored mean less interference, thus better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
Changes in Self-criticism
Assessed through Forms of self-criticizing/attacking and self-reassuring scale - lower scores in self-criticising mean a better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
Changes in Self-reassurance
Assessed through Forms of self-criticizing/attacking and self-reassuring scale - higher scores in self-reassurance mean a better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
Changes in Awareness and acceptance of experience
Assessed through Philadelphia Mindfulness Scale (PHLMS) - higher scores mean a better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
Changes in difficulties in emotional regulation
Assessed through Difficulties in Emotion Regulation Scale (DERS) - lower scores mean a better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
Changes in internal and external shame
Assessed through Internal and External Shame Scale (IESS) - lower scores mean a better outcome
Time frame: 6 months (from Baseline to 3-months follow-up)
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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