BI-REAL: Bi-REAL - DBT Skills Online Group Intervention for Bipolar Disorder

Sponsor

Julieta Azevedo (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04797351

Collaborator

Fundação para a Ciência e a Tecnologia (Other), ADEB - Associação de Apoio a Doentes Depressivos e Bipolares (Other), Centro Hospitalar e Universitário de Coimbra, E.P.E. (Other), Centro Hospitalar de Leiria (Other), Centro Hospitalar do Oeste E.P.E. (Other), CINEICC - Center for Research in Neuropsychology and Cognitive Behavioral Intervention (Other), IPM - Institute of Psychological Medicine, Faculty of Medicine, University of Coimbra (Other)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Behavioral: Dialectical Behavior Therapy - Skills	N/A

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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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) + TAUParticipants 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) + TAU

Masking:

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

Official Title:

Acceptability and Feasibility of a DBT Skills Group Intervention for Bipolar Disorder - a Randomized Pilot Trial

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Condition 1 - Experimental Group Pre-treatment session + 12 Sessions Group Intervention TAU - Treatment as usual (Psychiatric support through Public health system)	Behavioral: Dialectical Behavior Therapy - Skills Pre-treatment session + 12 sessions DBT Skills Group (only) intervention Other Names: Bi-REAL
No Intervention: Condition 1 - Control Group 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)
Experimental: Condition 2 - Experimental Group Pre-treatment session + 12 Sessions Group Intervention TAU - Treatment as usual (Psychiatric support through Public health system) Specialized support for Bipolar Disorder (members of an association - ADEB - that provides psychoeducation about BD, and psychological support)	Behavioral: Dialectical Behavior Therapy - Skills Pre-treatment session + 12 sessions DBT Skills Group (only) intervention Other Names: Bi-REAL
No Intervention: Condition 2 - Control Group TAU - Treatment as usual (Psychiatric support through Public health system) Specialized support for Bipolar Disorder (members of an association - ADEB - that provides psychoeducation about BD, and psychological individual support) Waiting list (will have access to the intervention program BI-REAL after the 3 month follow up assessment)

Outcome Measures

Primary Outcome Measures

Sense of personal recovery [6 months (from Baseline to 3-months follow-up)]
Assessed by the Bipolar Recovery Questionnaire (scores vary from 0-3600) higher scores mean a better outcome
Changes in quality of life [6 months (from Baseline to 3-months follow-up)]
Assessed by Quality of Life Questionnaire for Bipolar Disorder (scores from 1-60) higher scores mean a better outcome

Secondary Outcome Measures

Changes in activation and reactivity levels [6 months (from Baseline to 3-months follow-up)]
Assessed through Multidimensional assessment of thymic states (0-200) continuum between Hypo-reactivity/Hyper-reactivity - median scores around 100 mean better outcome
Changes in Distress Tolerance [6 months (from Baseline to 3-months follow-up)]
Assessed through Distress Tolerance Scale (1-75) - higher scores mean a better outcome
Changes in psychopathology symptoms [6 months (from Baseline to 3-months follow-up)]
Assessed through Depression and Anxiety Stress Scale - lower scores mean a better outcome
Changes in Rumination [6 months (from Baseline to 3-months follow-up)]
Assessed through Rumination-Reflexion Questionnaire (RRQ-10) lower scores mean a better outcome
Changes in symptoms interference with life [6 months (from Baseline to 3-months follow-up)]
Assessed through semi-structured clinical interview for Bipolar Disorder (CIBD) lower scored mean less interference, thus better outcome

Other Outcome Measures

Changes in Self-criticism [6 months (from Baseline to 3-months follow-up)]
Assessed through Forms of self-criticizing/attacking and self-reassuring scale - lower scores in self-criticising mean a better outcome
Changes in Self-reassurance [6 months (from Baseline to 3-months follow-up)]
Assessed through Forms of self-criticizing/attacking and self-reassuring scale - higher scores in self-reassurance mean a better outcome
Changes in Awareness and acceptance of experience [6 months (from Baseline to 3-months follow-up)]
Assessed through Philadelphia Mindfulness Scale (PHLMS) - higher scores mean a better outcome
Changes in difficulties in emotional regulation [6 months (from Baseline to 3-months follow-up)]
Assessed through Difficulties in Emotion Regulation Scale (DERS) - lower scores mean a better outcome
Changes in internal and external shame [6 months (from Baseline to 3-months follow-up)]
Assessed through Internal and External Shame Scale (IESS) - lower scores mean a better outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A diagnosis of bipolar disorder according to DSM-5 (BD-I, BD-II and Other (un)specified bipolar and related disorder) (APA, 2013), identified by psychiatrists or any assistant physician, and confirmed through CIBD;
A history of two or more episodes of illness meeting DSM-5 criteria for mania, hypomania, major depressive disorder or mixed affective disorder, one of which must have been within 5 year of recruitment.
Mood symptoms cause interference in their life (currently)
Having a computer/tablet with access to internet, zoom installed, a microphone and camera.
Living in Portugal and with good comprehension of Portuguese at a level sufficient to complete self-report instruments and clinical interview.

Exclusion Criteria:

Active suicide ideation
Bipolar disorder secondary to an organic cause;
Continuous illicit substance misuse resulting in uncertain primary diagnosis;
Acute episode of mania, hypomania or major depressive episode;
Other high risk pervasive disorders such as Borderline Personality Disorder; persistent self-injury;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Psychology and Educational Sciences - University of Coimbra	Coimbra		Portugal	3000-115

Sponsors and Collaborators

Julieta Azevedo
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