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

July 14, 2023 updated by: Julieta Azevedo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3000-115
        • Faculty of Psychology and Educational Sciences - University of Coimbra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sense of personal recovery
Time Frame: 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
6 months (from Baseline to 3-months follow-up)
Changes in quality of life
Time Frame: 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
6 months (from Baseline to 3-months follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in activation and reactivity levels
Time Frame: 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
6 months (from Baseline to 3-months follow-up)
Changes in Distress Tolerance
Time Frame: 6 months (from Baseline to 3-months follow-up)
Assessed through Distress Tolerance Scale (1-75) - higher scores mean a better outcome
6 months (from Baseline to 3-months follow-up)
Changes in psychopathology symptoms
Time Frame: 6 months (from Baseline to 3-months follow-up)
Assessed through Depression and Anxiety Stress Scale - lower scores mean a better outcome
6 months (from Baseline to 3-months follow-up)
Changes in Rumination
Time Frame: 6 months (from Baseline to 3-months follow-up)
Assessed through Rumination-Reflexion Questionnaire (RRQ-10) lower scores mean a better outcome
6 months (from Baseline to 3-months follow-up)
Changes in symptoms interference with life
Time Frame: 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
6 months (from Baseline to 3-months follow-up)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Self-criticism
Time Frame: 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
6 months (from Baseline to 3-months follow-up)
Changes in Self-reassurance
Time Frame: 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
6 months (from Baseline to 3-months follow-up)
Changes in Awareness and acceptance of experience
Time Frame: 6 months (from Baseline to 3-months follow-up)
Assessed through Philadelphia Mindfulness Scale (PHLMS) - higher scores mean a better outcome
6 months (from Baseline to 3-months follow-up)
Changes in difficulties in emotional regulation
Time Frame: 6 months (from Baseline to 3-months follow-up)
Assessed through Difficulties in Emotion Regulation Scale (DERS) - lower scores mean a better outcome
6 months (from Baseline to 3-months follow-up)
Changes in internal and external shame
Time Frame: 6 months (from Baseline to 3-months follow-up)
Assessed through Internal and External Shame Scale (IESS) - lower scores mean a better outcome
6 months (from Baseline to 3-months follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julieta Azevedo

Collaborators

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

Investigators

  • Principal Investigator: Julieta M Azevedo, MS, University of Coimbra - CINEICC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

March 7, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD/130116/2017_Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Sharing Time Frame

After September 2022

IPD Sharing Access Criteria

Being a health professional/researcher and present research related interests. Submit a request.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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