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

NCT04797351 | Completed

• 1 other identifier: BD/130116/2017_Pilot
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; DBT Skills; Recovery; Emotion Regulation

Outcome Measures

Primary Outcomes (2)

• Sense of personal recovery

  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

  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 Outcomes (5)

• Changes in activation and reactivity levels

  6 months (from Baseline to 3-months follow-up)

• Changes in Distress Tolerance

  6 months (from Baseline to 3-months follow-up)

• Changes in psychopathology symptoms

  6 months (from Baseline to 3-months follow-up)

• Changes in Rumination

  6 months (from Baseline to 3-months follow-up)

• Changes in symptoms interference with life

  6 months (from Baseline to 3-months follow-up)

Other Outcomes (5)

• Changes in Self-criticism

  6 months (from Baseline to 3-months follow-up)

• Changes in Self-reassurance

  6 months (from Baseline to 3-months follow-up)

• Changes in Awareness and acceptance of experience

  6 months (from Baseline to 3-months follow-up)

Study Arms (2)

Experimental Group

EXPERIMENTAL

* Pre-treatment session + 12 Sessions Group Intervention * TAU - Treatment as usual (Psychiatric support through Public health system)

Behavioral: Dialectical Behavior Therapy - Skills

Control Group

NO INTERVENTION

* 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)

Interventions

Dialectical Behavior Therapy - Skills BEHAVIORAL

Pre-treatment session + 12 sessions DBT Skills Group (only) intervention

Also known as: Bi-REAL

Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Julieta Azevedo: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• ADEB - Associação de Apoio a Doentes Depressivos e Bipolares: collaborator
• Unidade Local de Saúde de Coimbra, EPE: collaborator
• Centro Hospitalar de Leiria: collaborator
• Centro Hospitalar do Oeste: collaborator
• University of Coimbra: collaborator
• IPM - Institute of Psychological Medicine, Faculty of Medicine, University of Coimbra: collaborator

Study Sites (1)

Faculty of Psychology and Educational Sciences - University of Coimbra

Coimbra, 3000-115, Portugal

Location

Related Publications (21)

• Azevedo, J., Macedo, A., Swales, M., & Castilho, P. (2019). A Dialectical Behaviour Therapy Skills' based intervention program for Bipolar Disorder - development of Bi-REAL. In proceedings 3ª Mostra de Doutoramento em Psicologia: - PsihDay 2019 (pp. 165-167). Coimbra; Psychologica. Accessible from https://doi.org/10.14195/1647-8606_63-1_9.

  BACKGROUND

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MeSH Terms

Conditions

Bipolar Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Julieta M Azevedo, MS

  University of Coimbra - CINEICC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student in Clinical Psychology

Model Details: 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

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 15, 2021
• Study Start: September 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: January 31, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)