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

NCT04797351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2023-07-18

No results posted yet for this study

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

Interventions

BEHAVIORAL

Dialectical Behavior Therapy - Skills

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

Sponsors & Collaborators

  • Fundação para a Ciência e a Tecnologia

    collaborator OTHER
  • ADEB - Associação de Apoio a Doentes Depressivos e Bipolares

    collaborator UNKNOWN
  • Unidade Local de Saúde de Coimbra, EPE

    collaborator OTHER
  • Centro Hospitalar de Leiria

    collaborator OTHER
  • Centro Hospitalar do Oeste

    collaborator OTHER
  • University of Coimbra

    collaborator OTHER
  • IPM - Institute of Psychological Medicine, Faculty of Medicine, University of Coimbra

    collaborator UNKNOWN
  • Julieta Azevedo

    lead OTHER

Principal Investigators

  • Julieta M Azevedo, MS · University of Coimbra - CINEICC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-09-30
Completion
2022-01-31

Countries

  • Portugal

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04797351 on ClinicalTrials.gov