CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
Dialectical Behavior Therapy - Skillsbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04797351
NCT04797351N/ACompleted

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

Julieta Azevedo·interventional·Posted Mar 15, 2021·Updated Jul 18, 2023

In Brief

A clinical study evaluating Dialectical Behavior Therapy - Skills for Bipolar Disorder. Completed, enrolled 109 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 15, 2021
Enrollment StartSep 1, 2020
Primary CompletionSep 30, 2021
Study CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.3 years ago

Interventions

Dialectical Behavior Therapy - Skillsbehavioral

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