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Bipolar DisorderBI-REALNCT04797351

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

A study testing Dialectical Behavior Therapy - Skills in people with Bipolar Disorder, run by Julieta Azevedo at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder
What is being tested?
Dialectical Behavior Therapy - Skills
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
1 sitePortugal
Study dates
1 Sep 2020to 31 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Faculty of Psychology and Educational Sciences - University of Coimbra

    Coimbra, 3000-115

Other trials in Portugal

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Dialectical Behavior Therapy - Skills
Keywords
Bipolar Disorder, DBT Skills, Recovery, Emotion Regulation
Medical subject headings
Bipolar Disorder, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialectical Behavior Therapy - SkillsBehavioural

    Also called Bi-REAL

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

Study groups in NCT04797351
Study groupRoleWhat they receive
Experimental GroupExperimental* Pre-treatment session + 12 Sessions Group Intervention * TAU - Treatment as usual (Psychiatric support through Public health system)
Receives: Behavioral: Dialectical Behavior Therapy - Skills
Control GroupNo 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sense of personal recovery

    Assessed by the Bipolar Recovery Questionnaire (scores vary from 0-3600) higher scores mean a better outcome

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

  2. Changes in quality of life

    Assessed by Quality of Life Questionnaire for Bipolar Disorder (scores from 1-60) higher scores mean a better outcome

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

Secondary outcomes (5)

  1. Changes in activation and reactivity levels

    Assessed through Multidimensional assessment of thymic states (0-200) continuum between Hypo-reactivity/Hyper-reactivity - median scores around 100 mean better outcome

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

  2. Changes in Distress Tolerance

    Assessed through Distress Tolerance Scale (1-75) - higher scores mean a better outcome

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

  3. Changes in psychopathology symptoms

    Assessed through Depression and Anxiety Stress Scale - lower scores mean a better outcome

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

  4. Changes in Rumination

    Assessed through Rumination-Reflexion Questionnaire (RRQ-10) lower scores mean a better outcome

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

  5. Changes in symptoms interference with life

    Assessed through semi-structured clinical interview for Bipolar Disorder (CIBD) lower scored mean less interference, thus better outcome

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2021
  2. Study start1 Sep 2020
  3. Primary completion30 Sep 2021
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04797351
Sponsor's protocol ID
BD/130116/2017_Pilot
Acronym
BI-REAL
Status last verified
Jul 2023
First submitted
7 Mar 2021
Last updated
18 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • DiRocco A, Liu L, Burrets M. Enhancing Dialectical Behavior Therapy for the Treatment of Bipolar Disorder. Psychiatr Q. 2020 Sep;91(3):629-654. doi: 10.1007/s11126-020-09709-6.

    PubMed 32144641

  • Balanza-Martinez V, Selva G, Martinez-Aran A, Prickaerts J, Salazar J, Gonzalez-Pinto A, Vieta E, Tabares-Seisdedos R. Neurocognition in bipolar disorders--a closer look at comorbidities and medications. Eur J Pharmacol. 2010 Jan 10;626(1):87-96. doi: 10.1016/j.ejphar.2009.10.018. Epub 2009 Oct 18.

    PubMed 19836378

  • Barnett JH, Smoller JW. The genetics of bipolar disorder. Neuroscience. 2009 Nov 24;164(1):331-43. doi: 10.1016/j.neuroscience.2009.03.080. Epub 2009 Apr 7.

    PubMed 19358880

  • Beynon S, Soares-Weiser K, Woolacott N, Duffy S, Geddes JR. Pharmacological interventions for the prevention of relapse in bipolar disorder: a systematic review of controlled trials. J Psychopharmacol. 2009 Jul;23(5):574-91. doi: 10.1177/0269881108093885. Epub 2008 Jul 17.

    PubMed 18635701

  • Cardoso Tde A, Farias Cde A, Mondin TC, da Silva Gdel G, Souza LD, da Silva RA, Pinheiro KT, do Amaral RG, Jansen K. Brief psychoeducation for bipolar disorder: impact on quality of life in young adults in a 6-month follow-up of a randomized controlled trial. Psychiatry Res. 2014 Dec 30;220(3):896-902. doi: 10.1016/j.psychres.2014.09.013. Epub 2014 Sep 28.

    PubMed 25300245

  • de Barros Pellegrinelli K, de O Costa LF, Silval KI, Dias VV, Roso MC, Bandeira M, Colom F, Moreno RA. Efficacy of psychoeducation on symptomatic and functional recovery in bipolar disorder. Acta Psychiatr Scand. 2013 Feb;127(2):153-8. doi: 10.1111/acps.12007. Epub 2012 Sep 4.

    PubMed 22943487

  • Dean BB, Gerner D, Gerner RH. A systematic review evaluating health-related quality of life, work impairment, and healthcare costs and utilization in bipolar disorder. Curr Med Res Opin. 2004;20(2):139-54. doi: 10.1185/030079903125002801.

    PubMed 15006007

  • Fowke A, Ross S, Ashcroft K. Childhood maltreatment and internalized shame in adults with a diagnosis of bipolar disorder. Clin Psychol Psychother. 2012 Sep;19(5):450-7. doi: 10.1002/cpp.752. Epub 2011 May 9.

    PubMed 21557379

  • Gama CS, Kunz M, Magalhaes PV, Kapczinski F. Staging and neuroprogression in bipolar disorder: a systematic review of the literature. Braz J Psychiatry. 2013 Mar;35(1):70-4. doi: 10.1016/j.rbp.2012.09.001.

    PubMed 23567604

  • Goldstein TR, Fersch-Podrat RK, Rivera M, Axelson DA, Merranko J, Yu H, Brent DA, Birmaher B. Dialectical behavior therapy for adolescents with bipolar disorder: results from a pilot randomized trial. J Child Adolesc Psychopharmacol. 2015 Mar;25(2):140-9. doi: 10.1089/cap.2013.0145. Epub 2014 Jul 10.

    PubMed 25010702

  • Van Dijk S, Jeffrey J, Katz MR. A randomized, controlled, pilot study of dialectical behavior therapy skills in a psychoeducational group for individuals with bipolar disorder. J Affect Disord. 2013 Mar 5;145(3):386-93. doi: 10.1016/j.jad.2012.05.054. Epub 2012 Aug 1.

    PubMed 22858264

  • Gomes BC, Abreu LN, Brietzke E, Caetano SC, Kleinman A, Nery FG, Lafer B. A randomized controlled trial of cognitive behavioral group therapy for bipolar disorder. Psychother Psychosom. 2011;80(3):144-50. doi: 10.1159/000320738. Epub 2011 Mar 3.

    PubMed 21372622

  • Goodwin GM, Haddad PM, Ferrier IN, Aronson JK, Barnes T, Cipriani A, Coghill DR, Fazel S, Geddes JR, Grunze H, Holmes EA, Howes O, Hudson S, Hunt N, Jones I, Macmillan IC, McAllister-Williams H, Miklowitz DR, Morriss R, Munafo M, Paton C, Saharkian BJ, Saunders K, Sinclair J, Taylor D, Vieta E, Young AH. Evidence-based guidelines for treating bipolar disorder: Revised third edition recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2016 Jun;30(6):495-553. doi: 10.1177/0269881116636545. Epub 2016 Mar 15.

    PubMed 26979387

  • Salcedo S, Gold AK, Sheikh S, Marcus PH, Nierenberg AA, Deckersbach T, Sylvia LG. Empirically supported psychosocial interventions for bipolar disorder: Current state of the research. J Affect Disord. 2016 Sep 1;201:203-14. doi: 10.1016/j.jad.2016.05.018. Epub 2016 May 14.

    PubMed 27243619

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical Behavior Therapy - Skills in people with Bipolar Disorder, run by Julieta Azevedo at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sense of personal recovery (time frame: 6 months (from Baseline to 3-months follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04797351, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.

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