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Personality Disorder, BorderlineNCT03180541

Evaluating the Coordinated National Implementation of DBT in Ireland

A study testing Dialectical Behaviour Therapy in people with Personality Disorder, Borderline, run by Health Service Executive, Ireland.

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

This study aims to evaluate the coordinated implementation of Dialectical Behaviour Therapy in Community Mental Health Services in Ireland. There are three main objectives of the current study: evaluate the effectiveness of DBT for adults and adolescents attending Community Mental Health Services in multiple sites… Read more about this study

Who is it for?
Ages 13 years and olderHealthy volunteers can take part
Conditions the study is for
Personality Disorder, Borderline
What is being tested?
Dialectical Behaviour Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
No sites listed yet
Study dates
Dec 2013to Mar 2018
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 13 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Adults:
  • Meet criteria for diagnosis of either Borderline Personality Disorder (DSM IV/V) or Emotionally Unstable Personality Disorder (ICD-10)
  • A persistent pattern of deliberate self-harm with deliberate self-harm behaviour having occurred within the last 6 months OR one suicidal act having occurred within the last 6 months
  • The individual will have discussed the diagnosis with a member of the DBT team and will have expressed an interest in, and commitment to the 12 month programme.
  • Adolescents:
  • Between/ including the ages of 13 and 18 years
Show all 9Show fewer
  • Demonstrating emotional behavioural disturbance/ emotional dysregulation
  • A persistent pattern of deliberate self-harm with deliberate self-harm or a suicidal act having occurred within the last 16 weeks OR chronic suicidal ideation
  • the young person and their parent/guardian will have discussed their emotional behavioural disturbance/ emotional dysregulation with a member of the DBT team and will have expressed an interest in, and commitment to the 16 week programme.

Who cannot join

  • Adults and Adolescents:
  • An active psychosis
  • If the client has severe developmental delays, cognitive impairment or learning disabilities (exceeding mild range)
  • If a clients' substance/drug dependence, eating disorder or any other mental health issue/behaviour is at such a level that it would impede their engaging with any of the modalities of DBT

About this study

Official title: Evaluation of a Coordinated National Implementation of DBT in Community Mental Health Services in Ireland

This study aims to evaluate the coordinated implementation of Dialectical Behaviour Therapy in Community Mental Health Services in Ireland.

There are three main objectives of the current study:

  • evaluate the effectiveness of DBT for adults and adolescents attending Community Mental Health Services in multiple sites across Ireland
  • conduct an economic evaluation of the coordinated implementation of DBT in community settings in Ireland
  • evaluate the implementation initiative by means of quantity, quality and experience of the coordinated implementation
Read the detailed description

The National Dialectical Behaviour Therapy (DBT) Project, Ireland was established in the Republic of Ireland in 2013. The aims of the project were twofold: to implement DBT in Community Mental Health Services across Ireland and to evaluate this coordinated implementation of DBT at a national level.

DBT was initially formulated as a treatment for Borderline Personality Disorder (BPD) which is typically characterised by patterns of emotional and behavioural dysregulation that often manifests in self-harm and suicidal ideation. DBT is noted to be an intervention with a growing evidence base that demonstrates its effectiveness in treating individuals with BPD. More than a dozen controlled trials have been completed at multiple independent sites. The results of these trials have reported a reduction in suicidal behaviours, inpatient hospitalisations, depression, hopelessness and suicidal ideation among other constructs which individuals with BPD experience.

While the efficacy of DBT has been demonstrated through multiple controlled trials, few studies have examined the effectiveness of DBT in community mental health settings. In particular, no study has evaluated a coordinated national implementation of DBT across multiple sites in a publicly funded health system. The current study aims to evaluate the the coordinated implementation of DBT in Community Mental Health Services in Ireland

Being tested
Dialectical Behaviour Therapy
Medical subject headings
Borderline Personality Disorder

What participants receive

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

  • Dialectical Behaviour TherapyBehavioural

    Dialectical Behaviour Therapy (DBT) is a psychological intervention which was originally developed for women with Borderline Personality Disorder. DBT is delivered by a team of multidisciplinary mental health professionals, and comprises of individual therapy sessions for each patient, group skills training sessions, phone coaching and consultation meetings for the clinicians on the DBT team. Group skills are delivered in blocks of three modules which teach mindfulness, distress tolerance, emotion regulation and interpersonal effectiveness. The three modules are delivered over a 24-week period and are then repeated.

Study groups in NCT03180541
Study groupRoleWhat they receive
Dialectical Behaviour TherapyExperimentalParticipants receive the "standard" 12 month DBT programme where all four modes of treatment are delivered including: individual therapy, group skills training, telephone coaching and DBT team consultation
Receives: Behavioral: Dialectical Behaviour Therapy
Treatment-As-UsualNo interventionThe Treatment-As-Usual arm will include individuals who: * live in areas where no DBT intervention is currently available OR * were offered a place on the DBT programme but decided not to partake at that time

What is being measured

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

  1. Change in self-harm behaviour

    Change in frequency of self-harm behaviour. Frequency of self-harm behaviour for a six month period will be recorded by the DBT therapist working with each individual by means of clinical file review. Self-harm behaviour frequency is scored on a scale of 1 to 5 where 1 = Not at all, 2 = Rarely; 3 = Occasionally, 4 = Often, 5 = Most of the time.

    Measured: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)

  2. Change in borderline symptoms

    Borderline Symptom List (BSL-23). The BSL-23 is a self-report questionnaire which comprises 23 items measuring borderline-typical symptomatology.

    Measured: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)

  3. Change in suicidal ideation

    Questionnaire for Suicidal Ideation (QSI). The QSI is a 6-item self-report questionnaire developed by the researchers to assess suicidal thoughts and ideation.

    Measured: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)

Secondary outcomes (3)

  1. Change in depression

    Beck Depression Inventory - Second Edition (BDI-II). The BDI-II is a 21 item self-report measure of symptoms and attitudes related to depression.

    Measured: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)

  2. Change in hopelessness

    Beck Hopelessness Scale (BHS). The BHS is a 20 item self-report measure which assesses key aspects of hopelessness.

    Measured: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)

  3. Change in DBT Skill Use

    DBT Ways of Coping Checklist (DBT-WCCL). The DBT-WCCL is a 59-item self-report measure which assesses DBT skill use and dysfunctional coping.

    Measured: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)

Timeline

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

  1. First posted8 Jun 2017
  2. Study startDec 2013
  3. Primary completionSep 2017
  4. Study completionMar 2018

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03180541
Sponsor's protocol ID
NOSP 2
Status last verified
Jul 2018
First submitted
24 May 2017
Last updated
3 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Flynn D, Joyce M, Gillespie C, Kells M, Swales M, Spillane A, Hurley J, Hayes A, Gallagher E, Arensman E, Weihrauch M. Evaluating the national multisite implementation of dialectical behaviour therapy in a community setting: a mixed methods approach. BMC Psychiatry. 2020 May 14;20(1):235. doi: 10.1186/s12888-020-02610-3.

    PubMed 32410670

  • Flynn D, Kells M, Joyce M, Suarez C, Gillespie C. Dialectical behaviour therapy for treating adults and adolescents with emotional and behavioural dysregulation: study protocol of a coordinated implementation in a publicly funded health service. BMC Psychiatry. 2018 Feb 26;18(1):51. doi: 10.1186/s12888-018-1627-9.

    PubMed 29482538

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical Behaviour Therapy in people with Personality Disorder, Borderline, run by Health Service Executive, Ireland.

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 9 inclusion and 4 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 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Change in self-harm behaviour (time frame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)). The study lists 3 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 NCT03180541, which also lists 2 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 3 Jul 2018.

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