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Evaluating the Coordinated National Implementation of DBT in Ireland

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ClinicalTrials.gov Identifier: NCT03180541
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Mary Joyce, Health Service Executive, Ireland

Brief 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 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

Condition or disease Intervention/treatment Phase
Personality Disorder, Borderline Behavioral: Dialectical Behaviour Therapy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Coordinated National Implementation of DBT in Community Mental Health Services in Ireland
Actual Study Start Date : December 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dialectical Behaviour Therapy
Participants 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
Behavioral: Dialectical Behaviour Therapy
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.

No Intervention: Treatment-As-Usual

The 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



Primary Outcome Measures :
  1. Change in self-harm behaviour [ Time Frame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention) ]
    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.

  2. Change in borderline symptoms [ Time Frame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention) ]
    Borderline Symptom List (BSL-23). The BSL-23 is a self-report questionnaire which comprises 23 items measuring borderline-typical symptomatology.

  3. Change in suicidal ideation [ Time Frame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention) ]
    Questionnaire for Suicidal Ideation (QSI). The QSI is a 6-item self-report questionnaire developed by the researchers to assess suicidal thoughts and ideation.


Secondary Outcome Measures :
  1. Change in depression [ Time Frame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention) ]
    Beck Depression Inventory - Second Edition (BDI-II). The BDI-II is a 21 item self-report measure of symptoms and attitudes related to depression.

  2. Change in hopelessness [ Time Frame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention) ]
    Beck Hopelessness Scale (BHS). The BHS is a 20 item self-report measure which assesses key aspects of hopelessness.

  3. Change in DBT Skill Use [ Time Frame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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
  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180541


Sponsors and Collaborators
Health Service Executive, Ireland
Investigators
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Principal Investigator: Daniel Flynn, Prof. Dip Psychology Manager
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mary Joyce, Project Co-ordinator, Health Service Executive, Ireland
ClinicalTrials.gov Identifier: NCT03180541    
Other Study ID Numbers: NOSP 2
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders