Clinical trial NCT03180541: Evaluating the Coordinated National Implementation of DBT in Ireland
Official title: Evaluation of a Coordinated National Implementation of DBT in Community Mental Health Services in Ireland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Personality Disorder, Borderline
Lead sponsor: Health Service Executive, Ireland
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 210
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Change in self-harm behaviour
timeFrame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)
measure: Change in borderline symptoms
timeFrame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)
measure: Change in suicidal ideation
timeFrame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)
Secondary outcomes:
measure: Change in depression
timeFrame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)
measure: Change in hopelessness
timeFrame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)
measure: Change in DBT Skill Use
timeFrame: Pre-intervention, 6 months, 12 months (post-intervention) and 18 months (6 months post-intervention)
Other outcomes:
Locations:
Study officials:
affiliation: Psychology Manager
name: Daniel Flynn, Prof. Dip
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.