Evaluating the Coordinated National Implementation of DBT in Ireland

NCT ID: NCT03180541

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2018-03-31

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

Conditions

Personality Disorder, Borderline

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Dialectical Behaviour Therapy

Intervention Type: BEHAVIORAL

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Health Service Executive, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Mary Joyce

Project Co-ordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Flynn, Prof. Dip

Role: PRINCIPAL_INVESTIGATOR

Psychology Manager

References

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.

Reference Type: DERIVED

PMID: 32410670 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29482538 (View on PubMed)

Other Identifiers

NOSP 2

Identifier Type: -

Identifier Source: org_study_id