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Evaluating the Coordinated National Implementation of DBT in Ireland

Primary Purpose

Personality Disorder, Borderline

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Dialectical Behaviour Therapy

About this trial

This is an interventional treatment trial for Personality Disorder, Borderline

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dialectical Behaviour Therapy

Treatment-As-Usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

Change in hopelessness

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

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.

Full Information

NCT ID

NCT03180541

First Posted

May 24, 2017

Last Updated

July 2, 2018

Sponsor

Health Service Executive, Ireland

1. Study Identification

Unique Protocol Identification Number

NCT03180541

Brief Title

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

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

December 2013 (Actual)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Health Service Executive, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Personality Disorder, Borderline

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dialectical Behaviour Therapy

Arm Type

Experimental

Arm Description

Arm Title

Treatment-As-Usual

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Dialectical Behaviour Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in self-harm behaviour

Description

Time Frame

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

Title

Change in borderline symptoms

Description

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

Time Frame

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

Title

Change in suicidal ideation

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in depression

Description

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

Time Frame

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

Title

Change in hopelessness

Description

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

Time Frame

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

Title

Change in DBT Skill Use

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Flynn, Prof. Dip

Organizational Affiliation

Psychology Manager

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32410670

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.

Results Reference

derived

PubMed Identifier

29482538

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. Erratum In: BMC Psychiatry. 2018 May 7;18(1):123.

Results Reference

derived

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Evaluating the Coordinated National Implementation of DBT in Ireland

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