NCT03180541

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

3.8 years

First QC Date

May 24, 2017

Last Update Submit

July 2, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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.

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

  • 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.

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

Secondary Outcomes (3)

  • Change in depression

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

  • Change in hopelessness

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

  • Change in DBT Skill Use

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

Study Arms (2)

Dialectical Behaviour Therapy

EXPERIMENTAL

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

Treatment-As-Usual

NO INTERVENTION

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

Interventions

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.

Dialectical Behaviour Therapy

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Daniel Flynn, Prof. Dip

    Psychology Manager

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Co-ordinator

Study Record Dates

First Submitted

May 24, 2017

First Posted

June 8, 2017

Study Start

December 1, 2013

Primary Completion

September 1, 2017

Study Completion

March 1, 2018

Last Updated

July 3, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share