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
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|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Principal Investigator:||Daniel Flynn, Prof. Dip||Psychology Manager|