Effectiveness Evaluation of 'The Endeavour Programme'

Not Applicable

Completed

• Conditions: Personality Disorder, Borderline
• Interventions: Behavioral: Dialectical Behaviour Therapy

• Registration Number: NCT03166579
• Lead Sponsor: Health Service Executive, Ireland

Brief Summary

This study aims to evaluate the effectiveness of Dialectical Behaviour Therapy for adults with Borderline Personality Disorder attending Community Mental Health Services in Cork, Ireland.

The main objective of the current study is to determine if completion of a 12 month DBT programme is associated with improved outcomes in terms of borderline symptoms, anxiety, hopelessness, suicidal behaviour, depression and quality of life.

A secondary objective includes assessing client progress across multiple time-points throughout the treatment.

Detailed Description

Dialectical Behaviour Therapy (DBT) is noted to be an intervention with a growing evidence base which demonstrates its effectiveness in treating individuals with Borderline Personality Disorder (BPD). Nine randomised controlled trials have been completed at six independent sites. These trials have found a reduction in suicidal behaviours, intentional self-injury, depression, hopelessness and other difficulties associated with this mental health diagnosis.

While the efficacy of DBT has been demonstrated through multiple RCTs, few studies have examined the effectiveness of DBT in community mental health settings. In particular, no study to our knowledge has evaluated the standard 12-month DBT programme for adults with BPD in an Irish community setting. "Standard" 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.

The current study thus aims to evaluate the effectiveness of the standard 12-month DBT programme (The Endeavour Programme) in an Irish community setting.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-05
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-23
• Last Update Submitted: 2017-05-23
• Study First Posted: 2017-05-25
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Meet criteria for diagnosis of either Borderline Personality Disorder (DSM IV/V) or Emotionally Unstable Personality Disorder (ICD-10)
• Current emotion and behavioural dysregulation
• A history of self-harm behaviour
• The client 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dialectical Behaviour Therapy	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.

Primary Outcome Measures

Name	Time	Method
Hopelessness	12 months from pre-intervention to post-intervention	Beck Hopelessness Scale (BHS). The BHS is a 20 item self-report measure which assesses key aspects of hopelessness.
Anxiety	12 months from pre-intervention to post-intervention	Beck Anxiety Inventory (BAI). The BAI is a 21 is self-report multiple choice survey which evaluates both physiological and cognitive symptoms of anxiety
Quality of Life	12 months from pre-intervention to post-intervention	World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF). The WHOQOL-BREF was developed collaboratively in a number of centres to act as an international cross-culturally comparable quality of life assessment. It comprises 26 items across four domains: physical health (domain 1), psychological health (domain 2), social relationships (domain 3), and environment (domain 4).
Borderline Symptoms	12 months from pre-intervention to post-intervention	Borderline Symptom List (BSL-23). The BSL-23 is a self-report questionnaire which comprises 23 items measuring borderline-typical symptomatology.
Suicidal ideation	12 months from pre-intervention to post-intervention	Beck Scale for Suicide Ideation (BSS). The BSS is a 21-item self-report assessment developed to identify individuals at risk of suicide.
Depression	12 months from pre-intervention to 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.