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Effectiveness Evaluation of 'The Endeavour Programme'

Primary Purpose

Personality Disorder, Borderline

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dialectical Behaviour Therapy
Sponsored by
Health Service Executive, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Personality Disorder, Borderline

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Dialectical Behaviour Therapy

    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.

    Outcomes

    Primary Outcome Measures

    Borderline Symptoms
    Borderline Symptom List (BSL-23). The BSL-23 is a self-report questionnaire which comprises 23 items measuring borderline-typical symptomatology.
    Suicidal ideation
    Beck Scale for Suicide Ideation (BSS). The BSS is a 21-item self-report assessment developed to identify individuals at risk of suicide.
    Hopelessness
    Beck Hopelessness Scale (BHS). The BHS is a 20 item self-report measure which assesses key aspects of hopelessness.
    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.
    Anxiety
    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
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    May 22, 2017
    Last Updated
    May 23, 2017
    Sponsor
    Health Service Executive, Ireland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03166579
    Brief Title
    Effectiveness Evaluation of 'The Endeavour Programme'
    Official Title
    Evaluating the Effectiveness of 'The Endeavour Programme': DBT for Irish Adults With Borderline Personality Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (Actual)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    August 2016 (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
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    71 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dialectical Behaviour Therapy
    Arm Type
    Experimental
    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.
    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
    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
    12 months from pre-intervention to post-intervention
    Title
    Suicidal ideation
    Description
    Beck Scale for Suicide Ideation (BSS). The BSS is a 21-item self-report assessment developed to identify individuals at risk of suicide.
    Time Frame
    12 months from pre-intervention to post-intervention
    Title
    Hopelessness
    Description
    Beck Hopelessness Scale (BHS). The BHS is a 20 item self-report measure which assesses key aspects of hopelessness.
    Time Frame
    12 months from pre-intervention to post-intervention
    Title
    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
    12 months from pre-intervention to post-intervention
    Title
    Anxiety
    Description
    Beck Anxiety Inventory (BAI). The BAI is a 21 is self-report multiple choice survey which evaluates both physiological and cognitive symptoms of anxiety
    Time Frame
    12 months from pre-intervention to post-intervention
    Title
    Quality of Life
    Description
    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).
    Time Frame
    12 months from pre-intervention to post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Flynn, PGDip
    Organizational Affiliation
    Psychology Manager
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28989706
    Citation
    Flynn D, Kells M, Joyce M, Corcoran P, Gillespie C, Suarez C, Weihrauch M, Cotter P. Standard 12 month dialectical behaviour therapy for adults with borderline personality disorder in a public community mental health setting. Borderline Personal Disord Emot Dysregul. 2017 Sep 23;4:19. doi: 10.1186/s40479-017-0070-8. eCollection 2017.
    Results Reference
    derived

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    Effectiveness Evaluation of 'The Endeavour Programme'

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