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
About this trial
This is an interventional treatment trial for Personality Disorder, Borderline
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
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
NCT ID
NCT03166579
First Posted
May 22, 2017
Last Updated
May 23, 2017
Sponsor
Health Service Executive, Ireland
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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