## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** NOSP
#### Organization
**Class:** OTHER
**Full Name:** Health Service Executive, Ireland
### Status Module
#### Completion Date
**Date:** 2016-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-05-25

**Type:** ACTUAL

**Last Update Submit Date:** 2017-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-08

**Type:** ACTUAL

#### Start Date
**Date:** 2010-07

**Type:** ACTUAL

**Status Verified Date:** 2017-05

#### Study First Post Date
**Date:** 2017-05-25
**Type:** ACTUAL
**Study First Submit Date:** 2017-05-22
**Study First Submit QC Date:** 2017-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Health Service Executive, Ireland

#### Responsible Party

**Investigator Affiliation:** Health Service Executive, Ireland

**Investigator Full Name:** Mary Joyce

**Investigator Title:** Project Co-ordinator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Personality Disorder, Borderline

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 71

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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 Names:**

- Behavioral: Dialectical Behaviour Therapy

**Label:** Dialectical Behaviour Therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dialectical Behaviour Therapy

**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.

**Name:** Dialectical Behaviour Therapy

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Borderline Symptom List (BSL-23). The BSL-23 is a self-report questionnaire which comprises 23 items measuring borderline-typical symptomatology.

**Measure:** Borderline Symptoms

**Time Frame:** 12 months from pre-intervention to post-intervention

**Description:** Beck Scale for Suicide Ideation (BSS). The BSS is a 21-item self-report assessment developed to identify individuals at risk of suicide.

**Measure:** Suicidal ideation

**Time Frame:** 12 months from pre-intervention to post-intervention

**Description:** Beck Hopelessness Scale (BHS). The BHS is a 20 item self-report measure which assesses key aspects of hopelessness.

**Measure:** Hopelessness

**Time Frame:** 12 months from pre-intervention to post-intervention

**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.

**Measure:** Depression

**Time Frame:** 12 months from pre-intervention to post-intervention

**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

**Measure:** Anxiety

**Time Frame:** 12 months from pre-intervention to post-intervention

**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).

**Measure:** Quality of Life

**Time Frame:** 12 months from pre-intervention to post-intervention

### Eligibility Module

**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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Psychology Manager

**Name:** Daniel Flynn, PGDip

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 28989706

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13462

- Name: Personality Disorders

- Relevance: HIGH

- As Found: Personality Disorder

- ID: M5161

- Name: Borderline Personality Disorder

- Relevance: HIGH

- As Found: Personality Disorder, Borderline

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010554

- Term: Personality Disorders

- ID: D000001883

- Term: Borderline Personality Disorder

### Misc Info Module

- Version Holder: 2024-05-24
