ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618001687280

Ethics application status

Approved

Date submitted

13/09/2018

Date registered

12/10/2018

Date last updated

20/09/2019

Date data sharing statement initially provided

20/09/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

A Dismantling Study of Dialectical Behaviour Therapy (DBT) Skills: Investigating the Effectiveness of Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness Skills Groups

Scientific title

A Dismantling Study of Dialectical Behaviour Therapy (DBT) Skills: Investigating the Effectiveness of Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness Skills Groups in Routine Adult Public Mental Health Settings in Queensland, Australia

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1220-4343

Trial acronym

DBT

Linked study record

None

Health condition

Health condition(s) or problem(s) studied:

Borderline Personality Disorder

Condition category

Condition code

Mental Health

Psychosis and personality disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

BRIEF NAME
Dialectical Behaviour Therapy (DBT).
WHY
DBT is an efficacious treatment for reducing suicidality and nonsuicidal self-injury among patients with Borderline Personality Disorder (BPD).
WHAT
In the standard DBT model, DBT skills and strategies are taught throughout 6-12 months of weekly 2.5-hour skills groups, weekly one-hour individual therapy sessions, between-session phone coaching, and a weekly consultation group for therapists. Standard DBT consists of three modules - Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness. Distress Tolerance module is 8 weeks, Emotion Regulation Module is 10 weeks and Interpersonal Effectiveness Module is 7 weeks.
PROCEDURES
The study involves patients of three adult mental health services across five hospitals in Queensland, who have a diagnosis of BPD, and who are completing standard DBT. We will administer outcome questionnaires to participants at five time-points.
This is a controlled trial with three active arms and one control group.
Arm 1
Princess Alexandra Hospital
Logan Hospital
Arm 2
Royal Brisbane and Women's Hospital Group 1
Royal Brisbane and Women's Hospital Group 2
Note - participants are allocated to the two RBWH groups based on capacity in each group as well as client preference for group day and time (Group 1 runs on a Wednesday, Group 2 runs on a Thursday).
Arm 3
The Prince Charles Hospital
Caboolture Hospital
WHO
Psychologists, social workers and mental health nurses who have been intensively trained in delivering standard DBT.
MODE OF DELIVERY
Face-to-face
NUMBER OF TIMES
DBT is delivered twice per week for six months.
Data are collected at five time-points:
Diagnostic and suitability assessment
Time 1: prior to commencing treatment
Time 2: following completion of the first module of DBT
Time 3: following completion of the second module of DBT
Time 4: following completion of the third module of DBT.
LOCATIONS
Princess Alexandra Hospital
Logan Hospital
Royal Brisbane and Women's Hospital
The Prince Charles Hospital
Caboolture Hospital
ADHERENCE
For group DBT sessions, adherence will be measured by group facilitators monitoring their own adherence utilising eight-item adherence checklists developed for this study; and 10% of skills groups will be independently coded via live observation by an intensively trained DBT clinician.

Intervention code [1]

Behaviour

Comparator / control treatment

The control group comprises subjects on the wait-list to participate in DBT at the Royal Brisbane and Women's Hospital. This will involve standard care. For the purposes of this study, standard care varies depending upon whatever care the subject is receiving at the time of referral - this can range from no structured care, follow up support calls from the acute care team, regular sessions with a private psychologist or psychiatrist, support from an NGO, or any other combination of care. There is no restriction on the care the wait-list subjects receive, and they are not actively followed up by the RBWH. The subjects in the control group are offered the intervention when a place becomes available in one of the groups. This is usually a wait of at least 2 months, but can be up to 6 months.

Control group

Active

Outcomes

Primary outcome [1]

Distress tolerance skills as measured by the DBT Ways of Coping Checklist (DBT WoCCL)

Timepoint [1]