Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000183886
Ethics application status
Approved
Date submitted
19/11/2020
Date registered
22/02/2021
Date last updated
22/02/2021
Date data sharing statement initially provided
22/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a peer and clinician co-facilitated group program for people with borderline personality disorder
Scientific title
Evaluation of a peer and clinician co-facilitated group program on the symptoms of borderline personality disorder- a randomised feasibility trial
Secondary ID [1] 302823 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline personality disorder 319789 0
Condition category
Condition code
Mental Health 317721 317721 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Peer Support Group Program

Materials Used: The materials used in the intervention include the facilitator manual, participant workbook, and other materials as outlined in the facilitator manual (e.g., art supplies, a whiteboard).

Procedures: The Peer Support Group Program will be based on the manual developed by the Project Air Strategy for Personality Disorders entitled Peer Support for People with Personality Disorder: A Peer and Clinician Co-Facilitated Group Intervention – Facilitator Manual (Ng et al., 2018). The group includes psychological education delivered by the peer worker and clinician, and group members sharing their experiences with one another as they feel comfortable. The intervention has been altered by the researchers to better suit a stepped down model of the peer support group following psychological therapy. Each week the topic of the program will be different.


Who will deliver intervention: The intervention will be facilitated by one peer worker and one clinician.

Content/topics covered by the peer worker and clinician facilitator: self-stigma and strengths, self-compassion and self-care, creative recovery practices, personal recovery

The mode of training used: psychological education, interactive activities

The mode of administration: Groups of 6 to 8 people

Mode of delivery: The Peer Support Group Program will be delivered face-to-face in a group setting. In the situation where COVID-19 regulations do not permit face-to-face delivery, the group will be delivered via videoconference through Zoom.

Number of times intervention will be delivered: The intervention will occur once a week for 2 hours over a period of 6 weeks.

Location: The intervention will be delivered at the University of Wollongong.

Intervention Adherence: Adherence to the intervention will be determined by a researcher and the peer worker and clinician co-facilitators using an adherence rating that was developed by the researchers, based on the Peer Support Group Program manual.
Intervention code [1] 319103 0
Treatment: Other
Comparator / control treatment
The control group will be a waitlist control which will not receive an intervention. The control group will be offered the intervention immediately after the 6-week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 325765 0
Borderline personality disorder symptoms assessed using the DSM-5 diagnostic criteria symptom count.
Timepoint [1] 325765 0
At baseline (prior to first session of peer support group program) and 6 weeks after intervention commencement
Secondary outcome [1] 389063 0
Mental health symptoms assessed using the Mental Health Inventory Five Item (MHI-5).
Timepoint [1] 389063 0
At baseline (prior to first session of peer support group program) and 6 weeks after intervention commencement

Eligibility
Key inclusion criteria
1) Person has a lived experience of borderline personality disorder (BPD)
2) Person has previously received psychological therapy
3) Person is comfortable in a group treatment setting
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Person has made a suicide attempt in the past 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by computer software, balanced by participant age, gender, and symptom severity
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Waitlist control where one group receives intervention and one group is placed on waitlist and does not receive intervention until after the intervention group is complete.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number of participants that will participate in the study is up to 120 participants which will allow statistical assumptions to be met.

Responses to clinical questions on the pre and post questionnaires will also be compared using a multilevel model with intention to treat with time as a repeated measure to investigate their response over time.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/02/2021
Actual
Date of last participant enrolment
Anticipated
22/02/2022
Actual
Date of last data collection
Anticipated
22/02/2023
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307246 0
University
Name [1] 307246 0
The Project Air Strategy for Personality Disorders, University of Wollongong
Country [1] 307246 0
Australia
Primary sponsor type
University
Name
The Project Air Strategy for Personality Disorders, University of Wollongong
Address
Northfields Clinic, Building 22.20A, Northfields Avenue, University of Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 307864 0
None
Name [1] 307864 0
Address [1] 307864 0
Country [1] 307864 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307341 0
University of Wollongong and Illawarra and Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 307341 0
Ethics committee country [1] 307341 0
Australia
Date submitted for ethics approval [1] 307341 0
Approval date [1] 307341 0
09/11/2020
Ethics approval number [1] 307341 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106898 0
Prof Brin F. S. Grenyer
Address 106898 0
University of Wollongong, Project Air Strategy | Northfields Psychology Clinic | Faculty of the Arts, Social Sciences and Humanities | School of Psychology, Building 22, Room G20A | Northfields Avenue | NSW 2522 | Wollongong | Australia
Country 106898 0
Australia
Phone 106898 0
+61 2 4221 3474
Fax 106898 0
Email 106898 0
[email protected]
Contact person for public queries
Name 106899 0
Brin F. S. Grenyer
Address 106899 0
University of Wollongong, Project Air Strategy | Northfields Psychology Clinic | Faculty of the Arts, Social Sciences and Humanities | School of Psychology, Building 22, Room G20A | Northfields Avenue | NSW 2522 | Wollongong | Australia
Country 106899 0
Australia
Phone 106899 0
+61 2 4221 3474
Fax 106899 0
Email 106899 0
[email protected]
Contact person for scientific queries
Name 106900 0
Brin F. S. Grenyer
Address 106900 0
University of Wollongong, Project Air Strategy | Northfields Psychology Clinic | Faculty of the Arts, Social Sciences and Humanities | School of Psychology, Building 22, Room G20A | Northfields Avenue | NSW 2522 | Wollongong | Australia
Country 106900 0
Australia
Phone 106900 0
+61 2 4221 3474
Fax 106900 0
Email 106900 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants will not be providing consent for data to be available in this way.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.