Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001058965
Ethics application status
Approved
Date submitted
18/06/2020
Date registered
16/10/2020
Date last updated
16/10/2020
Date data sharing statement initially provided
16/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindwise: A pilot study of a psychoeducation program for young adults who engage in non-suicidal self injury to Learn Emotional Self-Management
Scientific title
Explicit Mentalisation Psychoeducation as an Early-Intervention Tool for Young Adults who Engage in Non-Suicidal Self Injury: A Pilot Investigation
Secondary ID [1] 301526 0
None
Universal Trial Number (UTN)
U1111-1249-3505
Trial acronym
Mindwise
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Non-suicidal self-injury 317882 0
Emotional dysregulation 317883 0
Condition category
Condition code
Mental Health 315924 315924 0 0
Other mental health disorders
Injuries and Accidents 317358 317358 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants self-monitor their self harm for 3 months before the psychoeducation group starts, this serves as the control run in period. The psycho-education programme takes place over 12 weeks, with a 1.5 hour session once a week. These are group psycho-education sessions in groups of approximately 10 participants, run in person by a group facilitator, who will be an adult mental health worker who has been trained in the psychoeducation programme. The programme will cover mentalisation, self harm, and affect dysreguation, through a mix of dyadic learning and group discussion. General support, such as discussions about any material in the groups that participants found upsetting, will be available during these sessions from the group facilitator. The group facilitator will monitor adherence by attendance checklist.
Intervention code [1] 317848 0
Treatment: Other
Intervention code [2] 317849 0
Behaviour
Comparator / control treatment
this study uses a control run in periodas well as comparing with baseline measures, All participants self-monitor their self harm for 3 months before the psychoeducation group starts, this serves as the control run in period.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324152 0
self-harm characteristics, frequency, recency and severity using the NSSI-AT
Timepoint [1] 324152 0
baseline, 3 months from baseline, 6 months from baseline & 9 months from baseline. 12 week programme occurs within the 3 month and 6 month time points.
Primary outcome [2] 324153 0
any change in levels of emotional dysregulation as shown by DERS score
Timepoint [2] 324153 0
baseline, 3 months from baseline, 6 months from baseline & 9 months from baseline. 12 week programme occurs within the 3 month and 6 month time points.
Primary outcome [3] 325080 0
Daily self-record of whether participant had the urge to self-harm or engaged in self-harm each day
Timepoint [3] 325080 0
daily over all 9 months of study
Secondary outcome [1] 383880 0
any change in anxiety symptoms as measured by Beck Anxiety Inventory
Timepoint [1] 383880 0
baseline, 3 months from baseline, 6 months from baseline & 9 months from baseline. 12 week programme occurs within the 3 month and 6 month time points.
Secondary outcome [2] 383881 0
any change in ability to mentalise as measured on the mentalisation scale
Timepoint [2] 383881 0
baseline, 3 months from baseline, 6 months from baseline & 9 months from baseline. 12 week programme occurs within the 3 month and 6 month time points.
Secondary outcome [3] 386794 0
any change in depressive symptoms as measured by the Beck Depression Inventory II
Timepoint [3] 386794 0
baseline, 3 months from baseline, 6 months from baseline & 9 months from baseline. 12 week programme occurs within the 3 month and 6 month time points.
Secondary outcome [4] 386795 0
any change in borderline related traits using the SIPP-118 measure
Timepoint [4] 386795 0
baseline, 3 months from baseline, 6 months from baseline & 9 months from baseline. 12 week programme occurs within the 3 month and 6 month time points.
Secondary outcome [5] 386796 0
any change in interpersonal functioning using the IIP-28 measure
Timepoint [5] 386796 0
baseline, 3 months from baseline, 6 months from baseline & 9 months from baseline. 12 week programme occurs within the 3 month and 6 month time points.

Eligibility
Key inclusion criteria
• marked deficits in self-regulation (affect dyscontrol, impulsivity)
• moderate risk to self
• interpersonal difficulties disrupting adjustment
• willing/able to participate in programme and research
• any diagnosed mental health issues stable (ie anxiety, eating disorder, depression)
• accommodation stable
• engaging in non-suicidal self-injury, most recent episode must be within the last month.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• no major cognitive or intellectual difficulties
• no major anti-social traits (that would place others in a group at risk)
• not under Mental Health Act
• no concurrent therapy related to emotional regulation or NSSI (other therapy for targeted issues is OK; eg trauma work, anxiety, etc.)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Control run in period
repeated measures
psycho-education groups
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
one-way (time) repeated-measures analysis of variance with four levels (Baseline, pre-education group, post-education group, follow-up) with post-hoc test set to assess change over the four time periods

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2020
Actual
Date of last participant enrolment
Anticipated
29/01/2021
Actual
Date of last data collection
Anticipated
2/08/2021
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 22677 0
New Zealand
State/province [1] 22677 0
Canterbury

Funding & Sponsors
Funding source category [1] 305967 0
University
Name [1] 305967 0
University of Canterbury
Country [1] 305967 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Department of Psychology, Speech & Hearing
University Drive
Christchurch 8041
New Zealand
Country
New Zealand
Secondary sponsor category [1] 307250 0
None
Name [1] 307250 0
Address [1] 307250 0
Country [1] 307250 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306207 0
HDEC New Zealand Health and disabilities ethics committee
Ethics committee address [1] 306207 0
Ethics committee country [1] 306207 0
New Zealand
Date submitted for ethics approval [1] 306207 0
10/03/2020
Approval date [1] 306207 0
03/06/2020
Ethics approval number [1] 306207 0
20/NTB/51
Ethics committee name [2] 306223 0
University of Canterbury Human Ethics Committee
Ethics committee address [2] 306223 0
Ethics committee country [2] 306223 0
New Zealand
Date submitted for ethics approval [2] 306223 0
10/03/2020
Approval date [2] 306223 0
03/06/2020
Ethics approval number [2] 306223 0
20/NTB/51

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

Contacts
Principal investigator
Name 103094 0
Miss Rebecca Lamb
Address 103094 0
School of Psychology, Speech and Hearing
University of Canterbury
Private Bag 4800
Christchurch, 8140
Country 103094 0
New Zealand
Phone 103094 0
+64 0220989799
Fax 103094 0
Email 103094 0
[email protected]
Contact person for public queries
Name 103095 0
Rebecca Lamb
Address 103095 0
School of Psychology, Speech and Hearing
University of Canterbury
Private Bag 4800
Christchurch, 8140
Country 103095 0
New Zealand
Phone 103095 0
+64 0220989799
Fax 103095 0
Email 103095 0
[email protected]
Contact person for scientific queries
Name 103096 0
Martin Dorahy
Address 103096 0
School of Psychology, Speech and Hearing
University of Canterbury
Private Bag 4800
Christchurch, 8140
Country 103096 0
New Zealand
Phone 103096 0
+64 3 3694337
Fax 103096 0
Email 103096 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


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.