Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000668303p
Ethics application status
Not yet submitted
Date submitted
1/05/2017
Date registered
9/05/2017
Date last updated
9/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the efficacy of an Emotion Regulation Group Therapy for adolescent non-suicidal self-injury in Aotearoa New Zealand
Scientific title
A Randomised Control Trial on the effect of Emotion Regulation Group Therapy on non-suicidal self-injury in adolescent
Secondary ID [1] 291762 0
Nil known
Universal Trial Number (UTN)
U1111-1190-5820
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-suicidal self-injury (NSSI) 302988 0
Emotion Regulation 302989 0
Condition category
Condition code
Mental Health 302453 302453 0 0
Other mental health disorders
Injuries and Accidents 302621 302621 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised control trial (RCT) aims to assess the effectiveness of Emotion Regulation Group therapy (ERGT) in reducing non-suicidal self-injury among adolescents in primary and secondary health services, and secondary school pastoral care, as an adjunct to treatment as usual (TAU). Non-suicidal self-injury (NSSI: direct and deliberate destruction of body tissue) will be the main outcome variable under study. Participants will be randomly allocated either into the TAU condition (control group), or TAU plus ERGT (experimental group). We aim to test the hypothesis that participants in the experimental condition will have significantly greater reductions in their NSSI compared to participants in the control group, over the course of therapy and the follow-up period. Questionnaire data will be collected from participants, their families and clinicians pre-, post- and at follow-up intervals regarding their well being, emotion regulation capacity and self-injury, to assess changes over time.

ERGT was originally developed by Kim Gratz and Matthew Tull, to reduce self-injury among adults with significant mental health problems. We have adapted ERGT slightly, for adolescents in New Zealand. Gratz and Tull are collaborating on this project, and will assist with maintaining treatment fidelity, but providing supervision, and reviewing our amended ERGT materials. This will ensure that the project team are adhering to the original tenants of ERGT. Where possible, ERGT sessions will be recorded, and these recordings reviewed during supervision. to assess adherence to the concepts of ERGT. ERGT clinicians will have regular meetings to review their practice.

Materials used in the study include a therapy manual, treatment booklet for participants in the experimental group (with ERGT materials and homework exercise), and questionnaires for the collection of data.

ERGT involves weekly sessions of group therapy, over a period of 14 weeks. Specifically, there will be 14 weekly sessions; one session per week for 14 weeks. Each session is 90 minutes long. Homework will be assigned each week. The homework will take approximately 20 minutes every week. Intervention will occur at multiple locations, including secondary mental health services (i.e. Child and Adolescent Mental Health Services, CAMHS), primary mental health services (e.g. Evolve in Wellington, a youth health and support agency), and secondary schools, in the Wellington region.

Two facilitators will conduct each group, with 6 - 8 participants in a group. Facilitators will be trained in providing psychological treatment to mental health clients, and have a background or some experience in either Dialectical Behaviour Therapy or Acceptance and Commitment Therapy. At least one of the two facilitators of each ERGT group will be trained in ERGT, either at an ERGT training provided by Gratz and Tull, or training provided by the lead clinicians on the research team (Garisch and O'Connell).

ERGT training will be run over 3 days. The training resources will include the treatment manual (which will be reviewed), including the client worksheets, and videos of either recorded sessions (with client consent) or videos of mock-ERGT sessions developed for the purposes of training. The training will be delivered face-to-face, and provided in a group setting (attendees will likely come for a range of service backgrounds, including primary and secondary services, and secondary schools). The three day training will occur over three consecutive days, from 9am - 5pm each day. Training will occur well in advance of the start of the intervention.

ERGT is aimed at developing clients' emotion regulation capacity. ERGT is aimed at helping clients respond to their emotions in more helpful ways, and learning to better understand the functions of emotions and what information may be gleaned from their emotional experience. The treatment includes psychoeducation regarding emotions, and goes through strategies to enable more healthy responses to emotions. Self-injury and its antecedents and consequences are discussed, as a way to determine what emotions may trigger self-injury, and how these emotional experiences and needs can be met in a healthier way. The later part of the group involves values work, and encouraging clients to act and make decisions in accordance with their values and goals, rather than fall into unhelpful responses to manage their emotional distress.

Treatment as usual will be varied. All participants will need to be engaged in face-to-face work with a case manager or individual clinician. All ERGT participants will be engaged in TAU alongside completing ERGT, The ERGT group is a skills group, not a process group. All issues regarding process, and risk, will be managed by participants ordinary clinician and treatment team.

Participants in the experimental group will also receive Treatment as Usual (TAU). We are testing whether ERGT improves reductions in NSSI over and above TAU alone. TAU is likely to be varied, and depend on the treatment site, severity of presentation, and the training background of participants' individual clinician or case manager. TAU is likely to include Cognitive Behavioural Therapy (CBT), treatment that includes components of Dialectical Behavioural Therapy (DBT) (i.e. DBT skills taught in individual face-to-face sessions), Acceptance and Commitment Therapy, and psychotherapy. TAU may also include a family therapy component, or psychological support for a primary caregiver (e.g. to assist in their response to their child's mental health concerns).

TAU will continue for as long as required under treatment sites usual protocol (i.e. ordinarily until a client shows substantial benefit to no longer need service intervention, or until a participant or their family self-selects to discontinue treatment). The research study will follow participants for a minimum of 12 - 18 months, to enable to collection of follow-up data.

Please note that this trial is in the early stages. Several factors may vary once initial groups have been conducted to 'pilot' ERGT in this population and check feasibility. For example, we may reduce the number of ERGT sessions, as the adult materials will be made shorter and less cognitively taxing, which may lead to less time needed to administer the skills group.
Intervention code [1] 297875 0
Behaviour
Intervention code [2] 297876 0
Treatment: Other
Comparator / control treatment
The control treatment will be a form of psychological intervention for non-suicidal self-injury and comorbid conditions among adolescent users of primary and secondary mental health services, and secondary school pastoral care. This treatment is likely to be variable, depending on the treatment site, the severity of each participant's mental health presentation (which will likely determine treatment intensity), and the training background of the treating individual clinician or case manager. Treatment is likely to include CBT, DBT- based therapy, ACT, and psychotherapy. Treating clinicians will come from a range of training backgrounds including: clinical psychologists, social workers, psychiatrists, mental health nurses, family therapists, and psychotherapists.

TAU will continue for as long as required under treatment sites usual protocol (i.e. ordinarily until a client shows substantial benefit to no longer need service intervention, or until a participant or their family self-selects to discontinue treatment). The research study will follow participants for a minimum of 12 - 18 months, to enable to collection of follow-up data.
Control group
Active

Outcomes
Primary outcome [1] 301865 0
Changes in self-reported non-suicidal self-injury behaviour, as measured by the Deliberate Self-Harm Inventory - 9 item version (DSHI-9; Lundh et al., 2007).
Timepoint [1] 301865 0
Measured at start of treatment/engagement in trial; at weekly intervals during ERGT, post-ERGT group (week 15), and at 3-, 6- and 12-month follow-up for all participants
Primary outcome [2] 301866 0
Changes in self-reported emotion regulation as measured by the Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Timepoint [2] 301866 0
Measured at the start of treatment/engagement in the trial, weekly during ERGT group, post-ERGT group (week 15), and at 3-, 6- and 12- month follow-up for all participants.
Secondary outcome [1] 334153 0
Medical intervention needed for NSSI behaviour as measured by participant, family or clinician self-report. This includes going to a doctor, nurse, or medical centre or hospital to address NSSI.
Timepoint [1] 334153 0
Measured at the beginning of treatment, weekly during the course of ERGT group, and at 3-, 6- and 12 month follow-up.
Secondary outcome [2] 334564 0
Depressive symptoms (Measured using the Depression, Anxiety and Stress Scales (DASS); Lovibond & Lovibond, 1995).
Timepoint [2] 334564 0
Measured at the beginning of treatment, weekly during the course of ERGT group, and at 3-, 6- and 12 month follow-up.
Secondary outcome [3] 334565 0
Anxious symptoms (measured using the Depression, Anxiety and Stress Scale (DASS); Lovibond & Lovibond, 1995)
Timepoint [3] 334565 0
Measured at the beginning of treatment, weekly during the course of ERGT group, and at 3-, 6- and 12 month follow-up.
Secondary outcome [4] 334566 0
Alcohol and Substance abuse and risky behaviours associated with misuse (measured using the CRAFFT)
Timepoint [4] 334566 0
Measured at the beginning of treatment, weekly during the course of ERGT group, and at 3-, 6- and 12 month follow-up.

Eligibility
Key inclusion criteria
Intake criteria: Aged 14 - 19 years, current or recent NSSI, willingness to reduce self-injury, 3+ episodes of NSSI in the past year. engaged in treatment with an individual clinician, commitment to staying engaged in treatment.
Minimum age
14 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Autistic Spectrum Disorder, intellectual disability, patients unwilling to address their NSSI, engagement in another group therapy, engagement in another research trial, active psychosis, undergoing changes in medication, parents/caregiver unable to support them to attend therapy, actively suicidal requiring inpatient or residential care.

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 concealed (by central randomisation by phone/fax/computer)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analysis indicates that identifying a significant effect of ERGT equivalent to a reduction of one self-injury episode in a given evaluation period requires at least two groups of 32 participants each (total of 64 participants or more)20. We anticipate 40-48 ERGT participants and 40-48 matched controls (totalling 80–96 participants) over a 24-month period. The number of participants will depend on funding. Currently we are awaiting outcome(s) of funding applications. If funding is limited, the trial is likely to occur over an extended period as funds and clinician time will be sparse.

Our methods of data analysis will be varied. We will conduct statistical analyses to determine group-level differences between the ERGT and TAU groups, and anticipate conducting multivariate analyses. If sample size allows, we will investigate variation in treatment effects based on treatment site location and/or client demographics (e.g. whether participants are attending primary or secondary services for individual therapy). We will also conduct focsu groups or interviews with participants who complete ERGT, to gain insight into participants' engagement with the ERGT materials, and the experience of participating in this research. We anticipate using content analysis and thematic analysis in regards to our qualitative data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2017
Actual
Date of last participant enrolment
Anticipated
2/09/2019
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 8841 0
New Zealand
State/province [1] 8841 0

Funding & Sponsors
Funding source category [1] 296264 0
Other Collaborative groups
Name [1] 296264 0
Secondary services (e.g. CAMHS)
Country [1] 296264 0
New Zealand
Funding source category [2] 296385 0
Other Collaborative groups
Name [2] 296385 0
Primary Services
Country [2] 296385 0
New Zealand
Funding source category [3] 296386 0
Other Collaborative groups
Name [3] 296386 0
Secondary schools in the Wellington region
Country [3] 296386 0
New Zealand
Primary sponsor type
Individual
Name
Marc Wilson
Address
School of Psychology, Victoria University of Wellington, Kelburn Parade, Kelburn, PO Box 600, Wellington, 6140, New Zealand
Country
New Zealand
Secondary sponsor category [1] 295179 0
Individual
Name [1] 295179 0
Jessica Garisch
Address [1] 295179 0
School of Psychology, Victoria University of Wellington, Kelburn Parade, Kelburn, PO Box 600, Wellington, 6140, New Zealand
Country [1] 295179 0
New Zealand
Other collaborator category [1] 279537 0
University
Name [1] 279537 0
Victoria University of Wellington
Address [1] 279537 0
School of Psychology, Victoria University of Wellington, Kelburn Parade, Kelburn, PO Box 600, Wellington, 6140, New Zealand
Country [1] 279537 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 297499 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 297499 0
Ethics committee country [1] 297499 0
New Zealand
Date submitted for ethics approval [1] 297499 0
11/05/2017
Approval date [1] 297499 0
Ethics approval number [1] 297499 0

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

Contacts
Principal investigator
Name 74234 0
Prof Marc Wilson
Address 74234 0
School of Psychology
Victoria University of Wellington
Kelburn Parade
PO Box 600
Wellington 6012
New Zealand
Country 74234 0
New Zealand
Phone 74234 0
+64 4 463 5225
Fax 74234 0
Email 74234 0
[email protected]
Contact person for public queries
Name 74235 0
Jessica Garisch
Address 74235 0
School of Psychology
Victoria University of Wellington
Kelburn Parade
PO Box 600
Wellington 6012
New Zealand
Country 74235 0
New Zealand
Phone 74235 0
+ 64 4 463 9657
Fax 74235 0
Email 74235 0
[email protected]
Contact person for scientific queries
Name 74236 0
Marc Wilson
Address 74236 0
School of Psychology
Victoria University of Wellington
Kelburn Parade
PO Box 600
Wellington 6012
New Zealand
Country 74236 0
New Zealand
Phone 74236 0
+ 64 4 463 5225
Fax 74236 0
Email 74236 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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