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Testing the efficacy of an Emotion Regulation Group Therapy for adolescent non-suicidal self-injury in Aotearoa New Zealand

A Randomised Control Trial on the effect of Emotion Regulation Group Therapy on non-suicidal self-injury in adolescent

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000668303
Enrollment
80
Registered
2017-05-09
Start date
2017-09-01
Completion date
2019-09-02
Last updated
2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Adolescent non-suicidal self-injury (NSSI), damaging one’s body without suicidal intent, is common in New Zealand and overseas. Up to half of NZ adolescents engage in NSSI once by age 18, with 20% harming themselves more frequently. Adolescents who engage in NSSI are at increased risk of a range of mental health concerns. Our research aims to assess the efficacy of an adolescent Emotion Regulation Group Therapy (ERGT) protocol developed to reduce NSSI among New Zealand primary and secondary health service clients and secondary school students. We propose running ERGT groups across a range of services, including primary health services in the community (e.g. those that cater to youth with mild to moderate mental health concerns), secondary services that cater to moderate to severe mental health issues (e.g. Child and Adolescent Mental Health Services attached to District Health Boards), and pastoral care departments in schools. ERGT was developed in the United States for adults who self-injure and have moderate to severe mental health needs (e.g. major depression, Borderline Personality Disorder, substance use disorders). Research trials have confirmed that ERGT significantly reduces NSSI among adults who self-injure, and that this reduction in NSSI behaviour is sustained over time. But we do not know whether ERGT will be effective with adolescents or whether it can be delivered successfully by a range of providers to young people across NZ. Our project aims to test its treatment potential. We propose a randomized control trial of Emotion Regulation Group Therapy (ERGT) for adolescents, in collaboration with primary and secondary health services and secondary schools. Randomised control trials are the gold standard assessment of treatment efficacy.We will randomly assign participants to one of two groups, an 'experimental' group, which will receive treatment-as-usual and ERGT, and a treatment-as-usual ‘control’ group. We will then conduct follow-up surveys to investigate whether outcomes differ across groups. Our hypothesis is that those receiving ERGT will have greater improvements in their wellbeing and greater reductions in their tendency to self-injure following completion of therapy, compared to participants receiving TAU alone. We will also compare changes in depressive and anxious symptoms, engagement in other unhealthy behaviours (e.g. substance abuse), and capacity for emotion regulation in the two groups.

Interventions

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 grou

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.

Sponsors

Marc Wilson
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
14 Years to 19 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026