Nonsuicidal Self Injury, Nonsuicidal Self-Injury, Self-Harm
Conditions
Keywords
Nonsuicidal self-injury, Self-harm, Psychological treatment, Adolescence
Brief summary
The overarching aim of this study is to develop and evaluate a new blended treatment format, which combines face-to-face and digital treatment components, for Emotion Regulation Individual Therapy for Adolescents (ERITA). This brief, transdiagnostic, and blended treatment targeting nonsuicidal self-injury (NSSI) - referred to as blended ERITA - will be specifically designed for adolescents with NSSI and low levels of functioning within intensive outpatient psychiatric services. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.
Detailed description
NSSI is a growing health crisis among youth and the strongest risk factor for suicide attempts. Scalable and evidence-based treatments are needed but lacking. We have recently shown that a brief digital treatment, Internet-delivered ERITA, can be efficacious compared to treatment as usual only. However, digital treatment is not suitable for everyone. Adolescents with low levels of functioning have trouble engaging in text-based therapy independently from home. A blended format, which combines in-person and online treatment, may enhance effectiveness; therapists can tailor delivery of material, and adolescents can access the skills when necessary. This project aims to develop and evaluate a blended version of ERITA - blended ERITA - for adolescents with low levels of functioning. The specific objectives of this pilot study are: Primary: * Evaluate the feasibility of the project (i.e., data proportion at the primary endpoint, adherence, treatment completion, and therapist time) * Evaluate acceptability of blended ERITA (i.e., satisfaction, credibility, negative effects) Secondary: \- Provide explorative data on the utility of blended ERITA and treatment as usual. This project is sponsored by the Swedish Research Council for Health, Working life, and Welfare (number 2025-01507). The protocol including statistical analysis plan is found at: https://osf.io/e6wjq/overview
Interventions
BEHAVIORALBlended ERITA
Blended ERITA is an acceptance-based behavioral therapy. The goal of ERITA is to reduce self-injury through learning and using other ways to regulate emotions. ERITA includes both an adolescent treatment and a separate parent course. The adolescent treatment includes skills training in emotional awareness, impulse control, emotional acceptance, emotional willingness, emotional modulation effectiveness and flexibility, validation, and valued direction. The parent course includes skills training in emotional awareness, validation, self-validation, and behavioral activation. The adolescent treatment is 11 modules, and the parent course is six. The modules include text, videos, and audio resources. The family and therapist decide on how to combine sessions with digital material based on preferences and needs.
BEHAVIORALTreatment as Usual (TAU)
Treatment as usual (TAU) will constitute treatment for NSSI according to local clinical guidelines.
OTHERConcomitant care
Participants are free to receive concomitant care (counselling or medication) in addition to self-injury treatment according to their needs during the trial.
Sponsors
Karolinska Institutet
Region Stockholm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 12-17 years old * At least one NSSI episode in the past three months * A parent willing to engage in the parent program * Global functioning corresponding to a rating ≤50 of the Children's Global Assessment Scale (CGAS)
Exclusion criteria
* Immediate suicide risk * Social problems needing immediate intervention (e.g., violence within the family) * Other psychiatric disorder or symptoms requiring immediate treatment (e.g., severe anorexia nervosa, acute psychosis, severe substance abuse) * Ongoing dialectical behavior therapy for adolescents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of participation in data collection | One-month post-treatment | Proportion of adolescents completing the primary clinical outcome, Deliberate Self-harm Inventory - Youth version, either through interview or self-report questionnaire at one-month post-treatment. |
| Treatment completion | Post-treatment (week 20) | Proportion of adolescents completing ≥ six ERITA modules. Only in the experimental condition. Clinician-rated |
| Therapist time | Post-treatment (week 20) | Therapists will report time for having sessions with adolescents and/or parents or giving feedback on the digital platform. Only in the experimental condition. |
| Credibility/Expectancy Questionnaire (CEQ) | Week 2 (after first week in treatment) | CEQ measures treatment credibility and expectancy. Scale points range from 0-9, and 0-100%, where higher scores indicate greater credibility and expectancy. Self-rated by adolescents. Only in the experimental condition. |
| Emotion regulation therapy adherence checklist | Through study completion, an average of 1 year | This checklist measures therapist adherence to emotion regulation therapy. Adapted to be suitable for therapy with adolescents. Only in the experimental condition. |
| Client Satisfaction Questionnarie (CSQ) | Post-treatment (week 20) | The CSQ measures satisfaction with treatment. This scale has 8 items and a summary score ranging from 8 to 32, with higher scores indicating greater treatment satisfaction. Self-reported (adolescents and parents). |
| Adverse events | Post-treatment and through study completion, an average of 1 year | A scale where participants are asked to report, describe, and rate the discomfort/impact of any negative effects or adverse events caused by their participation in the treatment. Participants rate the impact of potential adverse events when it happened and today on a scale from 1 to 4, where a higher score indicates greater impact. Self-reported (adolescents and parents). Adverse events will be recorded by PI throughout the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deliberate Self-harm Inventory - Youth version (DSHI-Y) | One- and three-months post-treatment | The DSHI-Y is a youth-adaptation of the DSHI and measures the six most common NSSI methods. The primary clinical outcome will be the proportion of treatment remission. Remission will be defined as the absence of NSSI in the past month and measured dichotomously (yes/no). The primary data source will be blinded assessor-rated DSHI-Y. If these data are missing, self-reported DSHI-Y will be used. |
| Difficulties in Emotion Regulation Scale - 16 items version (DERS-16) | Baseline, one-, and three-months post-treatment | The DERS-16 measures difficulties in emotion regulation. The total score ranges from 16 to 80, with higher scores indicating greater difficulties. Self-rated (adolescent and parent). |
| Clinical Global Assessment Scale (CGAS) | Baseline, one-, and three-months post-treatment | The CGAS measures global functioning on a single item ranging from 1 to 100, with a higher value indicating better functioning. Clinician-rated. |
| Borderline Symptom List - Behavior Supplement (BSL-Supplement) | Baseline, one-, and three-months post-treatment | The BSL supplement measures the frequency of self-destructive behaviors. We will measure behaviors of self-harm, suicide attempt, binge eating, self-induced vomiting, high-risk activities, getting drunk, substance use, medication misuse, outbreaks of anger/physical attacks and impulsive/shameful sexual encounters, resulting in a total score between 0 to 40 where a higher score indicates greater frequency of self-destructive behaviors. Self-rated (adolescent). |
| Child Health Utility 9D Index (CHU-9D) | Baseline, one-, and three-months post-treatment | The CHU-9D measures health related quality of life. The scale has 9 items with a summary score between 9 and 45, where a higher score indicates greater health-related quality of life. Self-rated (adolescent). |
| Revised Child Anxiety and Depression Scale-Short Version (RCADS-25) | Baseline, one-, and three-months post-treatment | The RCADS-25 measures symptoms of depression and anxiety in children and adolescents. This version has 25 items with a total score between 0 and 75, with higher scores indicating greater levels of symptoms. Self-rated (adolescent). |
| Coping with Children's Negative Emotions Scale - Adolescent version (CCNES-A) | Baseline, one-, and three-months post-treatment | The CCNES-A measures parental coping in response to adolescents' negative emotions. The CCNES-A consists of nine hypothetical scenarios accompanied by six types of responses (i.e., emotion focused, problem-focused, minimization, punitive, expressive encouragement, and distress responses). Separate summary scores are calculated per subscale (type of response) and ranges from 1 to 7, with higher scores indicating greater usage of a certain parental coping style. Self-rated (parent and adolescent). |
| The Work and Social Adjustment Scale -Youth version (WSAS-Y) | Baseline, one-, and three-months post-treatment | The WSAS-Y measures functional impairment in school, everyday life, friends and social life, recreation and hobbies, and family and close relationships.This 5-item scale generates a summary score between 0 and 40, with higher scores indicating greater impairment. Youths rate their own impairment. Self-rated. |
| The Work and Social Adjustment Scale - Parent version (WSAS-P) | Baseline, one-, and three-months post-treatment | The WSAS-P measures functional impairment in school, everyday life, friends and social life, recreation and hobbies, and family and close relationships.This 5-item scale generates a summary score between 0 and 40, with higher scores indicating greater impairment. Parents rate their youth's impairment. Self-rated. |
Countries
Sweden
Contacts
CONTACTSamantha Khoo
CONTACTOlivia Ojala, PhD
PRINCIPAL_INVESTIGATOROlivia Ojala, PhD
Karolinska Institutet
PRINCIPAL_INVESTIGATORJohan Bjureberg, PhD
Karolinska Institutet
Outcome results
None listed