The overall purpose of the study is to implement and evaluate IERITA (Internet-delivered Emotion Regulation Individual Therapy for Adolescents) within child and adolescent mental health services for adolescents engaging in nonsuicidal self-injury (NSSI) and optimize treatment outcomes for those adolescents at risk of non-remission (continued NSSI).
Nonsuicidal self-injury (NSSI) is a growing and urgent global health crisis among youth. It is associated with substantial individual and societal costs, including increased risk of suicide attempts. Scalable and evidence-based treatments are needed but lacking. Digital interventions can be one promising solution. A recent study shows that a novel brief digital treatment, IERITA, can be efficacious compared to treatment as usual only. However, not all respond sufficiently to standardized treatment, such as IERITA, and continued NSSI entails risks and suffering. In this randomized controlled trial, participants will be randomly allocated (1:1) to standard IERITA or adaptable IERITA. All participants will first receive standard IERITA for four weeks. In treatment week four, or earlier if the adolescent is at risk of discontinuation, classification of non-remission/remission will be conducted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA (e.g., personalized dose and delivery of treatment) for the remaining weeks (until week 12) while all other participants will continue with standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment, and in public registers up to ten years post-treatment. The primary endpoint is one-month post-treatment. The primary aim is to evaluate efficacy of an adaptable treatment strategy for adolescents at risk of non-remission. Secondary aims include implementation, cost-effectiveness, moderators and predictors, distal effects, algorithm performance, and psychometrical evaluations. The specific objectives are: PRIMARY AIM 1. Determine the efficacy of adaptable IERITA compared to standard IERITA for adolescents at risk of non-remission at one-month post-treatment (primary endpoint) and to assess the durability of effects at three-month follow-up SECONDARY AIMS 2. Determine the cost-effectiveness of adaptable IERITA compared to a standard IERITA. 3. Explore the implementation (reach, satisfaction, adherence, level and type of resources, utility) of IERITA in child and adolescent mental health services care. 4. Investigate predictors and moderators of treatment outcome. 5. Evaluate distal outcomes and long-term effects of adaptable IERITA compared to a standard IERITA. 6. Explore the experience of being an IERITA therapist. 7. Evaluate the performance of the algorithm predicting treatment non-remission. 8. Evaluate the psychometric properties of the Deliberate Self-harm Inventory - Youth version (DSHI-Y). 9. Evaluate the agreement between self- and assessor-rated NSSI. Statistical plan is found at: https://osf.io/6h7fe/overview This project is sponsored by the Swedish Research Council (number 2024-03122), Fonden för Psykisk Hälsa, Stiftelsen Söderströmska Königska (number SLS-1031985), and Thuring Foundation (2025-186).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
341
IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support. In the adapted IERITA intervention, the therapists develop an individual case conceptualization that forms the basis for a brief interview with the adolescent after the classification phase (from randomization to treatment week four), during which potential obstacles and necessary adaptations are explored. Adaption can entail scheduled or regular chats or videoconferences, selecting specific material to focus on, and involving additional support persons. The adapted IERITA intervention is offered after the classification phase until treatment week 12.
IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support.
Participants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial.
Karolinska Institutet
Stockholm, Sweden
RECRUITINGDeliberate Self-harm Inventory - Youth version (DSHI-Y)
The DSHI-Y measures the frequency of the most common NSSI behaviors. The primary outcome will be the proportion of treatment remission. Remission will be defined as the absence of self-injury the past 30 days. The primary outcome measure will be the clinician-rated DSHI-Y. In cases where clinician ratings are unavailable, the self-rated DSHI-Y will be used.
Time frame: One-, three- and twelve-months post-treatment
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
The DSHI-Y measures the frequency of the most common NSSI behaviors. Change in NSSI frequency from baseline to respective follow-up will be a secondary outcome. The primary outcome measure will be the clinician-rated DSHI-Y. In cases where clinician ratings are unavailable, the self-rated DSHI-Y will be used.
Time frame: Baseline, one-, three- and twelve-months post-treatment
Children's Global Assessment Scale (CGAS)
The CGAS measures global functioning on a single item ranging from 1 to 100, with a higher value indicating better functioning. Clinician-rated.
Time frame: Baseline, one-, three- and twelve-months post-treatment
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
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).
Time frame: Baseline, one-, three- and twelve-months post-treatment
Child Health Utility 9D (CHU-9D)
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).
Time frame: Baseline, one-, three- and twelve-months post-treatment
Borderline symtom checklist supplement (BSL)
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).
Time frame: Baseline, one-, three- and twelve-months post-treatment
The Revised Child Anxiety and Depression Scale-Short Version (RCADS-25)
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).
Time frame: Baseline, one-, three- and twelve-months post-treatment
The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)
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).
Time frame: Baseline, one-, three- and twelve-months post-treatment
Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)
The TIC-P measures healthcare and societal resource use, including for example items on healthcare resource use, medications, school absenteeism, and parental productivity loss. Self-rated (parent).
Time frame: Baseline, one-, three- and twelve-months post-treatment
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