Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
| Region Skane | OTHER |
| Vastra Gotaland Region | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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
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
Determine the cost-effectiveness of adaptable IERITA compared to a standard IERITA.
Explore the implementation (reach, satisfaction, adherence, level and type of resources, utility) of IERITA in child and adolescent mental health services care.
Investigate predictors and moderators of treatment outcome.
Evaluate distal outcomes and long-term effects of adaptable IERITA compared to a standard IERITA.
Explore the experience of being an IERITA therapist.
Evaluate the performance of the algorithm predicting treatment non-remission.
Evaluate the psychometric properties of the Deliberate Self-harm Inventory - Youth version (DSHI-Y).
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual | Experimental | Participants will receive Internet-delivered Emotion Regulation Individual Therapy (IERITA) for 12 weeks. Adolescents allocated to experimental arm and classified as likely non-remission, will change to adapted IERITA in treatment week four (or earlier if the adolescent is at risk of discontinuation). Adolescents allocated to experimental arm and classified as likely remission will continue standard IERITA. In addition to IERITA, participants are free to will receive any type of treatment as usual for 12 weeks as provided in the community. |
|
| Standard Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual | Active Comparator | Participants will receive Internet-delivered Emotion Regulation Individual Therapy (IERITA) for 12 weeks. All participants will continue standard IERITA throughout the treatment period. In addition to IERITA, participants are free to will receive any type of treatment as usual for 12 weeks as provided in the community. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptable IERITA | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Deliberate 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. | One-, three- and twelve-months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, one-, three- and twelve-months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Internet Intervention Patient Adherence Scale (iiPAS) | The IIPAS measures patient adherence to guided internet-delivered behavioral interventions. This scale has 5 items, and a total score ranging from 0 to 20, where 0 indicates no adherence and 20 perfect adherence. Clinician-rated. | Treatment week 3 and post-treatment (week 12) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivia Ojala, PhD | Contact | +46761426565 | olivia.ojala@ki.se | |
| Johan Bjureberg, PhD | Contact | +460852480000 | johan.bjureberg@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Johan Bjureberg, PhD | Karolinska Institutet | Principal Investigator |
| Olivia Ojala, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Recruiting | Stockholm | 113 64 | Sweden |
The data is pseudonymized in accordance with Swedish and European Union laws and cannot be anonymized and published in an open repository. Study participants have consented to sharing their data with international researchers for meta-analyses. Aggregated data can be provided upon reasonable request on a case-by-case basis in compliance with current legislation and ethical permits.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Therapists will be partially blinded. They will be blinded to treatment allocation and participant classification until treatment week 4, or until a participant is classified as a likely non-remission. At treatment week 4, blinding will be broken only for the subset of participants classified as likely non-remission who are allocated to the adaptable IERITA condition. Therapists will remain blinded to allocation and classification for most participants throughout the trial.
|
| Standard IERITA | Behavioral | 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. |
|
| Treatment as usual | Other | Participants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial. |
|
| 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. | 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). | 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). | 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). | 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). | 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). | 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). | Baseline, one-, three- and twelve-months post-treatment |
| Participant-rated adherence |
Two items asking the participant to rate their own adherence the past week. Self-rated (adolescent). |
| Treatment week 3 |
| Credibility | Two items asking the participant to rate change in treatment credibility from the previous treatment week. Self-rated (adolescent). | Treatment week 3 |
| Credibility/Expectancy Questionnaire (CEQ) - 1 item version | CEQ measures treatment credibility and expectancy. This version of the scale has 1 item ranging from 0 to 100, with higher scores indicating greater credibility/expectancy. Self-rated (adolescent). | Treatment week 2 |
| The Client Satisfaction Questionnaire (CSQ) | 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-rated (adolescent and parent). | Post-treatment (week 12) |
| Adverse events | A scale were 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-rated (adolescent and parent). | Post-treatment (week 12) |
| Columbia-Suicide Severity Rating Scale (C-SSRS) - 6 item version | The C-SSRS - 6 item version measures the frequency and severity of suicidal ideation and behaviors. Clinician-rated. | Baseline |
| Concomitant treatment | Participants report presence, type, focus, and change an of any potential other concomitant treatment during the trial. Self-rated (adolescent and parent). | Post-treatment (week 12), one- and three-months post-treatment |
| Therapist time | Clinicians report time spent on treatment. | Post-treatment (week 12) |
| Number of completed sessions and modules | Clinicians report number of completed sessions and modules for adolescents and parents. | Post-treatment (week 12) |
| Deliberate Self-harm Inventory - Youth version (DSHI-Y) | The DSHI-Y measures the frequency of the most common NSSI behaviors. Self-rated (adolescent). | Week 1 to 12, and post-treatment (week 12) |
| 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). | Week 1 to 12 |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Two items about suicidal behavior from the C-SSRS are used to measure suicidality during treatment. The items concern preparatory behavior and suicide attempts the past seven days. Self-rated (adolescent). | Week 1 to 12 |
| Inventory of Statements About Self-injury (ISAS) | ISAS measures frequency, function, age of onset, experience of, and willingness to stop engaging in self-injury. There are 39 items describing common functions of self-injury. Participants are asked to rate if a certain function applies to them, by marking the statement as "Not relevant", "Partly relevant", or "Very relevant". Self-rated (adolescent). | Baseline |
| The Swedish version of the Normalization Process Theory Measure (S-NoMAD) | S-NoMAD measures implementation of interventions from a normalization process theory perspective. The first section in S-NoMAD includes questions about the respondent, the second (2 items) and third (20 items) include questions about the intervention. The items in the second section are answered on a 10-point Likert scale ranging from "Not at all" to "Completely". The items in the third section are answered using a 5-point Likert scale, ranging from "Disagree Strongly" to "Agree Strongly". Participating clinicians answer the S-NoMAD once, after they have treated at least three families with the intervention (i.e., to have some experience of the intervention). | Through study completion for primary outcome measure and endpoint, an average of 3 years |
| Experiences of self- and assessor-rated nonsuicidal self-injury (NSSI) reports | Adolescents will be asked two questions about the format used to report NSSI: (1) "What was your experience of reporting NSSI in the different formats?", and in case where discrepancies occur between the two reporting formars between: (2) "Which frequency rating do you prefer?". Both questions will be administered by an assessor during a single assessment session. | Baseline, one- or three-months post-treatment |
| Adapted ICBT Therapist Rating Scale (ICBT-TRS) | Therapist behaviors are rated separately as 0 (absence of behavior), 1 (inadequate performance), or 2 (competent). Rated by experienced clinical supervisors. | Through study completion, an average of 1 year |
| Rate of treatment adaptions | Clinicians report presence or absence of possible treatment adaptions (e.g., changes in therapist contact or what material to focus on). | Post-treatment (week 12) |
| Treatment benefit | Participants are asked to rate, using a single item, the perceived benefit of the intervention-specifically, how much of the knowledge gained continues to help them today. Self-rated (adolescent and parent). | Twelve-months post-treatment |
| Demographical and clinical background data | Current mental health disorders, age, previous and current treatment. Clinician-rated. Gender and sexual orientation. Self-rated (adolescent). Country of birth, living situation, parental occupation, parental academic degree, and parental history of mental health disorders. Self-report (parent) | Baseline |
| Lifestyle behaviors | Four questions asking participants to rate how frequently they engage in the following activities: eating candy, drinking soda, playing video or computer games, and watching movies. Clinician-rated and self-rated (adolescent) | Baseline |
| Number of healthcare visits | Registry data from the National Patient Register. | 1 to 10 years post-treatment |
| Academic performance | Grades and eligibility in primary school and upper secondary school, and highest education level. Registry data from the Swedish National Agency for Education and the Swedish longitudinal integrated database for health insurance and labour market studies (LISA). | 1 to 10 years post-treatment |
| Mental health disorders | Registered psychiatric disorders. Registry data from the National Patient Register. | 1 to 10 years post-treatment |
| Occupation | Occupation, including unemployment and sick leave. Registry data from the Swedish longitudinal integrated database for health insurance and labour market studies (LISA). | 1 to 10 years post-treatment |
| Reasons for eventual death | Registry data from the National Cause of Death Register. | 1 to 10 years post-treatment |
| Prescription of psychotropics | Registry data from the National Prescribed Drug Register. | 1 to 10 years post-treatment |
| Suicide attempts | Suicide attempts registered by the health care. Registry data from the National Patient Register and Regional Healthcare Registers. | 1 to 10 years post-treatment |
| The Revised Child Anxiety and Depression Scale (RCADS) | The RCADS measures symptoms of depression and anxiety in children and adolescents. RCADS has 47 items with a total score between 0 and 141, with higher scores indicating greater levels of symptoms. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP). | 1 to 10 years post-treatment |
| Kidscreen-10 | The Kidscreen-10 measures quality of life through 10 items. The summary score ranges from 10 to 50 where a higher score indicates greater quality of life. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP). | 1 to 10 years 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. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP). | 1 to 10 years post-treatment |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided