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Nonsuicidal Self-InjuryNCT06817278

Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services: Pilot Study

A study testing Adaptable IERITA, Standard IERITA and Treatment as usual in people with Nonsuicidal Self-Injury and Self-Harm, run by Karolinska Institutet at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 to optimize treatment outcomes for those adolescents at risk… Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Nonsuicidal Self-Injury, Self-Harm
What is being tested?
Adaptable IERITA, Standard IERITA and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSweden
Study dates
15 Jan 2025to Dec 2036
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 13-17 years old
  • At least one self-injury episode in the past three months
  • A parent willing to engage in the parent program

Who cannot join

  • Immediate suicide risk
  • Global functioning corresponding to a rating ≤40 of the Children's Global Assessment Scale (CGAS)
  • Social problems needing immediate intervention (e.g., violence within the family)
  • Ongoing dialectical behavior therapy for adolescents

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Karolinska Institutet

    Stockholm, 113 64

Other trials in Sweden

About this study

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 to optimize treatment outcomes for those adolescents at risk of insufficient effects. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.

Read the detailed description

Self-injury without the intention to die 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 self-injury entails risks and suffering.

In this randomized controlled pilot 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, non-remission will be predicted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA for the remaining eight weeks while all other participants will continue standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment. The primary endpoint is one-month post-treatment.

The main objective is to investigate the project's feasibility and test key components. The specific objectives are:

  1. Examine the feasibility of the project (treatment satisfaction and adherence, degree of participation in data collection, and level of resources).
  2. Explore the utility of adapted IERITA compared to standard IERITA for adolescents at risk of non-remission.
  3. Evaluate the performance of the algorithm predicting treatment non-remission.

This project is sponsored by the Swedish Research Council for Health, Working life, and Welfare (number 2024-01916)

Being tested
Adaptable IERITA, Standard IERITA, Treatment as usual
Keywords
Nonsuicidal self-injury, Internet-delivered treatment, Self-harm, Adolescence
Medical subject headings
Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adaptable IERITABehavioural

    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. The adapted IERITA intervention is tailored to the participant and can thus entail different adaptions for different participants. Adaptions can entail changes in therapist contact, what material to focus on, and how to work with the treatment. The adapted IERITA intervention is offered between week four and 12.

  • Standard IERITABehavioural

    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 usualOther

    Participants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial.

Study groups in NCT06817278
Study groupRoleWhat they receive
Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usualExperimentalParticipants 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. 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.
Receives: Behavioral: Adaptable IERITA; Other: Treatment as usual
Standard Internet-delivered emotion regulation individual therapy adjunctive to treatment as usualActive comparatorParticipants 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.
Receives: Behavioral: Standard IERITA; Other: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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. Clinician-rated.

    Measured: One-, three- and twelve-months post-treatment

  2. 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.

    Measured: Treatment week 3 and post-treatment (week 12)

  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).

    Measured: Treatment week 3

  4. 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).

    Measured: Post-treatment (week 12)

  5. Therapist time

    Clinicians report time spent on treatment.

    Measured: Post-treatment (week 12)

  6. Number of completed sessions and modules

    Clinicians report number of completed sessions and modules for adolescents and parents.

    Measured: Post-treatment (week 12)

  7. 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).

    Measured: Post-treatment (week 12)

  8. Degree of partcipation in data collection

    The 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

    Measured: One-month post-treatment

  9. 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.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (9)
  1. 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. Clinician-rated.

    Measured: Baseline, one-, three- and twelve-months post-treatment

  2. 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.

    Measured: Baseline, one-, three- and twelve-months post-treatment

  3. 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).

    Measured: Baseline, one-, three- and twelve-months post-treatment

  4. 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).

    Measured: Baseline, one-, three- and twelve-months post-treatment

  5. Borderline symtom checklist supplement (BSL)

    The BSL supplement measures the frequency of eleven self-destructive behaviors. The total score ranges from 0 to 44 where a higher score indicates greater frequency of self-destructive behaviors. Self-rated (adolescent).

    Measured: Baseline, one-, three- and twelve-months post-treatment

  6. 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).

    Measured: Baseline, one-, three- and twelve-months post-treatment

  7. 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).

    Measured: Baseline, one-, three- and twelve-months post-treatment

  8. The Work and Social Adjustment Scale -Youth version (WSAS-Y)

    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.

    Measured: Baseline, one-, three- and twelve-months post-treatment

  9. The Work and Social Adjustment Scale - Parent version (WSAS-P)

    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.

    Measured: Baseline, one-, three- and twelve-months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start15 Jan 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06817278
Sponsor's protocol ID
2024-01916
Status last verified
May 2026
First submitted
16 Jan 2025
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Questions about this trial

What is this clinical trial studying?

A study testing Adaptable IERITA, Standard IERITA and Treatment as usual in people with Nonsuicidal Self-Injury and Self-Harm, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Deliberate Self-harm Inventory - Youth version (DSHI-Y) (time frame: One-, three- and twelve-months post-treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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