Self-Injurious BehaviorNCT05179655
TEENS Multi-site Trial
A study testing Emotion Regulation Individual Therapy for Adolescents (ERITA) and Treatment as usual in people with Self-Injurious Behavior, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 4 sites in Denmark.
Trial summary
Emotion Regulation Individual Therapy for Adolescents, also called ERITA, is a youth friendly online therapy aiming to provide skills and train emotion regulation. The aim of the TEENS Multi-site Trial is to investigate the effect of ERITA, including an app, as add-on to treatment as usual in young patients referred… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Self-Injurious Behavior
- What is being tested?
- Emotion Regulation Individual Therapy for Adolescents (ERITA) and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Feb 2022to 31 Dec 2027
- 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
- ≥ 5 non-suicidal self-injury episodes in the past year and ≥ 1 non-suicidal self-injury episodes in the past month assessed by the Deliberate Self-Harm Inventory, Youth version (DSHI-Y).
- Age-appropriate literacy assessed by referring clinicians and the self-injury team, i.e. age between 13 and 17.
- Having at least one parent committing to participate in the parent program.
- Informed consent from parents/legal caretakers and assent from participants above 15 years of age.
Who cannot join
- Imminent suicidal risk assessed by clinicians during routine screening procedure (that can be rated as no risk, elevated risk, or imminent risk) in need of admission or other life saving strategies.
- Lack of informed consent from parents/legal caretakers.
- Lack of informed assent from the participant above 15 years of age.
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Child and Adolescent Mental Health Services
Aalborg, 9000
Team for Self-injury, Child and Adolescent Mental Health Services, B195
Copenhagen, Ø, 2100
Child and Adolescent Mental Health Services Southern Region Denmark
Odense, 5000
Child and Adolescent Mental Health Services in Region Zealand
Roskilde, 4000
About this study
Emotion Regulation Individual Therapy for Adolescents, also called ERITA, is a youth friendly online therapy aiming to provide skills and train emotion regulation.
The aim of the TEENS Multi-site Trial is to investigate the effect of ERITA, including an app, as add-on to treatment as usual in young patients referred to Mental Health Services. We expect 356 families to participate from three designated Regions in Denmark.
Read the detailed description
Background: A prevalence of non-suicidal self-injury is not easily assessed; however, meta-analyses found a lifetime prevalence of 17% in non-clinical student samples. This estimate increases to 50-74% in psychiatric populations. Non-suicidal self-injury is an important predictor for later suicidal behavior and death by suicide. Although non-suicidal self-injury is highly prevalent, there is no evidence for specific treatment for non-suicidal self-injury in adolescents. Reviews find that internet-based interventions guided by a therapist are effective for several psychiatric disorders such as anxiety and depression in adult population. Patients with stigmatizing illnesses such as non-suicidal self-injury may be reluctant to seek help and adhere with treatment while internet-based interventions are more appealing. There is a need for trials investigating the effect of specialized interventions for non-suicidal self-injury in youth, including digital interventions.
Objective: To investigate the effect of an internet-based intervention, Emotion Regulation Individual Therapy for Adolescents (ERITA), as add-on to treatment as usual in 13-17-year-old patients with non-suicidal self-injury referred to Child- and Adolescent Mental Health Services with subsequent non-suicidal self-injury as primary outcome assessed by Deliberate Self-Harm Inventory - Youth. Further clinical outcomes such as quality of life, depression, anxiety and stress, as well as emotion regulation difficulties will be assessed as secondary outcomes.
Method and materials: This is a randomized, clinical, superiority, multicenter trial in a parallel group design. Patients will be recruited from Child- and Adolescent Mental Health Services in three of the Danish Regions: The trial inclusion period will be from primo 2022 to ultimo 2023. The experimental intervention is therapist guided internet-based ERITA provided exclusively online as add-on to treatment as usual in the experimental group. Treatment as usual is provided by multidisciplinary teams in outpatient clinics in all participating regions. We expect to include 356 participants and one of their parents.
- Conditions
- Self-Injurious Behavior
- Being tested
- Emotion Regulation Individual Therapy for Adolescents (ERITA), Treatment as usual
- Keywords
- Internet-based intervention, Online therapy, Emotion regulation, ERITA
- Medical subject headings
- Self-Injurious Behavior, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation Individual Therapy for Adolescents (ERITA)Behavioural
Also called ERITA
The ERITA intervention as add-on to TAU consists of 11 weeks, manualized online therapy based on the methods of Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), and Acceptance and Commitment Therapy (ACT) adapted for youth. The ERITA content consists of psychoeducation, emotion recognition, awareness training and theory of emotion regulation, including acceptance and validation skills.
Treatment as usualOther
Within Mental Health Services in Denmark child and adolescent psychiatrists provide specialized treatment for young psychiatric patients as outpatient services. In this trial the control intervention is treatment as usual (TAU) and consists of clinical assessment and treatment for patient's current primary psychiatric condition. TAU encounters a variety of clinical treatment and assessment offers, however, all within the field of expertise in child and adolescent psychiatry; out-patient care may consist of treatment for OCD, eating disorders, psychoses or affective disorders. TAU may consist of pharmacological treatment, Family-Based Treatment (FBT), Cognitive Behavioral Therapy (CBT), supportive counselling and/or psychoeducation.
| Study group | Role | What they receive |
|---|---|---|
| ERITA + TAU (Treatment as usual) | Experimental | The Emotion Regulation Individual Therapy for Adolescents (ERITA) intervention as add-on to TAU consists of 11 weeks, manualized online therapy based on the methods of Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), and Acceptance and Commitment Therapy (ACT) adapted for youth Receives: Behavioral: Emotion Regulation Individual Therapy for Adolescents (ERITA); Other: Treatment as usual |
| TAU (Treatment as usual) | Other | Within mental health services in Denmark child and adolescent psychiatrists provide specialized treatment for young psychiatric patients as outpatient services. In this study the control intervention (TAU) consists of clinical assessment and treatment for patient's current primary psychiatric condition (referral condition and A-diagnosis). Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-suicidal self-injury episodes
Non-suicidal self-injury within the last four weeks, at end of intervention (12 weeks) by blinded outcome assessment by phone or video conference measured by Deliberate Self-Harm Inventory
Measured: End of treatment after 12 weeks and 6 months follow-up
Secondary outcomes (3)
Kidscreen-10; Quality of life
Quality of life at 12 weeks, assessed with Kidscreen-10, a five point likert scale, range: not at all, a little, moderate, much, very much.
Measured: End of treatment after 12 weeks and 6 months follow-up
Symptoms of depression, anxiety and stress
Symptoms of depression, anxiety and stress at 12 weeks, assessed with Depression Anxiety Stress Scale (DASS-21) presented as analyses for each subgroup item. Four point likert scale, range: did not apply to me, applied to me to some degree, applied to me to a considerable degree, applied to me much/most of the time. Total rage for subscores: 0-42. Higher scores reflect worse outcome.
Measured: End of treatment after 12 weeks and 6 months follow-up
Non-suicidal self-injury as dichotomous (any/none)
The proportion of participants with any NSSI during the past four weeks.
Measured: End of treatment after 12 weeks and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Feb 2022
- Primary completion15 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-Injurious BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- An investigator-initiated, multi-site randomised, parallel group, clinical superiority trial with blinded outcome assessment investigating the internet-based intervention ERITA as add-on to TAU compared to TAU alone in NSSI engaging psychiatric, outpatient youth. Participants will be randomised at the allocation ratio 1:1. Randomisation will be handled centrally at the Copenhagen Trial Unit (CTU) using a computer-generated allocation sequence with a varying block size concealed from the investigators. The allocation sequence will be stratified NSSI at baseline 1-10 versus 11≤ episodes in the past month, and trial site. CTU will generate the allocation sequence and investigators at the clinical trial sites will assign participants to the intervention groups using an OpenClinica web-based system developed by the CTU
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, Region of Southern Denmark, Region Zealand, North Denmark Region
- Responsible party
- Principal investigator, Britt Reuter Morthorst, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Anne K Pagsberg, Professor, Study chair, Mental Health Services Capital Region Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179655
- Sponsor's protocol ID
- H-21035306
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEENS Multi-site Trial
- ClinicalTrials.gov ID
- NCT05179655
- Acronym / sponsor ID
- H-21035306
- Conditions
- Self-Injurious Behavior
- Keywords
- Internet-based intervention, Online therapy, Emotion regulation, ERITA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, Region of Southern Denmark, Region Zealand, North Denmark Region
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emotion Regulation Individual Therapy for Adolescents, also called ERITA, is a youth friendly online therapy aiming to provide skills and train emotion regulation.
The aim of the TEENS Multi-site Trial is to investigate the effect of ERITA, including an app, as add-on to treatment as usual in young patients referred to Mental Health Services. We expect 356 families to participate from three designated Regions in Denmark.
Detailed description
Background: A prevalence of non-suicidal self-injury is not easily assessed; however, meta-analyses found a lifetime prevalence of 17% in non-clinical student samples. This estimate increases to 50-74% in psychiatric populations. Non-suicidal self-injury is an important predictor for later suicidal behavior and death by suicide. Although non-suicidal self-injury is highly prevalent, there is no evidence for specific treatment for non-suicidal self-injury in adolescents. Reviews find that internet-based interventions guided by a therapist are effective for several psychiatric disorders such as anxiety and depression in adult population. Patients with stigmatizing illnesses such as non-suicidal self-injury may be reluctant to seek help and adhere with treatment while internet-based interventions are more appealing. There is a need for trials investigating the effect of specialized interventions for non-suicidal self-injury in youth, including digital interventions.
Objective: To investigate the effect of an internet-based intervention, Emotion Regulation Individual Therapy for Adolescents (ERITA), as add-on to treatment as usual in 13-17-year-old patients with non-suicidal self-injury referred to Child- and Adolescent Mental Health Services with subsequent non-suicidal self-injury as primary outcome assessed by Deliberate Self-Harm Inventory - Youth. Further clinical outcomes such as quality of life, depression, anxiety and stress, as well as emotion regulation difficulties will be assessed as secondary outcomes.
Method and materials: This is a randomized, clinical, superiority, multicenter trial in a parallel group design. Patients will be recruited from Child- and Adolescent Mental Health Services in three of the Danish Regions: The trial inclusion period will be from primo 2022 to ultimo 2023. The experimental intervention is therapist guided internet-based ERITA provided exclusively online as add-on to treatment as usual in the experimental group. Treatment as usual is provided by multidisciplinary teams in outpatient clinics in all participating regions. We expect to include 356 participants and one of their parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- An investigator-initiated, multi-site randomised, parallel group, clinical superiority trial with blinded outcome assessment investigating the internet-based intervention ERITA as add-on to TAU compared to TAU alone in NSSI engaging psychiatric, outpatient youth. Participants will be randomised at the allocation ratio 1:1. Randomisation will be handled centrally at the Copenhagen Trial Unit (CTU) using a computer-generated allocation sequence with a varying block size concealed from the investigators. The allocation sequence will be stratified NSSI at baseline 1-10 versus 11≤ episodes in the past month, and trial site. CTU will generate the allocation sequence and investigators at the clinical trial sites will assign participants to the intervention groups using an OpenClinica web-based system developed by the CTU
| Arm | Type | Receives |
|---|---|---|
| ERITA + TAU (Treatment as usual) | Experimental | Behavioral: Emotion Regulation Individual Therapy for Adolescents (ERITA), Other: Treatment as usualThe Emotion Regulation Individual Therapy for Adolescents (ERITA) intervention as add-on to TAU consists of 11 weeks, manualized online therapy based on the methods of Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), and Acceptance and Commitment Therapy (ACT) adapted for youth |
| TAU (Treatment as usual) | Other | Other: Treatment as usualWithin mental health services in Denmark child and adolescent psychiatrists provide specialized treatment for young psychiatric patients as outpatient services. In this study the control intervention (TAU) consists of clinical assessment and treatment for patient's current primary psychiatric condition (referral condition and A-diagnosis). |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ≥ 5 non-suicidal self-injury episodes in the past year and ≥ 1 non-suicidal self-injury episodes in the past month assessed by the Deliberate Self-Harm Inventory, Youth version (DSHI-Y).
- Age-appropriate literacy assessed by referring clinicians and the self-injury team, i.e. age between 13 and 17.
- Having at least one parent committing to participate in the parent program.
- Informed consent from parents/legal caretakers and assent from participants above 15 years of age.
Key exclusion criteria (3 listed)
- Imminent suicidal risk assessed by clinicians during routine screening procedure (that can be rated as no risk, elevated risk, or imminent risk) in need of admission or other life saving strategies.
- Lack of informed consent from parents/legal caretakers.
- Lack of informed assent from the participant above 15 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion Regulation Individual Therapy for Adolescents (ERITA)Also: ERITAThe ERITA intervention as add-on to TAU consists of 11 weeks, manualized online therapy based on the methods of Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), and Acceptance and Commitment Therapy (ACT) adapted for youth. The ERITA content consists of psychoeducation, emotion recognition, awareness training and theory of emotion regulation, including acceptance and validation skills. | Behavioural | ERITA + TAU (Treatment as usual) |
| Treatment as usualWithin Mental Health Services in Denmark child and adolescent psychiatrists provide specialized treatment for young psychiatric patients as outpatient services. In this trial the control intervention is treatment as usual (TAU) and consists of clinical assessment and treatment for patient's current primary psychiatric condition. TAU encounters a variety of clinical treatment and assessment offers, however, all within the field of expertise in child and adolescent psychiatry; out-patient care may consist of treatment for OCD, eating disorders, psychoses or affective disorders. TAU may consist of pharmacological treatment, Family-Based Treatment (FBT), Cognitive Behavioral Therapy (CBT), supportive counselling and/or psychoeducation. | Other | ERITA + TAU (Treatment as usual), TAU (Treatment as usual) |
Primary outcome
Non-suicidal self-injury episodes
Time frame: End of treatment after 12 weeks and 6 months follow-up
Non-suicidal self-injury within the last four weeks, at end of intervention (12 weeks) by blinded outcome assessment by phone or video conference measured by Deliberate Self-Harm Inventory
3 secondary outcomes
Kidscreen-10; Quality of life
Time frame: End of treatment after 12 weeks and 6 months follow-up
Symptoms of depression, anxiety and stress
Time frame: End of treatment after 12 weeks and 6 months follow-up
Non-suicidal self-injury as dichotomous (any/none)
Time frame: End of treatment after 12 weeks and 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne K Pagsberg, Professor study chair
Mental Health Services Capital Region Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Regulation Individual Therapy for Adolescents (ERITA) and Treatment as usual in people with Self-Injurious Behavior, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 4 sites in Denmark.
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 4 inclusion and 3 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
Non-suicidal self-injury episodes (time frame: End of treatment after 12 weeks and 6 months follow-up). 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 9 Oct 2026.