Nonsuicidal Self-injuryERITANCT03353961
Internet Delivered ERITA for Nonsuicidal Self-Injury
A study testing Emotion regulation individual therapy and Treatment as usual in people with Nonsuicidal Self-injury, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Nonsuicidal Self-injury
- What is being tested?
- Emotion regulation individual therapy 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
- 166 participants
- Where
- 2 sitesSweden
- Study dates
- 20 Nov 2017to 17 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 nonsuicidal self-injury episodes past year
- ≥ 1 nonsuicidal self-injury episodes past month
- having at least one parent who committed to participate in the parent program
Who cannot join
- Severe suicidal ideation
- a diagnosis of psychotic or bipolar I disorder or ongoing (past month) substance dependence
- the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)
- insufficient understanding of the Swedish language
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council
Stockholm, 113 64
Karolinska Institutet
Stockholm, 113 64
About this study
Official title: Internet Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury: A Randomized Controlled Study
To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.
Read the detailed description
Statistical Analyses
Treatment effects will be evaluated according to the intention-to-treat principle. Primary end-point for all outcomes is post-treatment. Secondary end-point include a controlled 3 month follow-up.
Primary Analysis
The primary outcome analysis will include treatment group (ERITA , TAU) and weekly reports of NSSI frequency measured once every week 4 weeks prior to treatment start, once every week during treatment, and once every week four weeks after treatment termination. Regression analysis modelled for count data will be used to estimate trend over time. Four weeks after treatment termination will be considered primary endpoint. Pairwise contrasts (group x time interaction) from the regression model will be used to evaluate between-group differences at primary endpoint (4 weeks after treatment termination).
Secondary Analyses
Secondary outcomes measured once before, during, and after treatment will be analyzed in a similar fashion as for the primary outcome, modelled after data's distribution (count or continuous). Measures collected only once at baseline and post-treatment will be analyzed with regression analyses including treatment group (online ERITA , TAU) as the between-subjects factor, time (baseline to post) as the within-subjects factor, and group × time interactions, modelled after data's distribution (count or continuous).
Parallel process latent growth curve modeling will be used to determine whether change in week-to-week emotion dysregulation (DERS-16) during treatment mediate the overall effect of ERITA+ETAU on week-to-week change in the primary outcome self-rated NSSI frequency (DSHI-Y).
3 Month Follow-Up
Data collected at 3-month follow-up will be used to determine the extent to which potential treatment gains were maintained both within and between treatment conditions
Update 28 April 2022: As a secondary analyses, we also aim to investigate the effect of treatment moderators (primary aim) and predictors (secondary aim) on NSSI frequency one month after treatment termination. This update was submitted prior to conducting the analyses.
The selection of potential moderators was theoretically and empirically motivated. We will investigate the following variables (measured at baseline):
Age Difficulties in emotion regulation As measured with the Difficulties in Emotion Regulation Scale - 36 item version (DERS) Past month NSSI frequency As measured with the Deliberate Self-Harm Inventory Youth version (DSHI-Y) Global functioning As measured with the Childrens Global Assessment Scale Depressive symptoms As measured with the 21-item Depression Anxiety Stress Scales (DASS-21) Sleep difficulties As measured with the Insomnia Severity Index (ISI) Parental Minimization - discounting or devaluing the child's negative emotions/problems As measured with The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A), subscale minimazation Level of suicidality As measured with the MINI-KID International Neuropsychiatric Interview, version 6
- Conditions
- Nonsuicidal Self-injury
- Being tested
- Emotion regulation individual therapy, Treatment as usual
- Keywords
- NSSI
- 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.
Emotion regulation individual therapyBehavioural
The emotion regulation individual therapy is delivered via an internet platform and includes therapist contact several times per week via the platform.
Treatment as usualBehavioural
Treatment as usual as provided in the community.
| Study group | Role | What they receive |
|---|---|---|
| Adjunctive Internet-delivered ERITA | Experimental | Participants will receive 11 weeks of internet-delivered emotion regulation individual therapy with therapist support adjunctive to treatment as usual as provided in the community. The caregiver(s) will receive 6 modules of internet-delivered parent program with therapist support. Receives: Behavioral: Emotion regulation individual therapy |
| Treatment as usual | Active comparator | Participants will receive treatment as usual for 11 weeks of treatment as usual as provided in the community. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deliberate Self-Harm Inventory Youth version (DSHI-Y)
Frequency of nonsuicidal self-injury
Measured: Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended
Secondary outcomes (7)
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
Difficulties in emotion regulation as primary potential mechanism of change. Ranges from 16-80, with higher scores indicating more difficulties.
Measured: Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended
Difficulties in Emotion Regulation Scale - 36 item version (DERS)
Difficulties in emotion regulation. Ranges from 36-180, with higher scores indicating more difficulties.
Measured: Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
the 21-item Depression Anxiety Stress Scales (DASS-21)
Symptoms of depression, anxiety and stress. Each subscale (depression, anxiety and stress) ranges from 0-21, with higher scores indicating more symptoms.
Measured: Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Borderline Symptom List Supplement
Impulsive self-destructive behaviors
Measured: Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended
Acceptance and Action Questionnaire
Acceptance and valued actions. Ranges from 7-49, with higher scores indicating less acceptance and valued actions.
Measured: Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Childrens Global Assessment Scale
Global functioning. Ranges from 1-100, with higher scores indicating better functioning.
Measured: Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended
The Clinical Global Impressions -Severity and Improvement scales
Global symptom severity and improvement. Severity of illness scale ranges from 1-7, with higher scores indicating higher severity of illness. Global improvement scale ranges from 1-7 with lower scores indicating more improvement.
Measured: Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start20 Nov 2017
- Primary completion7 Jan 2021
- Study completion17 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nonsuicidal Self-injuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Hellner Gumpert, Karolinska Institutet
- Investigators
- Clara Hellner, PhD, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353961
- Sponsor's protocol ID
- 2017/10 BIP ERITA
- Acronym
- ERITA
- Status last verified
- Apr 2022
- First submitted
- 2 Nov 2017
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ojala O, Sjoblom K, Hesser H, Hedman-Lagerlof E, Hellner C, Bjureberg J. Parents' coping with their adolescent's negative emotions following internet-delivered emotion regulation therapy for adolescents with non-suicidal self-injury disorder: a secondary analysis of a randomised clinical trial. BMJ Ment Health. 2026 Jan 29;29(1):e302039. doi: 10.1136/bmjment-2025-302039.
PubMed 41611448Ponten M, Flygare O, Bellander M, Karemyr M, Nilbrink J, Hellner C, Ojala O, Bjureberg J. Comparison between clinician and machine learning prediction in a randomized controlled trial for nonsuicidal self-injury. BMC Psychiatry. 2024 Dec 18;24(1):904. doi: 10.1186/s12888-024-06391-x.
PubMed 39695442Bjureberg J, Ojala O, Hesser H, Habel H, Sahlin H, Gratz KL, Tull MT, Claesdotter Knutsson E, Hedman-Lagerlof E, Ljotsson B, Hellner C. Effect of Internet-Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2322069. doi: 10.1001/jamanetworkopen.2023.22069.
PubMed 37440232Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
PubMed 33677832
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03353961
- Acronym / sponsor ID
- ERITA / 2017/10 BIP ERITA
- Conditions
- Nonsuicidal Self-injury
- Keywords
- NSSI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 17 Oct 2021 (actual)
- First posted
- 27 Nov 2017 (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.
To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.
Detailed description
Statistical Analyses
Treatment effects will be evaluated according to the intention-to-treat principle. Primary end-point for all outcomes is post-treatment. Secondary end-point include a controlled 3 month follow-up.
Primary Analysis
The primary outcome analysis will include treatment group (ERITA , TAU) and weekly reports of NSSI frequency measured once every week 4 weeks prior to treatment start, once every week during treatment, and once every week four weeks after treatment termination. Regression analysis modelled for count data will be used to estimate trend over time. Four weeks after treatment termination will be considered primary endpoint. Pairwise contrasts (group x time interaction) from the regression model will be used to evaluate between-group differences at primary endpoint (4 weeks after treatment termination).
Secondary Analyses
Secondary outcomes measured once before, during, and after treatment will be analyzed in a similar fashion as for the primary outcome, modelled after data's distribution (count or continuous). Measures collected only once at baseline and post-treatment will be analyzed with regression analyses including treatment group (online ERITA , TAU) as the between-subjects factor, time (baseline to post) as the within-subjects factor, and group × time interactions, modelled after data's distribution (count or continuous).
Parallel process latent growth curve modeling will be used to determine whether change in week-to-week emotion dysregulation (DERS-16) during treatment mediate the overall effect of ERITA+ETAU on week-to-week change in the primary outcome self-rated NSSI frequency (DSHI-Y).
3 Month Follow-Up
Data collected at 3-month follow-up will be used to determine the extent to which potential treatment gains were maintained both within and between treatment conditions
Update 28 April 2022: As a secondary analyses, we also aim to investigate the effect of treatment moderators (primary aim) and predictors (secondary aim) on NSSI frequency one month after treatment termination. This update was submitted prior to conducting the analyses.
The selection of potential moderators was theoretically and empirically motivated. We will investigate the following variables (measured at baseline):
Age Difficulties in emotion regulation As measured with the Difficulties in Emotion Regulation Scale - 36 item version (DERS) Past month NSSI frequency As measured with the Deliberate Self-Harm Inventory Youth version (DSHI-Y) Global functioning As measured with the Childrens Global Assessment Scale Depressive symptoms As measured with the 21-item Depression Anxiety Stress Scales (DASS-21) Sleep difficulties As measured with the Insomnia Severity Index (ISI) Parental Minimization - discounting or devaluing the child's negative emotions/problems As measured with The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A), subscale minimazation Level of suicidality As measured with the MINI-KID International Neuropsychiatric Interview, version 6
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjunctive Internet-delivered ERITA | Experimental | Behavioral: Emotion regulation individual therapyParticipants will receive 11 weeks of internet-delivered emotion regulation individual therapy with therapist support adjunctive to treatment as usual as provided in the community. The caregiver(s) will receive 6 modules of internet-delivered parent program with therapist support. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualParticipants will receive treatment as usual for 11 weeks of treatment as usual as provided in the community. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ≥ 5 nonsuicidal self-injury episodes past year
- ≥ 1 nonsuicidal self-injury episodes past month
- having at least one parent who committed to participate in the parent program
Key exclusion criteria (4 listed)
- Severe suicidal ideation
- a diagnosis of psychotic or bipolar I disorder or ongoing (past month) substance dependence
- the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)
- insufficient understanding of the Swedish language
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 therapyThe emotion regulation individual therapy is delivered via an internet platform and includes therapist contact several times per week via the platform. | Behavioural | Adjunctive Internet-delivered ERITA |
| Treatment as usualTreatment as usual as provided in the community. | Behavioural | Treatment as usual |
Primary outcome
Deliberate Self-Harm Inventory Youth version (DSHI-Y)
Time frame: Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended
Frequency of nonsuicidal self-injury
7 secondary outcomes
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
Time frame: Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended
Difficulties in Emotion Regulation Scale - 36 item version (DERS)
Time frame: Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
the 21-item Depression Anxiety Stress Scales (DASS-21)
Time frame: Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Borderline Symptom List Supplement
Time frame: Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended
Acceptance and Action Questionnaire
Time frame: Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Childrens Global Assessment Scale
Time frame: Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended
The Clinical Global Impressions -Severity and Improvement scales
Time frame: Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 41611448Ojala O, Sjoblom K, Hesser H, Hedman-Lagerlof E, Hellner C, Bjureberg J. Parents' coping with their adolescent's negative emotions following internet-delivered emotion regulation therapy for adolescents with non-suicidal self-injury disorder: a secondary analysis of a randomised clinical trial. BMJ Ment Health. 2026 Jan 29;29(1):e302039. doi: 10.1136/bmjment-2025-302039.
- Derived from this study: PubMed 39695442Ponten M, Flygare O, Bellander M, Karemyr M, Nilbrink J, Hellner C, Ojala O, Bjureberg J. Comparison between clinician and machine learning prediction in a randomized controlled trial for nonsuicidal self-injury. BMC Psychiatry. 2024 Dec 18;24(1):904. doi: 10.1186/s12888-024-06391-x.
- Derived from this study: PubMed 37440232Bjureberg J, Ojala O, Hesser H, Habel H, Sahlin H, Gratz KL, Tull MT, Claesdotter Knutsson E, Hedman-Lagerlof E, Ljotsson B, Hellner C. Effect of Internet-Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2322069. doi: 10.1001/jamanetworkopen.2023.22069.
- Derived from this study: PubMed 33677832Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
- Individual participant dataSharing planned: No
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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.
Clara Hellner, PhD, MD principal investigator
Karolinska Institutet
2 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 and Treatment as usual in people with Nonsuicidal Self-injury, run by Karolinska Institutet at 2 sites 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: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353961, which also lists 4 linked publications.
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 5 May 2022.