Non Suicidal Self InjuryNCT07337473
Evidence-based Digital CBT for Nonsuicidal Self-Injury
A study testing Evidence-based digital cognitive behaviour therapy and Health Education in people with Non Suicidal Self Injury and Cognitive Behavior Therapy, run by Peking University Sixth Hospital.
Trial summary
To evaluate if evidence-based digital cognitive behaviour therapy for adolescents is an efficacious treatment when delivered as an adjunctive treatment to treatment as usual, compared to a control group consisting of treatment as usual. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Non Suicidal Self Injury, Cognitive Behavior Therapy
- What is being tested?
- Evidence-based digital cognitive behaviour therapy and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to 30 Jan 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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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 program
Who cannot join
- Severe suicidal ideation a diagnosis of psychotic or ongoing (past month) substance dependence the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Evidence-based Digital Cognitive Behavior Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial
To evaluate if evidence-based digital cognitive behaviour therapy for adolescents is an efficacious treatment when delivered as an adjunctive treatment to treatment as usual, compared to a control group consisting of treatment as usual.
- Being tested
- Evidence-based digital cognitive behaviour therapy, Health Education
- 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.
Evidence-based digital cognitive behaviour therapyBehavioural
The Evidence-based digital cognitive behaviour therapy is delivered via an internet platform during the intervention period via the platform.
Health EducationBehavioural
The Health Education therapy is delivered via an internet platform during the intervention period via the platform.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-based digital CBT group | Experimental | Participants will receive 6 weeks of evidence-based digital cognitive behaviour therapy, adjunctive to treatment as usual, as provided in the community or research group. Receives: Behavioral: Evidence-based digital cognitive behaviour therapy |
| Health Education group | Active comparator | Participants will receive health education for 6 weeks, adjunctive to treatment as usual, as provided in the community or research group. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ottawa Self-injury Inventory（OSI）
Assessing the frequency and severity of nonsuicidal self-injury
Measured: From the date of baseline assessment (enrollment) until the date of 12-month follow-up, assessed at baseline, post-treatment (Day 1 of the week following treatment completion), and 1 month, 6 months, and 12 months after post-treatment.
Secondary outcomes (5)
General Anxiety Disorder-7
GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety.
Measured: Change from baseline (Day 1 of study enrollment), assessed every 2 weeks during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.
Patient Health Questionnaire-9
The Patient Health Questionnaire-9 (PHQ-9) is a widely used brief screening tool that can assist both in identifying individuals with major depression disorder, as well as assessing the severity of depressive symptoms.
Measured: Change from baseline (Day 1 of study enrollment), assessed every 2 weeks during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.
Beck's Suicide Intent Scale
The total score of the BSSI ranges from 0 to 37, with higher scores indicating more severe suicidal ideation
Measured: Change from baseline (Day 1 of study enrollment), assessed every week during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.
Self-harm behaviour craving visual analog scale
Assessment of self-harm behaviour craving in NSSI adolescent
Measured: Change from baseline (Day 1 of study enrollment), assessed every week during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.
Difficulties in Emotion Regulation Scale - 16-item version (DERS)
Difficulties in emotion regulation. Higher scores indicate more difficulties.
Measured: Change from baseline (Day 1 of study enrollment), assessed at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
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 Non Suicidal Self InjuryStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Zhong, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337473
- Sponsor's protocol ID
- PekingUSH 20251020
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of the research results, the data will be shared on this website and relevant journal platforms
Publications
Bjureberg 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 37440232Morthorst B, Olsen MH, Jakobsen JC, Lindschou J, Gluud C, Heinrichsen M, Mohl B, Rubaek L, Ojala O, Hellner C, Bjureberg J, Pagsberg AK. Internet based intervention (Emotion Regulation Individual Therapy for Adolescents) as add-on to treatment as usual versus treatment as usual for non-suicidal self-injury in adolescent outpatients: The TEENS randomised feasibility trial. JCPP Adv. 2022 Dec 3;2(4):e12115. doi: 10.1002/jcv2.12115. eCollection 2022 Dec.
PubMed 37431416Kaess M, Edinger A, Fischer-Waldschmidt G, Parzer P, Brunner R, Resch F. Effectiveness of a brief psychotherapeutic intervention compared with treatment as usual for adolescent nonsuicidal self-injury: a single-centre, randomised controlled trial. Eur Child Adolesc Psychiatry. 2020 Jun;29(6):881-891. doi: 10.1007/s00787-019-01399-1. Epub 2019 Sep 11.
PubMed 31512050Franklin JC, Fox KR, Franklin CR, Kleiman EM, Ribeiro JD, Jaroszewski AC, Hooley JM, Nock MK. A brief mobile app reduces nonsuicidal and suicidal self-injury: Evidence from three randomized controlled trials. J Consult Clin Psychol. 2016 Jun;84(6):544-57. doi: 10.1037/ccp0000093. Epub 2016 Mar 28.
PubMed 27018530
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Evidence-based Digital Cognitive Behavior Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07337473
- Acronym / sponsor ID
- PekingUSH 20251020
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 13 Jan 2026 (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 evidence-based digital cognitive behaviour therapy for adolescents is an efficacious treatment when delivered as an adjunctive treatment to treatment as usual, compared to a control group consisting of treatment as usual.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evidence-based digital CBT group | Experimental | Behavioral: Evidence-based digital cognitive behaviour therapyParticipants will receive 6 weeks of evidence-based digital cognitive behaviour therapy, adjunctive to treatment as usual, as provided in the community or research group. |
| Health Education group | Active comparator | Behavioral: Health EducationParticipants will receive health education for 6 weeks, adjunctive to treatment as usual, as provided in the community or research group. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 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 program
Key exclusion criteria (1 listed)
- Severe suicidal ideation a diagnosis of psychotic or ongoing (past month) substance dependence the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)
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 |
|---|---|---|
| Evidence-based digital cognitive behaviour therapyThe Evidence-based digital cognitive behaviour therapy is delivered via an internet platform during the intervention period via the platform. | Behavioural | Evidence-based digital CBT group |
| Health EducationThe Health Education therapy is delivered via an internet platform during the intervention period via the platform. | Behavioural | Health Education group |
Primary outcome
Ottawa Self-injury Inventory（OSI）
Time frame: From the date of baseline assessment (enrollment) until the date of 12-month follow-up, assessed at baseline, post-treatment (Day 1 of the week following treatment completion), and 1 month, 6 months, and 12 months after post-treatment.
Assessing the frequency and severity of nonsuicidal self-injury
5 secondary outcomes
General Anxiety Disorder-7
Time frame: Change from baseline (Day 1 of study enrollment), assessed every 2 weeks during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.
Patient Health Questionnaire-9
Time frame: Change from baseline (Day 1 of study enrollment), assessed every 2 weeks during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.
Beck's Suicide Intent Scale
Time frame: Change from baseline (Day 1 of study enrollment), assessed every week during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.
Self-harm behaviour craving visual analog scale
Time frame: Change from baseline (Day 1 of study enrollment), assessed every week during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.
Difficulties in Emotion Regulation Scale - 16-item version (DERS)
Time frame: Change from baseline (Day 1 of study enrollment), assessed at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.
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 13 Jan 2026.
- Results publication: 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.
- Results publication: PubMed 37431416Morthorst B, Olsen MH, Jakobsen JC, Lindschou J, Gluud C, Heinrichsen M, Mohl B, Rubaek L, Ojala O, Hellner C, Bjureberg J, Pagsberg AK. Internet based intervention (Emotion Regulation Individual Therapy for Adolescents) as add-on to treatment as usual versus treatment as usual for non-suicidal self-injury in adolescent outpatients: The TEENS randomised feasibility trial. JCPP Adv. 2022 Dec 3;2(4):e12115. doi: 10.1002/jcv2.12115. eCollection 2022 Dec.
- Results publication: PubMed 31512050Kaess M, Edinger A, Fischer-Waldschmidt G, Parzer P, Brunner R, Resch F. Effectiveness of a brief psychotherapeutic intervention compared with treatment as usual for adolescent nonsuicidal self-injury: a single-centre, randomised controlled trial. Eur Child Adolesc Psychiatry. 2020 Jun;29(6):881-891. doi: 10.1007/s00787-019-01399-1. Epub 2019 Sep 11.
- Results publication: PubMed 27018530Franklin JC, Fox KR, Franklin CR, Kleiman EM, Ribeiro JD, Jaroszewski AC, Hooley JM, Nock MK. A brief mobile app reduces nonsuicidal and suicidal self-injury: Evidence from three randomized controlled trials. J Consult Clin Psychol. 2016 Jun;84(6):544-57. doi: 10.1037/ccp0000093. Epub 2016 Mar 28.
- Individual participant dataSharing planned: Yes. After the publication of the research results, the data will be shared on this website and relevant journal platforms
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based digital cognitive behaviour therapy and Health Education in people with Non Suicidal Self Injury and Cognitive Behavior Therapy, run by Peking University Sixth Hospital.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yi Zhong (+86 16601555606, yizhong@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ottawa Self-injury Inventory（OSI） (time frame: From the date of baseline assessment (enrollment) until the date of 12-month follow-up, assessed at baseline, post-treatment (Day 1 of the week following treatment completion), and 1 month, 6 months, and 12 months after post-treatment.). 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 NCT07337473, 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 13 Jan 2026.