Non-suicidal Self-injury (NSSI)NSSI-DPTNCT07683234
Non-Suicidal Self-Injury Digital Psychotherapy Trial
A study testing digital psychotherapy and Treatment as Usual (TAU) in people with Non-suicidal Self-injury (NSSI), run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
The goal of this randomized, parallel-controlled clinical trial is to investigate multi-dimensional biomarkers (blood, brain imaging, clinical information, and symptom assessment) in adolescents with Non-Suicidal Self-Injury (NSSI) and to evaluate the therapeutic and prognostic effects of a novel digital psychological… Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Non-suicidal Self-injury (NSSI)
- What is being tested?
- digital psychotherapy and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 31 Dec 2028
- 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
- Diagnosis of Non-Suicidal Self-Injury (NSSI) according to DSM-5, confirmed by two psychiatrists with senior professional titles.
- Adolescents aged 12-25 years, any gender.
- Willing to participate voluntarily and with good insight.
Who cannot join
- Presence of severe mental disorders (e.g., schizophrenia, schizoaffective disorder, substance use disorder, intellectual disability).
- Major central nervous system diseases (e.g., history of head trauma or infection, intracranial tumor, cerebrovascular disease, epilepsy).
- History of major physical diseases (e.g., malignancy, myocardial infarction, liver or kidney dysfunction).
- History of abuse of sedative-hypnotics, alcohol, or other psychoactive substances.
- History of suicide attempt, current high suicide risk, or current suicidal behavior/ideation.
- Pregnancy or breastfeeding.
About this study
Official title: A Novel Digital Psychotherapy Intervention for Non-Suicidal Self-Injury in Adolescents: A Randomized Controlled Trial
The goal of this randomized, parallel-controlled clinical trial is to investigate multi-dimensional biomarkers (blood, brain imaging, clinical information, and symptom assessment) in adolescents with Non-Suicidal Self-Injury (NSSI) and to evaluate the therapeutic and prognostic effects of a novel digital psychological intervention plus treatment as usual (TAU) compared to TAU alone in this population.
The main question[s] it aims to answer [is/are]:
Read more
What are the distinct biomarker profiles (e.g., inflammatory, endocrine, neuroimaging) associated with adolescent NSSI? Does the novel digital psychological intervention (based on CBT and DBT) combined with TAU lead to a higher clinical response rate (≥25% reduction in NSSI scale score from baseline) at 8 and 16 weeks compared to TAU alone?
If there is a comparison group: Researchers will compare the digital intervention plus TAU group to the TAU-only group to see if adding the digital intervention significantly improves NSSI symptom reduction, depressive symptoms (HAMD-24 response rate), and long-term outcomes.
Participants will:
Undergo baseline assessments including blood sampling (inflammatory and endocrine markers, routine biochemistry), structural and resting-state functional MRI, and clinical scales (e.g., HAMD, HAMA).
Use a smartphone app for 8 weeks, completing 16 self-guided digital modules (2 per week, 15-25 minutes each) based on CBT and DBT, covering topics such as NSSI psychoeducation, safety planning, emotion regulation, distress tolerance, mindfulness, and relapse prevention.
Complete daily Ecological Momentary Assessment (EMA) questionnaires (1-2 minutes) on self-harm urge intensity, mood, and coping skills used; receive Ecological Momentary Intervention (EMI) when high urge is detected.
Receive low-intensity remote coaching (one 20-30 min onboarding call, then two brief contacts per week via text/call/email) to support app adherence.
Attend follow-up assessments at week 4, week 8 (intervention endpoint), and week 16 (study endpoint) for repeated clinical and outcome measures.
- Conditions
- Non-suicidal Self-injury (NSSI)
- Being tested
- digital psychotherapy, Treatment as Usual (TAU)
- Keywords
- Non-Suicidal Self-Injury (NSSI), adolescents, digital psychological intervention, randomized controlled trial (RCT), dialectical behavior therapy (DBT)
- 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.
digital psychotherapyBehavioural
The experimental intervention is an 8-week, self-guided digital psychological intervention delivered via a smartphone application, added to treatment as usual (TAU). It is based on cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT). The intervention includes:
16 interactive modules (2 per week, 15-25 minutes each) covering NSSI psychoeducation, safety planning, emotion regulation, distress tolerance, mindfulness, interpersonal effectiveness, and relapse prevention.
Daily ecological momentary assessment (EMA) of mood and self-harm urges (1-2 minutes/day).
Automated ecological momentary intervention (EMI) triggered when high-intensity urges are reported, providing real-time coping skills and safety plan access.
Digital safety plan and skill-logging features. Low-intensity remote coaching (one 20-30 minute onboarding call, then two brief contacts per week via text/phone/email) to support app adherence.
Treatment as usual (TAU) consists of standard clinical care provided at the Department of Psychiatry, The Fourth Affiliated Hospital, Zhejiang University School of Medicine. TAU may include medication management (e.g., antidepressants or mood stabilizers as clinically indicated), routine psychiatric follow-up visits, supportive counseling, and any other non-experimental interventions prescribed by the treating psychiatrist. No additional digital psychological intervention is given. Participants in the TAU-alone group do not have access to the study app but will undergo the same assessment schedule (baseline, week 4, week 8, week 16) as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| digital psychological intervention group | Experimental | Participants in the experimental group will receive the novel digital psychological intervention plus treatment as usual (TAU). The digital intervention is delivered via a smartphone app over 8 weeks and includes:
16 self-guided modules (2 per week, 15-25 minutes each) based on cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT), covering NSSI psychoeducation, emotion regulation, distress tolerance, mindfulness, safety planning, and relapse prevention.
Daily ecological momentary assessment (EMA) of mood and self-harm urges, with automated ecological momentary intervention (EMI) triggered when high urges are detected.
Low-intensity remote coaching (one onboarding call and two brief weekly contacts) to support adherence. Receives: Behavioral: digital psychotherapy |
| treatment as usual | Active comparator | TAU is provided as per standard clinical practice at the study site. Receives: Drug: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Rate
Proportion of participants with a ≥25% reduction from baseline in the Non-Suicidal Self-Injury (NSSI) scale score. The NSSI scale has a total score ranging from 0 to 124, with higher scores indicating greater severity of NSSI behaviors.
Measured: At week 8 (intervention endpoint) and week 16 (study endpoint)
Secondary outcomes (1)
Depressive Symptom Response Rate
Proportion of participants with a ≥25% reduction from baseline in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score. The HAMD-24 scale has a total score ranging from 0 to 74, with higher scores indicating greater severity of depression.
Measured: At week 8 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-suicidal Self-injury (NSSI)Studies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683234
- Sponsor's protocol ID
- KY-2026-051
- Acronym
- NSSI-DPT
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Digital Psychotherapy Intervention for Non-Suicidal Self-Injury in Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07683234
- Acronym / sponsor ID
- NSSI-DPT / KY-2026-051
- Conditions
- Non-suicidal Self-injury (NSSI)
- Keywords
- Non-Suicidal Self-Injury (NSSI), adolescents, digital psychological intervention, randomized controlled trial (RCT), dialectical behavior therapy (DBT)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Jul 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.
The goal of this randomized, parallel-controlled clinical trial is to investigate multi-dimensional biomarkers (blood, brain imaging, clinical information, and symptom assessment) in adolescents with Non-Suicidal Self-Injury (NSSI) and to evaluate the therapeutic and prognostic effects of a novel digital psychological intervention plus treatment as usual (TAU) compared to TAU alone in this population.
The main question[s] it aims to answer [is/are]:
What are the distinct biomarker profiles (e.g., inflammatory, endocrine, neuroimaging) associated with adolescent NSSI? Does the novel digital psychological intervention (based on CBT and DBT) combined with TAU lead to a higher clinical response rate (≥25% reduction in NSSI scale score from baseline) at 8 and 16 weeks compared to TAU alone?
If there is a comparison group: Researchers will compare the digital intervention plus TAU group to the TAU-only group to see if adding the digital intervention significantly improves NSSI symptom reduction, depressive symptoms (HAMD-24 response rate), and long-term outcomes.
Participants will:
Undergo baseline assessments including blood sampling (inflammatory and endocrine markers, routine biochemistry), structural and resting-state functional MRI, and clinical scales (e.g., HAMD, HAMA).
Use a smartphone app for 8 weeks, completing 16 self-guided digital modules (2 per week, 15-25 minutes each) based on CBT and DBT, covering topics such as NSSI psychoeducation, safety planning, emotion regulation, distress tolerance, mindfulness, and relapse prevention.
Complete daily Ecological Momentary Assessment (EMA) questionnaires (1-2 minutes) on self-harm urge intensity, mood, and coping skills used; receive Ecological Momentary Intervention (EMI) when high urge is detected.
Receive low-intensity remote coaching (one 20-30 min onboarding call, then two brief contacts per week via text/call/email) to support app adherence.
Attend follow-up assessments at week 4, week 8 (intervention endpoint), and week 16 (study endpoint) for repeated clinical and outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| digital psychological intervention group | Experimental | Behavioral: digital psychotherapyParticipants in the experimental group will receive the novel digital psychological intervention plus treatment as usual (TAU). The digital intervention is delivered via a smartphone app over 8 weeks and includes: 16 self-guided modules (2 per week, 15-25 minutes each) based on cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT), covering NSSI psychoeducation, emotion regulation, distress tolerance, mindfulness, safety planning, and relapse prevention. Daily ecological momentary assessment (EMA) of mood and self-harm urges, with automated ecological momentary intervention (EMI) triggered when high urges are detected. Low-intensity remote coaching (one onboarding call and two brief weekly contacts) to support adherence. |
| treatment as usual | Active comparator | Drug: Treatment as Usual (TAU)TAU is provided as per standard clinical practice at the study site. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of Non-Suicidal Self-Injury (NSSI) according to DSM-5, confirmed by two psychiatrists with senior professional titles.
- Adolescents aged 12-25 years, any gender.
- Willing to participate voluntarily and with good insight.
Key exclusion criteria (6 listed)
- Presence of severe mental disorders (e.g., schizophrenia, schizoaffective disorder, substance use disorder, intellectual disability).
- Major central nervous system diseases (e.g., history of head trauma or infection, intracranial tumor, cerebrovascular disease, epilepsy).
- History of major physical diseases (e.g., malignancy, myocardial infarction, liver or kidney dysfunction).
- History of abuse of sedative-hypnotics, alcohol, or other psychoactive substances.
- History of suicide attempt, current high suicide risk, or current suicidal behavior/ideation.
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 |
|---|---|---|
| digital psychotherapyThe experimental intervention is an 8-week, self-guided digital psychological intervention delivered via a smartphone application, added to treatment as usual (TAU). It is based on cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT). The intervention includes: 16 interactive modules (2 per week, 15-25 minutes each) covering NSSI psychoeducation, safety planning, emotion regulation, distress tolerance, mindfulness, interpersonal effectiveness, and relapse prevention. Daily ecological momentary assessment (EMA) of mood and self-harm urges (1-2 minutes/day). Automated ecological momentary intervention (EMI) triggered when high-intensity urges are reported, providing real-time coping skills and safety plan access. Digital safety plan and skill-logging features. Low-intensity remote coaching (one 20-30 minute onboarding call, then two brief contacts per week via text/phone/email) to support app adherence. | Behavioural | digital psychological intervention group |
| Treatment as Usual (TAU)Treatment as usual (TAU) consists of standard clinical care provided at the Department of Psychiatry, The Fourth Affiliated Hospital, Zhejiang University School of Medicine. TAU may include medication management (e.g., antidepressants or mood stabilizers as clinically indicated), routine psychiatric follow-up visits, supportive counseling, and any other non-experimental interventions prescribed by the treating psychiatrist. No additional digital psychological intervention is given. Participants in the TAU-alone group do not have access to the study app but will undergo the same assessment schedule (baseline, week 4, week 8, week 16) as the experimental group. | Drug | treatment as usual |
Primary outcome
Clinical Response Rate
Time frame: At week 8 (intervention endpoint) and week 16 (study endpoint)
Proportion of participants with a ≥25% reduction from baseline in the Non-Suicidal Self-Injury (NSSI) scale score. The NSSI scale has a total score ranging from 0 to 124, with higher scores indicating greater severity of NSSI behaviors.
1 secondary outcome
Depressive Symptom Response Rate
Time frame: At week 8 and week 16
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 6 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing digital psychotherapy and Treatment as Usual (TAU) in people with Non-suicidal Self-injury (NSSI), run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
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 6 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 6 Jul 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?
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?
Clinical Response Rate (time frame: At week 8 (intervention endpoint) and week 16 (study endpoint)). 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 6 Jul 2026.