Non-suicidal Self-injury (NSSI)NCT07848620
Acceptance and Commitment Therapy-Based Chatbot for Non-suicidal Self-Injury in Adolescents
A study testing ACT-Based Chatbot in people with Non-suicidal Self-injury (NSSI), run by Central China Normal University.
Trial summary
The purpose of this study is to evaluate the feasibility and effectiveness of a self-guided digital Acceptance and Commitment Therapy (ACT) intervention for adolescents who engage in non-suicidal self-injury (NSSI). Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Non-suicidal Self-injury (NSSI)
- What is being tested?
- ACT-Based Chatbot
- 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
- 8 Oct 2026to 1 Mar 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be adolescents aged 10-19 years (Sawyer et al., 2018).
- Have engaged in five or more self-injurious behaviors within the past year and meet the DSM-5 diagnostic criteria for Non-Suicidal Self-Injury (NSSI) (American Psychiatric Association, 2013).
- Provide assent to participate, with written informed consent obtained from both the adolescent and their legal guardian.
- Have access to a smartphone capable of completing the study procedures, including logging into the study mini-program to complete the self-guided intervention and sending and receiving text messages.
Who cannot join
- Have an intellectual disability or other significant cognitive, neurodevelopmental, or visual impairment that may interfere with their ability to complete the study procedures.
- Have a severe physical illness.
- Be experiencing an acute episode of a severe mental disorder, such as a manic episode of bipolar disorder.
- Have experienced suicidal ideation or a suicide attempt within the past month.
- Do not have access to a smartphone or are unable to use one to complete the study procedures.
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: Acceptance and Commitment Therapy-Based Chatbot for Non-suicidal Self-Injury in Adolescents: A Randomized Controlled Trial
The purpose of this study is to evaluate the feasibility and effectiveness of a self-guided digital Acceptance and Commitment Therapy (ACT) intervention for adolescents who engage in non-suicidal self-injury (NSSI). The intervention is delivered through a mobile-based program and consists of seven modules focusing on acceptance, cognitive defusion, present-moment awareness, self-as-context, values, and committed action. Adolescents will complete the intervention over a 3-week period and will be randomly assigned to the intervention or control condition. The study will examine whether the digital ACT intervention can reduce NSSI and improve psychological flexibility and other indicators of mental health, including depression, anxiety, hope, and emotion regulation.
Read the detailed description
Background: Nonsuicidal self-injury (NSSI) is highly prevalent among adolescents. Acceptance and Commitment Therapy (ACT) has shown promise, but access to traditional therapy is limited. Chatbot-based interventions offer a scalable alternative.
Objective: This randomized controlled trial aims to examine the efficacy of an ACT-based chatbot in reducing NSSI among adolescents.
Methods: Participants will be randomized 1:1 to the intervention group (ACT-based chatbot) or a waitlist control group. The intervention lasts three weeks, with modules covering acceptance, cognitive defusion, values, and committed action. Assessments will be conducted at baseline, post-intervention, 1-month and 3-months follow-up. Primary outcome is the frequency of NSSI episodes. Secondary outcomes include NSSI severity,anxiety symptoms and depressive symptoms.
Analysis: Intention-to-treat analysis will be used. Mixed-effects models will assess changes over time between groups.
- Conditions
- Non-suicidal Self-injury (NSSI)
- Being tested
- ACT-Based Chatbot
- Keywords
- Internet-Based Intervention, Chatbot, Randomized Controlled Trial, Non-suicidal self-injury (NSSI), adolescent, Acceptance and commitment therapy
- 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.
ACT-Based ChatbotBehavioural
The intervention is a fully automated, text-based chatbot delivered via a mobile application or web platform. It is based on the core processes of Acceptance and Commitment Therapy (ACT). Over three weeks, participants will engage with the chatbot for approximately 10 minutes per day, 3 days per week.
The chatbot delivers structured modules covering: (1) acceptance and willingness to experience difficult emotions; (2) cognitive defusion techniques; (3) present-moment awareness; (4) self-as-context; (5) values clarification; and (6) committed action. The chatbot includes safety protocols that provide crisis resources and emergency contact information if participants report severe self-harm urges or suicidal ideation.
The intervention is designed to be self-guided, with no human therapist involvement, to ensure scalability and accessibility.
| Study group | Role | What they receive |
|---|---|---|
| "ACT-Based Chatbot" Group | Experimental | Not described Receives: Behavioral: ACT-Based Chatbot |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of non-suicidal self-injury behaviors
The Behavior subscale of the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ) will be used to assess adolescents' non-suicidal self-injury behaviors and functions. The Behavior subscale consists of 12 items, rated on a 5-point Likert scale ranging from 0 (never) to 4 (always).
Measured: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
Secondary outcomes (2)
Depression
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depressive symptoms. The questionnaire consists of nine items, each rated from 0 to 3. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
Anxiety
The Generalized Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptoms. The scale consists of seven items rated on a 4-point scale: 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
Measured: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start8 Oct 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-suicidal Self-injury (NSSI)Studies 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
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group (ACT-based chatbot) or the waitlist control group. Both groups will be assessed at baseline, post-intervention, and follow-up. Participants in the waitlist control group will receive the same intervention after the study period ends.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central China Normal University
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Mental Health Centre
- Responsible party
- Principal investigator, Zhihong Ren, Central China Normal University
- Investigators
- Zhihong Ren, PhD, Principal investigator, Central China Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848620
- Sponsor's protocol ID
- CCNU-IRB-202603054A
- Other IDs
- 2024YFC3308400
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Jia J, Du X, Duan T, Ye Z, Hu J, Lu T, Liu X, Zhou Z, Yu X, Ren Z. Trends in non-suicidal self-injury among adolescents: A global cross-temporal meta-analysis, 2007-2023. Psychol Med. 2025 Nov 11;55:e340. doi: 10.1017/S0033291725102134.
PubMed 41216717
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy-Based Chatbot for Non-suicidal Self-Injury in Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07848620
- Acronym / sponsor ID
- CCNU-IRB-202603054A
- Conditions
- Non-suicidal Self-injury (NSSI)
- Keywords
- Internet-Based Intervention, Chatbot, Randomized Controlled Trial, Non-suicidal self-injury (NSSI), adolescent, Acceptance and commitment therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central China Normal UniversityUniversity, hospital or other
- Collaborators
- Wuhan Mental Health Centre
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 30 Sep 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 purpose of this study is to evaluate the feasibility and effectiveness of a self-guided digital Acceptance and Commitment Therapy (ACT) intervention for adolescents who engage in non-suicidal self-injury (NSSI). The intervention is delivered through a mobile-based program and consists of seven modules focusing on acceptance, cognitive defusion, present-moment awareness, self-as-context, values, and committed action. Adolescents will complete the intervention over a 3-week period and will be randomly assigned to the intervention or control condition. The study will examine whether the digital ACT intervention can reduce NSSI and improve psychological flexibility and other indicators of mental health, including depression, anxiety, hope, and emotion regulation.
Detailed description
Background: Nonsuicidal self-injury (NSSI) is highly prevalent among adolescents. Acceptance and Commitment Therapy (ACT) has shown promise, but access to traditional therapy is limited. Chatbot-based interventions offer a scalable alternative.
Objective: This randomized controlled trial aims to examine the efficacy of an ACT-based chatbot in reducing NSSI among adolescents.
Methods: Participants will be randomized 1:1 to the intervention group (ACT-based chatbot) or a waitlist control group. The intervention lasts three weeks, with modules covering acceptance, cognitive defusion, values, and committed action. Assessments will be conducted at baseline, post-intervention, 1-month and 3-months follow-up. Primary outcome is the frequency of NSSI episodes. Secondary outcomes include NSSI severity,anxiety symptoms and depressive symptoms.
Analysis: Intention-to-treat analysis will be used. Mixed-effects models will assess changes over time between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group (ACT-based chatbot) or the waitlist control group. Both groups will be assessed at baseline, post-intervention, and follow-up. Participants in the waitlist control group will receive the same intervention after the study period ends.
| Arm | Type | Receives |
|---|---|---|
| "ACT-Based Chatbot" Group | Experimental | Behavioral: ACT-Based Chatbot |
| Control group | No intervention | – |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Be adolescents aged 10-19 years (Sawyer et al., 2018).
- Have engaged in five or more self-injurious behaviors within the past year and meet the DSM-5 diagnostic criteria for Non-Suicidal Self-Injury (NSSI) (American Psychiatric Association, 2013).
- Provide assent to participate, with written informed consent obtained from both the adolescent and their legal guardian.
- Have access to a smartphone capable of completing the study procedures, including logging into the study mini-program to complete the self-guided intervention and sending and receiving text messages.
Key exclusion criteria (5 listed)
- Have an intellectual disability or other significant cognitive, neurodevelopmental, or visual impairment that may interfere with their ability to complete the study procedures.
- Have a severe physical illness.
- Be experiencing an acute episode of a severe mental disorder, such as a manic episode of bipolar disorder.
- Have experienced suicidal ideation or a suicide attempt within the past month.
- Do not have access to a smartphone or are unable to use one to complete the study procedures.
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 |
|---|---|---|
| ACT-Based ChatbotThe intervention is a fully automated, text-based chatbot delivered via a mobile application or web platform. It is based on the core processes of Acceptance and Commitment Therapy (ACT). Over three weeks, participants will engage with the chatbot for approximately 10 minutes per day, 3 days per week. The chatbot delivers structured modules covering: (1) acceptance and willingness to experience difficult emotions; (2) cognitive defusion techniques; (3) present-moment awareness; (4) self-as-context; (5) values clarification; and (6) committed action. The chatbot includes safety protocols that provide crisis resources and emergency contact information if participants report severe self-harm urges or suicidal ideation. The intervention is designed to be self-guided, with no human therapist involvement, to ensure scalability and accessibility. | Behavioural | "ACT-Based Chatbot" Group |
Primary outcome
Severity of non-suicidal self-injury behaviors
Time frame: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
The Behavior subscale of the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ) will be used to assess adolescents' non-suicidal self-injury behaviors and functions. The Behavior subscale consists of 12 items, rated on a 5-point Likert scale ranging from 0 (never) to 4 (always).
2 secondary outcomes
Depression
Time frame: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
Anxiety
Time frame: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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 30 Sep 2026.
- Background: PubMed 41216717Jia J, Du X, Duan T, Ye Z, Hu J, Lu T, Liu X, Zhou Z, Yu X, Ren Z. Trends in non-suicidal self-injury among adolescents: A global cross-temporal meta-analysis, 2007-2023. Psychol Med. 2025 Nov 11;55:e340. doi: 10.1017/S0033291725102134.
- Individual participant dataSharing planned: Yes
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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.
Zhihong Ren, PhD principal investigator
Central China Normal University
Questions about this trial
What is this clinical trial studying?
A study testing ACT-Based Chatbot in people with Non-suicidal Self-injury (NSSI), run by Central China Normal University.
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 5 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 30 Sep 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 Jiaojiao Jia (China code +86 15308622827, jiajiaojiao@mails.ccnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of non-suicidal self-injury behaviors (time frame: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.). 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 NCT07848620, which also lists 1 linked publication.
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 30 Sep 2026.