Acceptance and Commitment Therapy-Based Chatbot for Non-suicidal Self-Injury in Adolescents

NCT07848620 | Not Yet Recruiting

• 2 other identifiers: CCNU-IRB-202603054A2024YFC3308400
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Non-suicidal Self-injury (NSSI)

Keywords

Internet-Based Intervention; Chatbot; Randomized Controlled Trial; Non-suicidal self-injury (NSSI); adolescent; Acceptance and commitment therapy

Outcome Measures

Primary Outcomes (1)

• 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).

  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 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 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.

Other Outcomes (5)

• Psychological flexibility

  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.

• Hope

  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.

• Emotion Regulation Strategies

  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.

Study Arms (2)

"ACT-Based Chatbot" Group

EXPERIMENTAL

Behavioral: ACT-Based Chatbot

Control group

NO INTERVENTION

Interventions

ACT-Based Chatbot BEHAVIORAL

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.

"ACT-Based Chatbot" Group

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central China Normal University: lead
• Wuhan Mental Health Centre: collaborator

Related Publications (1)

• 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.

  PMID: 41216717 BACKGROUND

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Zhihong Ren, PhD

  Central China Normal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaojiao Jia

CONTACT

China code +86 15308622827; jiajiaojiao@mails.ccnu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Dean

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF