Evidence-based Digital CBT for Nonsuicidal Self-Injury

NCT07337473 | Not Yet Recruiting DMC

• 1 other identifier: PekingUSH 20251020
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non Suicidal Self Injury; Cognitive Behavior Therapy

Outcome Measures

Primary Outcomes (1)

• Ottawa Self-injury Inventory（OSI）

  Assessing the frequency and severity of nonsuicidal self-injury

  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

  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

  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

  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

  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)

  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.

Other Outcomes (5)

• Internet Addiction Test

  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.

• The Pittsburgh Sleep Quality Index

  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.

• Insomnia Severity Index

  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.

Study Arms (2)

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.

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.

Behavioral: Health Education

Interventions

Evidence-based digital cognitive behaviour therapy BEHAVIORAL

The Evidence-based digital cognitive behaviour therapy is delivered via an internet platform during the intervention period via the platform.

Evidence-based digital CBT group

Health Education BEHAVIORAL

The Health Education therapy is delivered via an internet platform during the intervention period via the platform.

Health Education group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• nonsuicidal self-injury episodes past year
• nonsuicidal self-injury episodes past month having at least one parent who committed to participate in the program

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University Sixth Hospital: lead

Related Publications (4)

• 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.

  PMID: 37440232 RESULT

• Morthorst 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.

  PMID: 37431416 RESULT

• Kaess 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.

  PMID: 31512050 RESULT

• Franklin 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.

  PMID: 27018530 RESULT

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Yi Zhong

CONTACT

+86 16601555606; yizhong@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: January 13, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL