Not yet recruiting NCT07337473
Evidence-based Digital CBT for Nonsuicidal Self-Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Evidence-based digital cognitive behaviour therapy, Health Education.
- Who it may be relevant to
- Registry conditions: Non Suicidal Self Injury, Cognitive Behavior Therapy. Basic parameters: 12 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Evidence-based Digital Cognitive Behavior Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial
Overview
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.
Interventions
- Behavioral Evidence-based digital cognitive behaviour therapy
The Evidence-based digital cognitive behaviour therapy is delivered via an internet platform during the intervention period via the platform. - Behavioral Health Education
The Health Education therapy is delivered via an internet platform during the intervention period via the platform.
Primary outcome measures
- 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.]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 37440232
- 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) PMID 37431416
- 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
- 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
Identifiers
NCT: NCT07337473 · PekingUSH 20251020