Effect of Evidence-based Digital Cognitive Behavior Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Peking University Sixth Hospital
- Enrollment
- 100
- Primary Endpoint
- Ottawa Self-injury Inventory（OSI）
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Evidence-based digital CBT group
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.
Intervention: Evidence-based digital cognitive behaviour therapy (Behavioral)
Health Education group
Participants will receive health education for 6 weeks, adjunctive to treatment as usual, as provided in the community or research group.
Intervention: Health Education (Behavioral)
Outcomes
Primary Outcomes
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.
Assessing the frequency and severity of nonsuicidal self-injury
Secondary Outcomes
- 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.)
- 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.)
- 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.)
Investigators
Yi Zhong
Peking University
Peking University Sixth Hospital