Cognitive Behavior Therapy, Non Suicidal Self Injury
Conditions
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.
Interventions
BEHAVIORALEvidence-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.
BEHAVIORALHealth Education
The Health Education therapy is delivered via an internet platform during the intervention period via the platform.
Sponsors
Peking University Sixth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ottawa Self-injury Inventory（OSI） | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety. |
| 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. | The Patient Health Questionnaire-9 (PHQ-9) is a widely used brief screening tool that can assist both in identifying individuals with major depression disorder, as well as assessing the severity of depressive symptoms. |
| 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. | The total score of the BSSI ranges from 0 to 37, with higher scores indicating more severe suicidal ideation |
| 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. | Assessment of self-harm behaviour craving in NSSI adolescent |
| 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. | Difficulties in emotion regulation. Higher scores indicate more difficulties. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties |
| 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. | Respondents rate each element of the questionnaire using Likert-type scales. Responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. Scores are tallied and can be compared both to scores obtained at a different phase of treatment and to the scores of other individuals. Though developers point out that their chosen cutoff scores have not been validated, they offer a few guidelines for interpreting scale results: a total score of 0-7indicatesno clinically significant insomnia, 8-14 meanssubthreshold insomnia, 15-21 isclinical insomnia(moderate severity), and 22-28 meansclinical insomnia(severe). |
| The Morningness-Eveningness Questionnaire (MEQ)-5 | 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. | Assess morningness and eveningness. Questions are framed in a preferential manner, where the respondent is asked to indicate when, for example, he/she would prefer to wake up or start sleep, rather than when he/she actually does. |
| Dysfunctional Beliefs and Attitudes about Sleep (DBAS) | 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 Dysfunctional Beliefs about Sleep Scale - short version (DBAS-16) is a self-report questionnaire designed to assess beliefs, attitudes, and misconceptions about sleep that may contribute to insomnia. It consists of 16 items that measure various cognitive distortions related to sleep, such as unrealistic expectations, misattributions about insomnia, and concerns about the consequences of poor sleep |
| 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 IAT total score is the sum of the ratings given by the examinee for the 20 item responses. Each item is rated on a 5-point scale ranging from 0 to 5. The maximum score is 100 points. The higher the score is, the higher is the severity of your problem. Total scores that range from 0 to 30 points are considered to reflect a normal level of Internet usage; scores of 31 to 49 indicate the presence of a mild level of Internet addiction; 50 to 79 reflect the presence of a moderate level; and scores of 80 to 100 indicate a severe dependence upon the Internet. |
Contacts
Primary ContactYi Zhong
Outcome results
None listed