About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Evidence-based digital cognitive behaviour therapy
BehavioralThe Evidence-based digital cognitive behaviour therapy is delivered via an internet platform during the intervention period via the platform.
Health Education
BehavioralThe Health Education therapy is delivered via an internet platform during the intervention period via the platform.
Treatment groups
Trial outcomes
Primary outcomes
Ottawa Self-injury Inventory(OSI)
Assessing the frequency and severity of nonsuicidal self-injury
Secondary outcomes
General Anxiety Disorder-7
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
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
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
Assessment of self-harm behaviour craving in NSSI adolescent
Other outcomes
Internet Addiction Test
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.
The Pittsburgh Sleep Quality Index
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
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 0-7indicates"no clinically significant insomnia, "8-14 means"subthreshold insomnia, "15-21 is"clinical insomnia(moderate severity), "and 22-28 means"clinical insomnia(severe). "
The Morningness-Eveningness Questionnaire (MEQ)-5
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.
Locations
Sponsors and contacts
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