Evidence-based Digital CBT for Nonsuicidal Self-Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-25
SponsorPeking University Sixth Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Health Education

    Behavioral

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Evidence-based digital CBT groupExperimental treatment 1 intervention
Group B: Health Education groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ottawa Self-injury Inventory(OSI)

Assessing the frequency and severity of nonsuicidal self-injury

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 outcomes

1

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.

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.
2

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.

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.
3

Beck's Suicide Intent Scale

The total score of the BSSI ranges from 0 to 37, with higher scores indicating more severe suicidal ideation

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.
4

Self-harm behaviour craving visual analog scale

Assessment of self-harm behaviour craving in NSSI adolescent

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.

Other outcomes

1

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.

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.
2

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

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.
3

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). "

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.
4

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.

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.

Locations

This trial has no locations.

Sponsors and contacts

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