Psychological Treatment for Adolescents With Self-injury Within Intensive Mental Health Outpatien… (NCT07755774) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Psychological Treatment for Adolescents With Self-injury Within Intensive Mental Health Outpatient Services: Randomized Controlled Pilot Trial
Sweden40 participantsStarted 2026-09
Plain-language summary
The overarching aim of this study is to develop and evaluate a new blended treatment format, which combines face-to-face and digital treatment components, for Emotion Regulation Individual Therapy for Adolescents (ERITA). This brief, transdiagnostic, and blended treatment targeting nonsuicidal self-injury (NSSI) - referred to as blended ERITA - will be specifically designed for adolescents with NSSI and low levels of functioning within intensive outpatient psychiatric services. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 12-17 years old
* At least one NSSI episode in the past three months
* A parent willing to engage in the parent program
* Global functioning corresponding to a rating ≤50 of the Children's Global Assessment Scale (CGAS)
Exclusion Criteria:
* Immediate suicide risk
* Social problems needing immediate intervention (e.g., violence within the family)
* Other psychiatric disorder or symptoms requiring immediate treatment (e.g., severe anorexia nervosa, acute psychosis, severe substance abuse)
* Ongoing dialectical behavior therapy for adolescents
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Degree of participation in data collection
Timeframe: One-month post-treatment
2
Treatment completion
Timeframe: Post-treatment (week 20)
3
Therapist time
Timeframe: Post-treatment (week 20)
4
Credibility/Expectancy Questionnaire (CEQ)
Timeframe: Week 2 (after first week in treatment)
5
Emotion regulation therapy adherence checklist
Timeframe: Through study completion, an average of 1 year
6
Client Satisfaction Questionnarie (CSQ)
Timeframe: Post-treatment (week 20)
7
Adverse events
Timeframe: Post-treatment and through study completion, an average of 1 year