Treating Self-criticism in Adolescents: a Study With Single-case Experimental Design (NCT05247190) | Clinical Trial Compass
CompletedNot Applicable
Treating Self-criticism in Adolescents: a Study With Single-case Experimental Design
Sweden19 participantsStarted 2021-12-03
Plain-language summary
In this pilot study, the effect of a group intervention targeting self-criticism in adolescents in a clinical child- and adolescent psychiatric outpatient setting will be examined using a single-case experimental design (AB). Participants will be randomized to multiple baseline with weekly measures. Our primary outcomes, measured weekly, are self-criticism, nonsuicidal self-injury and symptoms of depression and anxiety, as well as an individually chosen behavior driven by self-criticism. Secondary outcomes are self-compassion, psychological flexibility, quality of life and functioning. In addition to the weekly administered questionnaires, before and after measures, and 3- and 6-month follow-up will be collected. After the treatment, participants will also be interviewed about their experiences of targeting self-criticism.
Who can participate
Age range
15 Years – 18 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:
* Patient at the child- and adolescent psychiatric clinic in Linköping, Sweden.
* 15 to 18 years
* an adequate understanding of the Swedish language
* cognitively capable of giving informed consent
* scoring 26 or above on subscale "Inadequate self" and 8.5 or above on subscale "Hated Self" on questionnaire Forms of Self-Criticism and Self-Reassuring Scale (FSCRS)
* the treatment is transdiagnostic so all diagnoses are included (See exclusion criteria for exceptions).
Exclusion Criteria:
* severe anorexia, BMI ≤ 16
* ongoing substance abuse
* diagnosed intellectual disability
* needing interpreter for translation of Swedish language
* participants who cannot give informed consent
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
Self-criticism
Timeframe: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months