Self-HarmERANCT07720063
Group Treatment for Self-harming Adolescents and Their Parents: a Randomized Controlled Trial
A study testing Emotion Regulation Group Therapy for Self-harming Adolescents, ERA and Functional habits for mental health, FUNK in people with Self-Harm and Self-Harm, Deliberate, run by Karolinska Institutet.
Trial summary
Adolescent non-suicidal self-injury (NSSI) is common, strongly associated with psychiatric comorbidity and an increased risk of future suicide attempt. Although interventions targeting emotion regulation have been shown to reduce NSSI in both adults and adolescents few, are available within routine child and… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Self-Harm, Self-Harm, Deliberate, Self-harm Behavior
- What is being tested?
- Emotion Regulation Group Therapy for Self-harming Adolescents, ERA and Functional habits for mental health, FUNK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2026to 31 Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 13 - 17 years
- At least 5 instances of NSSI in the past year, and at least one during the past month
- ≥5 episodes of NSSI in the past year, including ≥1 in the past month
- If receiving antidepressant, central stimulants or neuroleptic medication, dose must be stable for least 6 weeks prior to inclusion
- At least one participating caregiver
- Sufficient Swedish language proficiency (adolescent and caregiver)
- Regular access to a smartphone for SMS-based assessment
Who cannot join
- Intellectual disability or a severe psychiatric disorder requiring immediate treatment (e.g., psychosis, bipolar disorder type 1, anorexia nervosa, alcohol/substance dependence) or conditions that prevent participation (e.g., severe social anxiety, selective mutism)
- Acute suicide risk (i.e., current suicide plans) or recent suicide attempt
- Previous or ongoing structured emotion regulation treatment involving at least 3 sessions during the past 12 months
- Previous or ongoing structured emotion regulation treatment (≥3 sessions within past 12 months)
- Social circumstances preventing participation or require immediate action (e.g., domestic violence, abuse and/or neglect in the family, inpatient care)
- Ongoing structured psychological treatment targeting NSSI
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomised Controlled Trial of Group Emotion Regulation for Adolescent Self-harm (the ERA-study)
Adolescent non-suicidal self-injury (NSSI) is common, strongly associated with psychiatric comorbidity and an increased risk of future suicide attempt. Although interventions targeting emotion regulation have been shown to reduce NSSI in both adults and adolescents few, are available within routine child and adolescent mental health services (CAMHS). Emotion Regulation for Adolescents (ERA), adapted from an evidence-based adult intervention is a brief group-based treatment designed to increase access to effective, evidence-based care for adolescents with NSSI. A large-scale randomised controlled trial (RCT) is needed to establish its efficacy and strengthen the evidence base for emotion regulation interventions for adolescent NSSI.
The overall aim of this project is to increase the availability of evidence-based psychological treatments for adolescent NSSI by developing and evaluating Emotion Regulation for Adolescents (ERA), a novel behavioural and acceptance-based intervention. The main objectives are to establish the efficacy, cost-effectiveness, and long-term outcomes of ERA for adolesent NSSI in two arm RCT comparing ERA with an active control condition (FUNK) as well as to investigate potential mediators such as emotion regulation and self-criticism.
Read the detailed description
Primary and secondary objectives
Primary objective:
To determine the clinical efficacy of Emotion Regulation group therapy for Adolescents (ERA) in reducing NSSI frequency, as assessed by the clinician-rated Deliberate Self-Harm Inventory, Youth Version (DSHI-Y) in adolescents with NSSI, compared to an active control condition (FUNK). The primary endpoint is 1-month post-treatment.
Secondary objectives:
- To determine the efficacy of ERA compared to an active control condition (FUNK) in reducing NSSI severity, increasing NSSI abstinence, reducing impulsive and destructive behaviours, emotion dysregulation and self-criticism anxiety and depressive symptoms; and improving general functioning at 1-month post-treatment.
- To evaluate the durability of the treatment effects at 12-month follow-up
- To investigate whether improvements in emotion regulation and reductions in self-criticism mediate reductions in NSSI at the primary endpoint (1-month post-treatment).
- To conduct a health-economic evaluation of ERA compared with FUNK at 12-month follow-up from the perspectives of the healthcare payer; healthcare system resource use, and society.
Research questions:
- Is ERA more efficacious than FUNK in reducing NSSI frequency?
- Is ERA more efficacious than FUNK in reducing NSSI severity, increasing NSSI abstinence, reducing impulsive destructive behaviours, emotion dysregulation and self-criticism, anxiety and depressive symptoms; and improving global functioning?
- Are the treatment effects of ERA maintained at 12-month follow-up?
- Do improvements in emotion regulation and reductions in self-criticism mediate effects on NSSI?
- Is ERA more cost-effective than FUNK from healthcare and societal perspectives?
- Conditions
- Self-Harm, Self-Harm, Deliberate, Self-harm Behavior, Non-Suicidal Self Injury, Non-suicidal Self-injury (NSSI)
- Being tested
- Emotion Regulation Group Therapy for Self-harming Adolescents, ERA, Functional habits for mental health, FUNK
- Keywords
- emotion regulation group therapy, non-suicidal self-injury (NSSI), randomized controlled trial
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation Group Therapy for Self-harming Adolescents, ERABehavioural
Manualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program.
Experimental: ERA Participants receive ERA a 12-week manualized group intervention, targeting NSSI. The intervention focuses on increasing adaptive emotion regulation, reducing impulsive behaviours, and increasing acceptance of difficult emotions with integrated exercises to increase self-compassion and reduce self-criticism.
Caregivers participate in a parallel five-session parent group focusing on preventing NSSI contagion, supporting emotion regulation and strengthening adaptive family communication and functioning.
Functional habits for mental health, FUNKBehavioural
Active comparator: Active Control Condition (FUNK) Participants receive a manualized active control condition FUNK consisting of: 1) ane individual family session to develop a personalized safety plan; 2) five group-based psychoeducation family sessions over 10 weeks, covering sleep, nutrition and physical activity, anxiety, depression and emotions; and 3) weekly suicide risk monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Emotion Regulation Adolescents (ERA). | Experimental | Manualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program. Receives: Behavioral: Emotion Regulation Group Therapy for Self-harming Adolescents, ERA |
| Functional habits for mental health (FUNK) | Active comparator | Active comparator: Active Control Condition (FUNK) Manualized psychoeducational group intervention with family participation, individualized safety planning, and weekly risk monitoring. Receives: Behavioral: Functional habits for mental health, FUNK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in clinician-rated scores on Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
Used to assess frequency, abstinence and severity of non-suicidal self-injury. Clinician-rated. Lower scores means better outcome.
Measured: [Time Frame: Baseline; week 12 post baseline; 1 [PRIMARY ENDPOINT]-, 6- and 12-month follow-up.]
Secondary outcomes (15)
Clinical Global Impression - Severity (CGI-S)
Used to provide an overall rating of non-suicidal self-injury severity. Clinician-rated. Range: 1-7. Lower scores mean less severe symptoms.
Measured: [Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Clinical Global Impression - Improvement (CGI-I)
Used to assess global improvement. Clinician-rated. Range: 1-7. Lower scores mean better outcome.
Measured: [Time Frame: Week 12 post baseline; 1-, 6- and 12-month follow-up.]
Children's Global Assessment Scale (CGAS)
Used to assess global psychosocial functioning. Clinician-rated. Range: 1-100. Higher scores means better outcome.
Measured: [Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
Used to assess frequency, abstinence and severity of non-suicidal self-injury. Adolescent-rated. Lower scores mean better outcome.
Measured: [Time Frame: Baseline; Mid-treatment: once every week (0-12 weeks post baseline); 1-, 6- and 12-month follow-up.]
Borderline Symptom List, supplement (BSL-23, suppl)
Used to assess frequency of impulsive self-destructive behaviors. Adolescent-rated. Lower scores mean better outcome.
Measured: [Time Frame: Baseline; Mid- treatment: once every week (0-12 weeks post baseline); 1-, 6- and 12-month follow-up.]
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
Used to assess difficulties in emotion regulation. Adolescent-rated. Parent-rated. Range: 16-80, Higher scores mean greater difficulties.
Measured: [Time Frame: Baseline, Mid-treatment: once every week (0-12 weeks post baseline), 1-,6- and 12- month follow-up.]
Everyday Adolescent Emotion Regulation-scale (EARS)
Brief measure of emotion regulation developed for this project. Adolescent-rated. Lower scores indicate better outcomes
Measured: [Time Frame: Baseline, Mid-treatment: once every week (0-12 weeks post baseline), 1-,6- and 12- month follow-up.]
Self-criticism And Kindness Scale (SAK)
Brief measure of self-criticism and self-compassion, developed for this project. Adolescent-rated. Lower scores indicate better outcomes.
Measured: [Time Frame: Baseline, week 12 post baseline, 1-,6- and 12- month follow-up.]
Short Revised Children's Anxiety and Depression Scale - Short version (RCADS-S)
Used to assess depression and anxiety symptoms. 25 items. Adolescent- and parent-rated. Range: 0-75, Lower scores mean better outcome.
Measured: [Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
The Work and Social Adjustment Scale - Youth Version (WSAS-Y)
Used to assess functional impairment. Adolescent and parent-rated. Range: 0-40. Lower scores means better outcome.
Measured: [Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
The Coping with Children's Negative Emotions Scale Adolescent Version (CANES-P).
Used to assess parents' perceived ability to cope with children's negative emotions. Parent-rated. Six subscales: minimization; punitive; emotion-focused coping; problem-focused coping; encourage emotion expression; personal distress. Range: 1-7, higher scores in minimization and punitive subsclaes mean more difficulties. Higher scores in the rest mean better outcome.
Measured: [Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]
Me as a parent (MaaP)
Questionnaire used to assess parents' beliefs about their locus of control (personal agency) and ability to self-monitor and self-manage. Four subscales: self efficacy; personal agency; self sufficiency; self management. Parent-rated. Range:4-16/ 1-4 (subscales). Higher scores mean better outcome.
Measured: [Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]
Working Alliance Inventory - Group version (WAI-S)
Used to assess perceived working alliance. Adolesent-rated. Parent-rated. Range: 0-30. Higher scores means better outcome.
Measured: [Time Frame: Mid-treatment (3 weeks post-baseline)]
The Client Satisfaction Questionnaire (CSQ-8)
Used to assess client satisfaction with treatment. Adolescent-rated. Parent-rated. Range: 8-32. Higher scores mean better outcome.
Measured: [Time Frame: 12 weeks post baseline]
Treatment Credibility and Expectancy Scale (TCES)
Questionnaire revised by the research team. Used to assess treatment credibility and expectations. Adolescent-rated. Parent-rated. Range: 0-40. Higher scores means better outcome
Measured: [Time Frame: Mid-treatment (3 weeks post-baseline)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start17 Aug 2026 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-HarmStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional Model Description: Single-blind parallel-group randomised controlled trial. Following completion of the primary endpoint assessment, participants in the active control condition may be offered crossover to ERA upon request.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Västra Götalandsregionen, Region Stockholm
- Responsible party
- Principal investigator, Hanna Sahlin, Karolinska Institutet
- Investigators
- Hanna Sahlin, PhD, Ass Professor, Principal investigator, Karolinska InstitutetMats J Olsson, Professor, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720063
- Sponsor's protocol ID
- 2025-08964-01
- Other IDs
- 2025-06882, 2025-00347, 2026-03899-02, 2025
- Acronym
- ERA
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Group Emotion Regulation for Adolescent Self-harm (the ERA-study)
- ClinicalTrials.gov ID
- NCT07720063
- Acronym / sponsor ID
- ERA / 2025-08964-01
- Conditions
- Self-Harm, Self-Harm, Deliberate, Self-harm Behavior, Non-Suicidal Self Injury, Non-suicidal Self-injury (NSSI)
- Keywords
- emotion regulation group therapy, non-suicidal self-injury (NSSI), randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Västra Götalandsregionen, Region Stockholm
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescent non-suicidal self-injury (NSSI) is common, strongly associated with psychiatric comorbidity and an increased risk of future suicide attempt. Although interventions targeting emotion regulation have been shown to reduce NSSI in both adults and adolescents few, are available within routine child and adolescent mental health services (CAMHS). Emotion Regulation for Adolescents (ERA), adapted from an evidence-based adult intervention is a brief group-based treatment designed to increase access to effective, evidence-based care for adolescents with NSSI. A large-scale randomised controlled trial (RCT) is needed to establish its efficacy and strengthen the evidence base for emotion regulation interventions for adolescent NSSI.
The overall aim of this project is to increase the availability of evidence-based psychological treatments for adolescent NSSI by developing and evaluating Emotion Regulation for Adolescents (ERA), a novel behavioural and acceptance-based intervention. The main objectives are to establish the efficacy, cost-effectiveness, and long-term outcomes of ERA for adolesent NSSI in two arm RCT comparing ERA with an active control condition (FUNK) as well as to investigate potential mediators such as emotion regulation and self-criticism.
Detailed description
Primary and secondary objectives
Primary objective:
To determine the clinical efficacy of Emotion Regulation group therapy for Adolescents (ERA) in reducing NSSI frequency, as assessed by the clinician-rated Deliberate Self-Harm Inventory, Youth Version (DSHI-Y) in adolescents with NSSI, compared to an active control condition (FUNK). The primary endpoint is 1-month post-treatment.
Secondary objectives:
- To determine the efficacy of ERA compared to an active control condition (FUNK) in reducing NSSI severity, increasing NSSI abstinence, reducing impulsive and destructive behaviours, emotion dysregulation and self-criticism anxiety and depressive symptoms; and improving general functioning at 1-month post-treatment.
- To evaluate the durability of the treatment effects at 12-month follow-up
- To investigate whether improvements in emotion regulation and reductions in self-criticism mediate reductions in NSSI at the primary endpoint (1-month post-treatment).
- To conduct a health-economic evaluation of ERA compared with FUNK at 12-month follow-up from the perspectives of the healthcare payer; healthcare system resource use, and society.
Research questions:
- Is ERA more efficacious than FUNK in reducing NSSI frequency?
- Is ERA more efficacious than FUNK in reducing NSSI severity, increasing NSSI abstinence, reducing impulsive destructive behaviours, emotion dysregulation and self-criticism, anxiety and depressive symptoms; and improving global functioning?
- Are the treatment effects of ERA maintained at 12-month follow-up?
- Do improvements in emotion regulation and reductions in self-criticism mediate effects on NSSI?
- Is ERA more cost-effective than FUNK from healthcare and societal perspectives?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional Model Description: Single-blind parallel-group randomised controlled trial. Following completion of the primary endpoint assessment, participants in the active control condition may be offered crossover to ERA upon request.
| Arm | Type | Receives |
|---|---|---|
| Emotion Regulation Adolescents (ERA). | Experimental | Behavioral: Emotion Regulation Group Therapy for Self-harming Adolescents, ERAManualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program. |
| Functional habits for mental health (FUNK) | Active comparator | Behavioral: Functional habits for mental health, FUNKActive comparator: Active Control Condition (FUNK) Manualized psychoeducational group intervention with family participation, individualized safety planning, and weekly risk monitoring. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age: 13 - 17 years
- At least 5 instances of NSSI in the past year, and at least one during the past month
- ≥5 episodes of NSSI in the past year, including ≥1 in the past month
- If receiving antidepressant, central stimulants or neuroleptic medication, dose must be stable for least 6 weeks prior to inclusion
- At least one participating caregiver
Key exclusion criteria (6 listed)
- Intellectual disability or a severe psychiatric disorder requiring immediate treatment (e.g., psychosis, bipolar disorder type 1, anorexia nervosa, alcohol/substance dependence) or conditions that prevent participation (e.g., severe social anxiety, selective mutism)
- Acute suicide risk (i.e., current suicide plans) or recent suicide attempt
- Previous or ongoing structured emotion regulation treatment involving at least 3 sessions during the past 12 months
- Previous or ongoing structured emotion regulation treatment (≥3 sessions within past 12 months)
- Social circumstances preventing participation or require immediate action (e.g., domestic violence, abuse and/or neglect in the family, inpatient care)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion Regulation Group Therapy for Self-harming Adolescents, ERAManualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program. Experimental: ERA Participants receive ERA a 12-week manualized group intervention, targeting NSSI. The intervention focuses on increasing adaptive emotion regulation, reducing impulsive behaviours, and increasing acceptance of difficult emotions with integrated exercises to increase self-compassion and reduce self-criticism. Caregivers participate in a parallel five-session parent group focusing on preventing NSSI contagion, supporting emotion regulation and strengthening adaptive family communication and functioning. | Behavioural | Emotion Regulation Adolescents (ERA). |
| Functional habits for mental health, FUNKActive comparator: Active Control Condition (FUNK) Participants receive a manualized active control condition FUNK consisting of: 1) ane individual family session to develop a personalized safety plan; 2) five group-based psychoeducation family sessions over 10 weeks, covering sleep, nutrition and physical activity, anxiety, depression and emotions; and 3) weekly suicide risk monitoring. | Behavioural | Functional habits for mental health (FUNK) |
Primary outcome
Change from baseline in clinician-rated scores on Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
Time frame: [Time Frame: Baseline; week 12 post baseline; 1 [PRIMARY ENDPOINT]-, 6- and 12-month follow-up.]
Used to assess frequency, abstinence and severity of non-suicidal self-injury. Clinician-rated. Lower scores means better outcome.
15 secondary outcomes
Clinical Global Impression - Severity (CGI-S)
Time frame: [Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Clinical Global Impression - Improvement (CGI-I)
Time frame: [Time Frame: Week 12 post baseline; 1-, 6- and 12-month follow-up.]
Children's Global Assessment Scale (CGAS)
Time frame: [Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
Time frame: [Time Frame: Baseline; Mid-treatment: once every week (0-12 weeks post baseline); 1-, 6- and 12-month follow-up.]
Borderline Symptom List, supplement (BSL-23, suppl)
Time frame: [Time Frame: Baseline; Mid- treatment: once every week (0-12 weeks post baseline); 1-, 6- and 12-month follow-up.]
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
Time frame: [Time Frame: Baseline, Mid-treatment: once every week (0-12 weeks post baseline), 1-,6- and 12- month follow-up.]
Everyday Adolescent Emotion Regulation-scale (EARS)
Time frame: [Time Frame: Baseline, Mid-treatment: once every week (0-12 weeks post baseline), 1-,6- and 12- month follow-up.]
Self-criticism And Kindness Scale (SAK)
Time frame: [Time Frame: Baseline, week 12 post baseline, 1-,6- and 12- month follow-up.]
Short Revised Children's Anxiety and Depression Scale - Short version (RCADS-S)
Time frame: [Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
The Work and Social Adjustment Scale - Youth Version (WSAS-Y)
Time frame: [Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
The Coping with Children's Negative Emotions Scale Adolescent Version (CANES-P).
Time frame: [Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]
Me as a parent (MaaP)
Time frame: [Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]
Working Alliance Inventory - Group version (WAI-S)
Time frame: [Time Frame: Mid-treatment (3 weeks post-baseline)]
The Client Satisfaction Questionnaire (CSQ-8)
Time frame: [Time Frame: 12 weeks post baseline]
Treatment Credibility and Expectancy Scale (TCES)
Time frame: [Time Frame: Mid-treatment (3 weeks post-baseline)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanna Sahlin, PhD, Ass Professor principal investigator
Karolinska Institutet
Mats J Olsson, Professor study chair
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Regulation Group Therapy for Self-harming Adolescents, ERA and Functional habits for mental health, FUNK in people with Self-Harm and Self-Harm, Deliberate, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Sahlin, PhD, Ass Prof (+46706005920, Hanna.Sahlin@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in clinician-rated scores on Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7) (time frame: [Time Frame: Baseline; week 12 post baseline; 1 [PRIMARY ENDPOINT]-, 6- and 12-month follow-up.]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.