Self-harmERGT-ANCT06297824

Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm

A study testing ERGT-A in people with Self-harm and Emotion Regulation, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 to 17 years
Conditions the study is for: Self-harm, Emotion Regulation, Adolescent - Emotional Problem
What is being tested?: ERGT-A
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteSweden
Study dates: 10 Oct 2023to 10 Mar 2025
Phase: Interventional
Are there results?: None posted in the registry

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

13-17 years of age;
having engaged in deliberate self-harm (DSH)-behaviours ≥ 5 times the last year;
having engaged in ≥1 DSH episode during the past month;
having ongoing psychiatric treatment in the community;
having at least one caregiver or other significant adult, committed to participate in the parent program; and
stability of psychotropic medications

Who cannot join

a diagnosis of psychotic, bipolar I disorder or severe social anxiety disorder (SAD);
ongoing substance dependence;
the presence of co-occurring psychiatric disorders that require immediate treatment;
having an autism spectrum disorder together with borderline intellectual disability or having an intellectual disability;
insufficient understanding of the Swedish language

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Prima Barn och Vuxenpsykiatri Handen och Järva
Stockholm, Spånga, 16374

Other trials in Sweden

About this study

Official title: Can a Brief Emotion Regulation Group Therapy Help Adolescents With Deliberate Self-Harm? A Feasibility Study and a Qualitative Interview Study

A quantitative feasibility open trial (N=20) followed up by a qualitative interview study will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents.

Read the detailed description

Deliberate self-harm (DSH) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. Emotion regulation group therapy (ERGT) is a brief treatment for DSH with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present. Adaptations to ERGT will result in a 12 session long treatment for adolescents Emotion regulation group therapy for Adolescents (ERGT-A). A parallel parent group focused on strengthening parental skills will be given alongside ERGT-A (5 sessions)

Method: A quantitative feasibility open trial (N=20) with pre, post and 1 month follow-up assessments will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents.

Feasibility measures include recruitment rate, proportion beginning treatment, attrition, treatment credibility and satisfaction, negative effects, and alliance.

Preliminary effects measures include DSH, emotion regulation ability, anxiety and depression.

Method: A qualitative interview study. Using thematic analysis to explore participants' experience of ERGT-A and parent group

Conditions: Self-harm, Emotion Regulation, Adolescent - Emotional Problem
Being tested: ERGT-A
Keywords: self-harm, Emotion regulation, Group treatment, Adolescents
Medical subject headings: Self-Injurious Behavior, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ERGT-ABehavioural
Emotion regulation group therapy for adolescents

Study groups in NCT06297824
Study group	Role	What they receive
ERGT-A	Other	12 session emotion regulation treatment in group format. Psychoeducation and homework assignments. Subjects taught are the function of deliberate self-harm (DSH), functionality of emotions, negative consequences of emotional avoidance, non-avoidant emotion regulation. Receives: Behavioral: ERGT-A

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility measure, recruitment rate
Recruitment rate
Measured: through study completion, an average of 1 year
Feasibility measures, proportion included
Proportion of participants invited to participate who accepts and is included (higher = better, min 0%- max 100%)
Measured: through study completion, an average of 1 year
Feasibility measures, compliance
Compliance, no of sessions attended (>50%), (higher = better, min 0-max 10)
Measured: Pre-treatment to post-treatment (End of treatment, EOT) (12 weeks)
Feasibility measures, attrition
Attrition, percent of included participants who drops out of treatment (lower = better, min 0%- max 100%)
Measured: Pre-treatment to post-treatment EOT (12 weeks)
Feasibility measures, client satisfaction
Mean score on Client satisfaction questionnaire> 25 (higher= better, min 8-max 32)
Measured: at post-treatment EOT (12 weeks)
Feasibility measures, negative effects of treatment
Low rating on Negative effects Questionnaire (lower= better, min 0-max 20)
Measured: at post-treatment EOT (12 weeks)

Secondary outcomes (4)

Preliminary effect, self harm frequency EOT
Mean Deliberate self-harm frequency at post-treatment (min 0-max 100, lower=better)
Measured: Pre-treatment to post-treatment (EOT) (12 weeks)
Preliminary effect, self harm frequency 1MFU
Mean Deliberate self-harm frequency at post-treatment and 1MFU lower than at post-treatment (min 0-max 100, lower=better)
Measured: Post-treatment (EOT) to follow-up (4 weeks)
Preliminary effect, emotion dysregulation EOT
Mean difficulty in emotion regulation rating (DERS-16) at post-treatment lower than at pre-treatment (min 16, max 80, lower=better)
Measured: Pre-treatment to post-treatment (EOT) (12 weeks)
Preliminary effect, emotion dysregulation 1MFU
Mean difficulty in emotion regulation rating (DERS-16) at 1MFU lower than at post-treatment (min 16, max 80, lower=better)
Measured: Post-treatment (EOT) to follow-up (4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 202310 Mar 2025

First posted7 Mar 2024
Study start10 Oct 2023
Primary completion10 Mar 2025
Study completion10 Mar 2025

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: Not applicable
Intervention model: Single group
Model description: Feasibility, open trial
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06297824
Sponsor's protocol ID: 2023-04909-01
Other IDs: 2023
Acronym: ERGT-A
Status last verified: Apr 2025
First submitted: 29 Jan 2024
Last updated: 9 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Self-harm trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Can a Brief Emotion Regulation Group Therapy Help Adolescents With Deliberate Self-Harm? A Feasibility Study and a Qualitative Interview Study
ClinicalTrials.gov ID: NCT06297824
Acronym / sponsor ID: ERGT-A / 2023-04909-01
Conditions: Self-harm, Emotion Regulation, Adolescent - Emotional Problem
Keywords: self-harm, Emotion regulation, Group treatment, Adolescents
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Study start: 10 Oct 2023 (actual)
Primary completion: 10 Mar 2025 (actual)
Study completion: 10 Mar 2025 (actual)
First posted: 7 Mar 2024 (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.

A quantitative feasibility open trial (N=20) followed up by a qualitative interview study will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents.

Detailed description

Method: A quantitative feasibility open trial (N=20) with pre, post and 1 month follow-up assessments will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents.

Feasibility measures include recruitment rate, proportion beginning treatment, attrition, treatment credibility and satisfaction, negative effects, and alliance.

Preliminary effects measures include DSH, emotion regulation ability, anxiety and depression.

Method: A qualitative interview study. Using thematic analysis to explore participants' experience of ERGT-A and parent group

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Feasibility, open trial

Arm	Type	Receives
ERGT-A	Other	Behavioral: ERGT-A12 session emotion regulation treatment in group format. Psychoeducation and homework assignments. Subjects taught are the function of deliberate self-harm (DSH), functionality of emotions, negative consequences of emotional avoidance, non-avoidant emotion regulation.

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

13-17 years of age;
having engaged in deliberate self-harm (DSH)-behaviours ≥ 5 times the last year;
having engaged in ≥1 DSH episode during the past month;
having ongoing psychiatric treatment in the community;
having at least one caregiver or other significant adult, committed to participate in the parent program; and

Key exclusion criteria (5 listed)

a diagnosis of psychotic, bipolar I disorder or severe social anxiety disorder (SAD);
ongoing substance dependence;
the presence of co-occurring psychiatric disorders that require immediate treatment;
having an autism spectrum disorder together with borderline intellectual disability or having an intellectual disability;
insufficient understanding of the Swedish language

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
ERGT-AEmotion regulation group therapy for adolescents	Behavioural	ERGT-A

Primary outcome

Feasibility measure, recruitment rate
Time frame: through study completion, an average of 1 year
Recruitment rate
Feasibility measures, proportion included
Time frame: through study completion, an average of 1 year
Proportion of participants invited to participate who accepts and is included (higher = better, min 0%- max 100%)
Feasibility measures, compliance
Time frame: Pre-treatment to post-treatment (End of treatment, EOT) (12 weeks)
Compliance, no of sessions attended (>50%), (higher = better, min 0-max 10)
Feasibility measures, attrition
Time frame: Pre-treatment to post-treatment EOT (12 weeks)
Attrition, percent of included participants who drops out of treatment (lower = better, min 0%- max 100%)
Feasibility measures, client satisfaction
Time frame: at post-treatment EOT (12 weeks)
Mean score on Client satisfaction questionnaire> 25 (higher= better, min 8-max 32)
Feasibility measures, negative effects of treatment
Time frame: at post-treatment EOT (12 weeks)
Low rating on Negative effects Questionnaire (lower= better, min 0-max 20)

4 secondary outcomes

Preliminary effect, self harm frequency EOT
Time frame: Pre-treatment to post-treatment (EOT) (12 weeks)
Preliminary effect, self harm frequency 1MFU
Time frame: Post-treatment (EOT) to follow-up (4 weeks)
Preliminary effect, emotion dysregulation EOT
Time frame: Pre-treatment to post-treatment (EOT) (12 weeks)
Preliminary effect, emotion dysregulation 1MFU
Time frame: Post-treatment (EOT) to follow-up (4 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Hanna Sahlin, PhD principal investigator

Karolinska Institutet

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ERGT-A in people with Self-harm and Emotion Regulation, run by Karolinska Institutet at 1 site in Sweden.

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 6 inclusion and 5 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: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility measure, recruitment rate (time frame: through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06297824.

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 9 Apr 2025.