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NCT Number: NCT06297824

Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm

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.

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.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prima Barn och Vuxenpsykiatri Handen och Järva

Stockholm, Spånga, 16374, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ERGT-A

Behavioral

Emotion regulation group therapy for adolescents

Primary outcomes

  1. Feasibility measure, recruitment rate

    Time frame: through study completion, an average of 1 year

    Recruitment rate

  2. 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%)

  3. 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)

  4. 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%)

  5. 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)

  6. 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)

Secondary outcomes

  1. Preliminary effect, self harm frequency EOT

    Time frame: Pre-treatment to post-treatment (EOT) (12 weeks)

    Mean Deliberate self-harm frequency at post-treatment (min 0-max 100, lower=better)

  2. Preliminary effect, self harm frequency 1MFU

    Time frame: Post-treatment (EOT) to follow-up (4 weeks)

    Mean Deliberate self-harm frequency at post-treatment and 1MFU lower than at post-treatment (min 0-max 100, lower=better)

  3. Preliminary effect, emotion dysregulation EOT

    Time frame: Pre-treatment to post-treatment (EOT) (12 weeks)

    Mean difficulty in emotion regulation rating (DERS-16) at post-treatment lower than at pre-treatment (min 16, max 80, lower=better)

  4. Preliminary effect, emotion dysregulation 1MFU

    Time frame: Post-treatment (EOT) to follow-up (4 weeks)

    Mean difficulty in emotion regulation rating (DERS-16) at 1MFU lower than at post-treatment (min 16, max 80, lower=better)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: ERGT-A

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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