Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm

Not Applicable

Completed

• Conditions: Emotion Regulation; Self-harm; Adolescent - Emotional Problem
• Interventions: Behavioral: ERGT-A

• Registration Number: NCT06297824
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

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

Study Timeline

• Study Start: 2023-10-10
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-07
• Primary Completion: 2025-03-10
• Study Completion: 2025-03-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ERGT-A	ERGT-A	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.

Primary Outcome Measures

Name	Time	Method
Feasibility measures, attrition	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, compliance	Pre-treatment to post-treatment (End of treatment, EOT) (12 weeks)	Compliance, no of sessions attended (\>50%), (higher = better, min 0-max 10)
Feasibility measure, recruitment rate	through study completion, an average of 1 year	Recruitment rate
Feasibility measures, client satisfaction	at post-treatment EOT (12 weeks)	Mean score on Client satisfaction questionnaire\> 25 (higher= better, min 8-max 32)
Feasibility measures, proportion included	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, negative effects of treatment	at post-treatment EOT (12 weeks)	Low rating on Negative effects Questionnaire (lower= better, min 0-max 20)

Secondary Outcome Measures

Name	Time	Method
Preliminary effect, emotion dysregulation EOT	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)
Preliminary effect, self harm frequency 1MFU	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)
Preliminary effect, emotion dysregulation 1MFU	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)
Preliminary effect, self harm frequency EOT	Pre-treatment to post-treatment (EOT) (12 weeks)	Mean Deliberate self-harm frequency at post-treatment (min 0-max 100, lower=better)

Trial Locations

Locations (1)

Prima Barn och Vuxenpsykiatri Handen och Järva; 🇸🇪 Stockholm, Spånga, Sweden