Internet Delivered ERITA for Nonsuicidal Self-Injury

NCT03353961 | Completed

• 1 other identifier: 2017/10 BIP ERITA
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.

Conditions

Nonsuicidal Self-injury

Keywords

NSSI

Outcome Measures

Primary Outcomes (1)

• Deliberate Self-Harm Inventory Youth version (DSHI-Y)

  Frequency of nonsuicidal self-injury

  Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended

Secondary Outcomes (7)

• Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)

  Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended

• Difficulties in Emotion Regulation Scale - 36 item version (DERS)

  Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

• the 21-item Depression Anxiety Stress Scales (DASS-21)

  Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

• Borderline Symptom List Supplement

  Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended

• Acceptance and Action Questionnaire

  Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Other Outcomes (10)

• Short version of the Experiences in Close Relationships Scale - Revised Child version

  Change from baseline, once every second week during treatment (0-12 weeks after baseline)

• Generalised Anxiety Disorder 7-item scale

  Change from baseline, once every second week during treatment (0-12 weeks after baseline)

• Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version

  Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Study Arms (2)

Adjunctive Internet-delivered ERITA

EXPERIMENTAL

Participants will receive 11 weeks of internet-delivered emotion regulation individual therapy with therapist support adjunctive to treatment as usual as provided in the community. The caregiver(s) will receive 6 modules of internet-delivered parent program with therapist support.

Behavioral: Emotion regulation individual therapy

Treatment as usual

ACTIVE COMPARATOR

Participants will receive treatment as usual for 11 weeks of treatment as usual as provided in the community.

Behavioral: Treatment as usual

Interventions

Emotion regulation individual therapy BEHAVIORAL

The emotion regulation individual therapy is delivered via an internet platform and includes therapist contact several times per week via the platform.

Adjunctive Internet-delivered ERITA

Treatment as usual BEHAVIORAL

Treatment as usual as provided in the community.

Treatment as usual

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≥ 5 nonsuicidal self-injury episodes past year
• ≥ 1 nonsuicidal self-injury episodes past month
• having at least one parent who committed to participate in the parent program

You may not qualify if:

• Severe suicidal ideation
• a diagnosis of psychotic or bipolar I disorder or ongoing (past month) substance dependence
• the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)
• insufficient understanding of the Swedish language

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (2)

Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council

Stockholm, 113 64, Sweden

Location

Karolinska Institutet

Stockholm, 113 64, Sweden

Location

Related Publications (4)

• Ojala O, Sjoblom K, Hesser H, Hedman-Lagerlof E, Hellner C, Bjureberg J. Parents' coping with their adolescent's negative emotions following internet-delivered emotion regulation therapy for adolescents with non-suicidal self-injury disorder: a secondary analysis of a randomised clinical trial. BMJ Ment Health. 2026 Jan 29;29(1):e302039. doi: 10.1136/bmjment-2025-302039.

  PMID: 41611448 DERIVED

• Ponten M, Flygare O, Bellander M, Karemyr M, Nilbrink J, Hellner C, Ojala O, Bjureberg J. Comparison between clinician and machine learning prediction in a randomized controlled trial for nonsuicidal self-injury. BMC Psychiatry. 2024 Dec 18;24(1):904. doi: 10.1186/s12888-024-06391-x.

  PMID: 39695442 DERIVED

• Bjureberg J, Ojala O, Hesser H, Habel H, Sahlin H, Gratz KL, Tull MT, Claesdotter Knutsson E, Hedman-Lagerlof E, Ljotsson B, Hellner C. Effect of Internet-Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2322069. doi: 10.1001/jamanetworkopen.2023.22069.

  PMID: 37440232 DERIVED

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.

  PMID: 33677832 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Clara Hellner, PhD, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 27, 2017
• Study Start: November 20, 2017
• Primary Completion: January 7, 2021
• Study Completion: October 17, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)