Effects of Internet-based ERITA Added to TAU in Young People With Non-Suicidal Self-Injury (TEENS) Feasibility Trial

NCT04243603 | Completed

• 1 other identifier: H-19042904
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

There has been a significant increase in non-suicidal self-injury the last decades especially among young people and treatment initiative are sparse. We aim to assess the feasibility of methods, procedures, and safety of internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as add on to treatment as usual (TAU) in 13-17-year-old patients with non-suicidal self-injury referred to psychiatric services.

Conditions

Non-suicidal Self-injury

Keywords

Non-suicidal Self-injury; Internet-based intervention

Outcome Measures

Primary Outcomes (4)

• Completion of follow-up

  Completion of follow-up will be defined as completing at least one clinical outcome (non-suicidal self-injury events) at end of intervention. If the number participants with completed outcomes is 26 out of 30, the fraction will be 87%, 95% CI 75% to 99%. A follow-up fraction of 87% or more will be acceptable for a future trial while a fraction below 75% will impose serious problems of interpreting the trial result in a future large pragmatic trial.

  End of treatment at 12 weeks

• The fraction of eligible participants who consent to inclusion and randomization

  We will determine the fraction of potential participants as the number of eligible persons compared to the number of randomized persons. If the number of participants randomized out of the number of eligible persons is 30 out of 75, the fraction will be 40%, 95% confidence interval (CI) will be: 29% to 51%. A randomization fraction of 29% or more will be acceptable for a future trial, while a fraction below 29% will impose serious problems of recruitment for a future large pragmatic trial.

  End of treatment at 12 weeks

• Compliance

  Compliance with the experimental intervention will be defined as completing at least six of 12 ERITA sessions. ERITA will automatically register time for login and save the exercises that have been completed. If the number of compliant experimental participants is 11 out of 15, the fraction will be 73%, 95% CI 51% to 96%. A compliance fraction of 51% or more will be acceptable for a future trial while a fraction below 51% will impose serious problems of interpreting the trial result in a future large pragmatic trial.

  End of treatment at 12 weeks

• Non-suicidal self-injury as explorative primary clinical outcome

  Non-suicidal self-injury, assessed at baseline and end of therapy (12 weeks) by blinded outcome assessment by phone with Deliberate Self-Harm Inventory (DSHI-Y)

  End of treatment at 12 weeks

Secondary Outcomes (4)

• Quality of life as explorative secondary clinical outcomes

  End of treatment at 12 weeks

• Symptoms of depression, anxiety and stress as explorative secondary clinical outcomes

  End of treatment at 12 weeks

• Non-suicidal self-injury as dichotomous variables as explorative secondary clinical outcome

  End of treatment at 12 weeks

• Number of sick days the last month as explorative secondary clinical outcome

  End of treatment at 12 weeks

Other Outcomes (8)

• Difficulties in emotion regulation as further explorative clinical outcome

  At end of treatment and once a week for 12 weeks

• Indirect self-destructive behaviours as further explorative clinical outcome

  End of treatment at 12 weeks

• Suicidal ideations, plans and actions as further explorative clinical outcome

  End of treatment at 12 weeks

Study Arms (2)

Internet-based ERITA-DK

EXPERIMENTAL

ERITA is a youth-adapted version of Emotion Regulation Group Therapy (ERGT), based on cognitive behavioral therapy (CBT), dialectical behavior therapy (DBT), and Acceptance and Commitment Therapy (ACT), which encounters emotional recognition and regulation, crisis strategies and skills training. The ERITA intervention is provided as add-on to TAU and consists of 12 weeks, manualized, therapist guided internet-based therapy. The intervention also provides six modules for the parents focusing on NSSI and other risk-taking behaviors, emotional awareness, and validation skills. The participants must complete one module every week while the parents must complete a module every second week. A mobile app is available to complement the online treatment. The app includes reminders of homework and skills and allows to report on both self-destructive behaviors and impulses daily.

Behavioral: Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Child and Adolescent Mental Health Services (CAMHS) offer specialized treatment for children and adolescents. TAU encounters a variety of clinical treatment and assessment offers, representing a highly inhomogeneous group of treatments, for instance: Pharmacological treatment, Family-Based Treatment (FBT), Cognitive Behavioral Therapy, supportive counselling and psychoeducation. Throughout the trial course the treatment responsibility is handled by clinicians providing TAU.

Behavioral: Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK)

Interventions

Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK) BEHAVIORAL

Please see description of experimental arm (arm one)

Internet-based ERITA-DK; Treatment as Usual (TAU)

Eligibility Criteria

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

You may qualify if:

• ≥ 5 non-suicidal self-injury episodes in the past year and ≥ 1 non-suicidal self-injury episodes in the past month (DSM-5 criteria for a diagnosis of non-suicidal self-injury disorder in terms of frequency of NSSI).
• Age-appropriate literacy.
• Having at least one parent committing to participate in the parent program.
• Informed consent from parents/legal caretakers.

You may not qualify if:

• Imminent suicidal risk assessed by clinicians during routine screening procedure (rated as no risk, elevated risk, imminent risk) in need of admission or other life saving strategies.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Team for Self-injury, Child and Adolescent Mental Health Services, B195

Copenhagen, Ø, 2100, Denmark

Location

Related Publications (3)

• Olsen MH, Morthorst B, Pagsberg AK, Heinrichsen M, Mohl B, Rubaek L, Bjureberg J, Simonsson O, Lindschou J, Gluud C, Jakobsen JC. An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial. Trials. 2021 Jul 16;22(1):456. doi: 10.1186/s13063-021-05406-2.

  PMID: 34271984 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

• Morthorst B, Rubaek L, Lindschou J, Jakobsen JC, Gluud C, Bjureberg J, Hellner C, Mohl B, Pagsberg AK. An internet-based emotion regulation intervention versus no intervention for nonsuicidal self-injury in adolescents: study protocol for a feasibility trial. Pilot Feasibility Stud. 2021 Feb 6;7(1):44. doi: 10.1186/s40814-021-00785-4.

  PMID: 33549128 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Anne Katrine Pagsberg, Professor

  Child & Adolescent Mental Health Services Capital Region of Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, a blinding of participants and therapists (intervention providers) is not possible. Blinded outcome assessment and data management will be performed. Statistical analyses will be performed by two blinded statisticians presenting independent reports. Based on the two blinded conclusions, two abstracts will be written and published (on a website).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Single-center, feasibility trial including a randomization procedure in a parallel group design with blinded outcome assessment.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 28, 2020
• Study Start: May 11, 2020
• Primary Completion: January 22, 2021
• Study Completion: January 22, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)