- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04243603
Effects of Internet-based ERITA Added to TAU in Young People With Non-Suicidal Self-Injury (TEENS) Feasibility Trial
May 21, 2021 updated by: Britt Reuter Morthorst, Mental Health Services in the Capital Region, Denmark
Treatment Effects of Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) Added to Treatment as Usual in Young People With Non-Suicidal Self-Injury - (TEENS) Feasibility Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Non-suicidal self-injury has disseminated almost epidemically through the last decades in young persons.
There is no evidence of any experimental treatment for non-suicidal self-injury in adolescents, superior to treatment as usual.
Patients with stigmatizing illness such as non-suicidal self-injury may find internet-based interventions more acceptable.
The study is a feasibility trial, with a randomization procedure in a parallel group design.
Patients will be recruited from Child- and Adolescent Mental Health Services (age 13 to 17 years).
The experimental intervention is internet-based, and therapist guided; ERITA consists of online Emotion Regulation Individual Therapy for Adolescents (ERITA) as add-on to treatment as usual.
Treatment as usual is provided by multidisciplinary teams in nine outpatient clinics within Child and Adolescent Mental Health Services in the Capital Region of Denmark.
Feasibility of recruitment and trial procedures will be monitored as well as explorative clinical outcomes.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2100
- Team for Self-injury, Child and Adolescent Mental Health Services, B195
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥ 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Internet-based ERITA-DK
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.
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Please see description of experimental arm (arm one)
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Active Comparator: Treatment as Usual (TAU)
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.
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Please see description of experimental arm (arm one)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion of follow-up
Time Frame: End of treatment at 12 weeks
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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.
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End of treatment at 12 weeks
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The fraction of eligible participants who consent to inclusion and randomization
Time Frame: End of treatment at 12 weeks
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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.
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End of treatment at 12 weeks
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Compliance
Time Frame: End of treatment at 12 weeks
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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.
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End of treatment at 12 weeks
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Non-suicidal self-injury as explorative primary clinical outcome
Time Frame: End of treatment at 12 weeks
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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)
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End of treatment at 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life as explorative secondary clinical outcomes
Time Frame: End of treatment at 12 weeks
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Quality of life at 12 weeks, assessed with Kidscreen-10.
5-point Likert scale, range: not at all, a little, modearte, much, very much.
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End of treatment at 12 weeks
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Symptoms of depression, anxiety and stress as explorative secondary clinical outcomes
Time Frame: End of treatment at 12 weeks
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Symptoms of depression, anxiety and stress at 12 weeks, assessed with Depression Anxiety Stress Scale (DASS-21).
4-point Likert scale, range: did not apply to me, applied to me to some degree, applied to me to a considerable degree, applied to me much/most of the time.
Totale range for subscores: 0-42.
Higher scores reflects worse outcome.
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End of treatment at 12 weeks
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Non-suicidal self-injury as dichotomous variables as explorative secondary clinical outcome
Time Frame: End of treatment at 12 weeks
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Non-suicidal self-injury as dichotomous variables (Yes/No)
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End of treatment at 12 weeks
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Number of sick days the last month as explorative secondary clinical outcome
Time Frame: End of treatment at 12 weeks
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Number of sick days the last month
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End of treatment at 12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difficulties in emotion regulation as further explorative clinical outcome
Time Frame: At end of treatment and once a week for 12 weeks
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Difficulties in emotion regulation, assessed weekly during 12 weeks with Difficulties in Emotion Regulation Scale (DERS-16).
5-point Likert scale, range: almost never, some times, half of the time, most of the time, all the time.
Total scores range from 16 to 80, with higher scores reflecting grater levels of emotion dysregulation.
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At end of treatment and once a week for 12 weeks
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Indirect self-destructive behaviours as further explorative clinical outcome
Time Frame: End of treatment at 12 weeks
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Indirect self-destructive behaviours at 12 weeks, assessed with Borderline Symptom List (BSL-supplement).
5-point Likert scale, range: not at all, once, 2-3 times, 4-6 times, daily or more often.
Total scores range from 0-44 and higher scores reflect worse outcome.
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End of treatment at 12 weeks
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Suicidal ideations, plans and actions as further explorative clinical outcome
Time Frame: End of treatment at 12 weeks
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Suicidal ideations, plans and actions at 12 weeks, assessed with Columbia (C-SSRS).
Dichotomous outcome yes/no; if yes intensity is rated on a 5-point Likert scale, total score range: 2-25.
Higher scores reflect worse outcome.
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End of treatment at 12 weeks
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Parents' ability to cope with children's negative emotions as further explorative clinical outcome
Time Frame: After week six and week 12
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Adolescent's perception of Parents' ability to cope with children's negative emotions at 6 weeks and 12 weeks, assessed with The Coping with Children's Negative Emotions Scale (CCNES-APP).
7-point Likert scale, Range from very unlikely to very likely.
Six Sub scales with total score range: 0-42.
The sub scale are inversely related.
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After week six and week 12
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Parents' perceived ability to cope with children's negative emotions as further explorative clinical outcome
Time Frame: After week six and week 12
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Parents' perceived ability to cope with children's negative emotions at 6 weeks and 12 weeks, assessed with The Coping with Children's Negative Emotions Scale Adolescent (CCNES-A).
7-point Likert scale, Range from very unlikely to very likely.
Six Sub scales with total score range: 0-42.
The sub scale are inversely related.
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After week six and week 12
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Adverse Events as further explorative clinical outcome
Time Frame: After week 4, 8, and 12
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Adverse Events 4, 8 and 12 weeks assessed with Negative Effects Questionnaire (NEQ).
Dichotomous outcomes as yes/no; if yes then a 5-point Likert scale of the impact, range not at all, a little, moderately, much, very much.
The total score range 0-80.
Higher scores reflect worse outcome.
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After week 4, 8, and 12
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Strengths and difficulties as further explorative clinical outcome
Time Frame: After week 4, 8, and 12
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Strengths and difficulties assessed by Strengths and difficulties questionnaire (SDQ) at 4, 8, and 12 weeks.
3-point Likert scale, range: doesn't fit, fits moderately, fits very much.
Total score range 0-40.
Sub scales of strengths and difficulties that are inversely related.
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After week 4, 8, and 12
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Working alliance with online therapist as further explorative clinical outcome
Time Frame: After week 4, 8, and 12
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Working alliance with online therapist assessed with Working Alliance Inventory (WAI-SR).
5-point Likert scale, range: seldom, some times, fairly often, very often, always.
Total score range 12-60.
Higher scores reflect higher working alliance/better outcome.
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After week 4, 8, and 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Anne Katrine Pagsberg, Professor, Child & Adolescent Mental Health Services Capital Region of Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2020
Primary Completion (Actual)
January 22, 2021
Study Completion (Actual)
January 22, 2021
Study Registration Dates
First Submitted
January 16, 2020
First Submitted That Met QC Criteria
January 24, 2020
First Posted (Actual)
January 28, 2020
Study Record Updates
Last Update Posted (Actual)
May 24, 2021
Last Update Submitted That Met QC Criteria
May 21, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-19042904
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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