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NCT Number: NCT07755774

Psychological Treatment for Adolescents With Self-injury Within Intensive Mental Health Outpatient Services: Randomized Controlled Pilot Trial

The overarching aim of this study is to develop and evaluate a new blended treatment format, which combines face-to-face and digital treatment components, for Emotion Regulation Individual Therapy for Adolescents (ERITA). This brief, transdiagnostic, and blended treatment targeting nonsuicidal self-injury (NSSI) - referred to as blended ERITA - will be specifically designed for adolescents with NSSI and low levels of functioning within intensive outpatient psychiatric services. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Sweden

Location contact

Johan Bjureberg, PhD

SUB_INVESTIGATOR

Olivia Ojala, PhD

PRINCIPAL_INVESTIGATOR

Samantha Khoo

CONTACT

[email protected]

+4602355460

About this study

NSSI is a growing health crisis among youth and the strongest risk factor for suicide attempts. Scalable and evidence-based treatments are needed but lacking. We have recently shown that a brief digital treatment, Internet-delivered ERITA, can be efficacious compared to treatment as usual only.

However, digital treatment is not suitable for everyone. Adolescents with low levels of functioning have trouble engaging in text-based therapy independently from home. A blended format, which combines in-person and online treatment, may enhance effectiveness; therapists can tailor delivery of material, and adolescents can access the skills when necessary.

This project aims to develop and evaluate a blended version of ERITA - blended ERITA - for adolescents with low levels of functioning. The specific objectives of this pilot study are:

Primary:

  • Evaluate the feasibility of the project (i.e., data proportion at the primary endpoint, adherence, treatment completion, and therapist time)
  • Evaluate acceptability of blended ERITA (i.e., satisfaction, credibility, negative effects)

Secondary:

  • Provide explorative data on the utility of blended ERITA and treatment as usual.

This project is sponsored by the Swedish Research Council for Health, Working life, and Welfare (number 2025-01507).

The protocol including statistical analysis plan is found at: https://osf.io/e6wjq/overview

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 12-17 years old
  • At least one NSSI episode in the past three months
  • A parent willing to engage in the parent program
  • Global functioning corresponding to a rating ≤50 of the Children's Global Assessment Scale (CGAS)

Exclusion criteria

  • Immediate suicide risk
  • Social problems needing immediate intervention (e.g., violence within the family)
  • Other psychiatric disorder or symptoms requiring immediate treatment (e.g., severe anorexia nervosa, acute psychosis, severe substance abuse)
  • Ongoing dialectical behavior therapy for adolescents

Treatment and study plan

Blended ERITA

Behavioral

Blended ERITA is an acceptance-based behavioral therapy. The goal of ERITA is to reduce self-injury through learning and using other ways to regulate emotions. ERITA includes both an adolescent treatment and a separate parent course. The adolescent treatment includes skills training in emotional awareness, impulse control, emotional acceptance, emotional willingness, emotional modulation effectiveness and flexibility, validation, and valued direction. The parent course includes skills training in emotional awareness, validation, self-validation, and behavioral activation. The adolescent treatment is 11 modules, and the parent course is six. The modules include text, videos, and audio resources. The family and therapist decide on how to combine sessions with digital material based on preferences and needs.

Treatment as Usual (TAU)

Behavioral

Treatment as usual (TAU) will constitute treatment for NSSI according to local clinical guidelines.

Concomitant Care

Other

Participants are free to receive concomitant care (counselling or medication) in addition to self-injury treatment according to their needs during the trial.

Primary outcomes

  1. Degree of participation in data collection

    Time frame: One-month post-treatment

    Proportion of adolescents completing the primary clinical outcome, Deliberate Self-harm Inventory - Youth version, either through interview or self-report questionnaire at one-month post-treatment.

  2. Treatment completion

    Time frame: Post-treatment (week 20)

    Proportion of adolescents completing ≥ six ERITA modules. Only in the experimental condition. Clinician-rated

  3. Therapist time

    Time frame: Post-treatment (week 20)

    Therapists will report time for having sessions with adolescents and/or parents or giving feedback on the digital platform. Only in the experimental condition.

  4. Credibility/Expectancy Questionnaire (CEQ)

    Time frame: Week 2 (after first week in treatment)

    CEQ measures treatment credibility and expectancy. Scale points range from 0-9, and 0-100%, where higher scores indicate greater credibility and expectancy. Self-rated by adolescents. Only in the experimental condition.

  5. Emotion regulation therapy adherence checklist

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

    This checklist measures therapist adherence to emotion regulation therapy. Adapted to be suitable for therapy with adolescents. Only in the experimental condition.

  6. Client Satisfaction Questionnarie (CSQ)

    Time frame: Post-treatment (week 20)

    The CSQ measures satisfaction with treatment. This scale has 8 items and a summary score ranging from 8 to 32, with higher scores indicating greater treatment satisfaction. Self-reported (adolescents and parents).

  7. Adverse events

    Time frame: Post-treatment and through study completion, an average of 1 year

    A scale where participants are asked to report, describe, and rate the discomfort/impact of any negative effects or adverse events caused by their participation in the treatment. Participants rate the impact of potential adverse events when it happened and today on a scale from 1 to 4, where a higher score indicates greater impact. Self-reported (adolescents and parents). Adverse events will be recorded by PI throughout the treatment period.

Secondary outcomes

  1. Deliberate Self-harm Inventory - Youth version (DSHI-Y)

    Time frame: One- and three-months post-treatment

    The DSHI-Y is a youth-adaptation of the DSHI and measures the six most common NSSI methods. The primary clinical outcome will be the proportion of treatment remission. Remission will be defined as the absence of NSSI in the past month and measured dichotomously (yes/no). The primary data source will be blinded assessor-rated DSHI-Y. If these data are missing, self-reported DSHI-Y will be used.

  2. Deliberate Self-harm Inventory - Youth version (DSHI-Y)

    Time frame: Baseline, one-, and three-months post-treatment

    The DSHI-Y measures the frequency of the most common NSSI behaviors. Change in NSSI frequency from baseline to respective follow-up will be a secondary outcome. The primary outcome measure will be the clinician-rated DSHI-Y. In cases where clinician ratings are unavailable, the self-rated DSHI-Y will be used.

  3. Difficulties in Emotion Regulation Scale - 16 items version (DERS-16)

    Time frame: Baseline, one-, and three-months post-treatment

    The DERS-16 measures difficulties in emotion regulation. The total score ranges from 16 to 80, with higher scores indicating greater difficulties. Self-rated (adolescent and parent).

  4. Clinical Global Assessment Scale (CGAS)

    Time frame: Baseline, one-, and three-months post-treatment

    The CGAS measures global functioning on a single item ranging from 1 to 100, with a higher value indicating better functioning. Clinician-rated.

  5. Borderline Symptom List - Behavior Supplement (BSL-Supplement)

    Time frame: Baseline, one-, and three-months post-treatment

    The BSL supplement measures the frequency of self-destructive behaviors. We will measure behaviors of self-harm, suicide attempt, binge eating, self-induced vomiting, high-risk activities, getting drunk, substance use, medication misuse, outbreaks of anger/physical attacks and impulsive/shameful sexual encounters, resulting in a total score between 0 to 40 where a higher score indicates greater frequency of self-destructive behaviors. Self-rated (adolescent).

  6. Child Health Utility 9D Index (CHU-9D)

    Time frame: Baseline, one-, and three-months post-treatment

    The CHU-9D measures health related quality of life. The scale has 9 items with a summary score between 9 and 45, where a higher score indicates greater health-related quality of life. Self-rated (adolescent).

  7. Revised Child Anxiety and Depression Scale-Short Version (RCADS-25)

    Time frame: Baseline, one-, and three-months post-treatment

    The RCADS-25 measures symptoms of depression and anxiety in children and adolescents. This version has 25 items with a total score between 0 and 75, with higher scores indicating greater levels of symptoms. Self-rated (adolescent).

  8. Coping with Children's Negative Emotions Scale - Adolescent version (CCNES-A)

    Time frame: Baseline, one-, and three-months post-treatment

    The CCNES-A measures parental coping in response to adolescents' negative emotions. The CCNES-A consists of nine hypothetical scenarios accompanied by six types of responses (i.e., emotion focused, problem-focused, minimization, punitive, expressive encouragement, and distress responses). Separate summary scores are calculated per subscale (type of response) and ranges from 1 to 7, with higher scores indicating greater usage of a certain parental coping style. Self-rated (parent and adolescent).

  9. The Work and Social Adjustment Scale -Youth version (WSAS-Y)

    Time frame: Baseline, one-, and three-months post-treatment

    The WSAS-Y measures functional impairment in school, everyday life, friends and social life, recreation and hobbies, and family and close relationships.This 5-item scale generates a summary score between 0 and 40, with higher scores indicating greater impairment. Youths rate their own impairment. Self-rated.

  10. The Work and Social Adjustment Scale - Parent version (WSAS-P)

    Time frame: Baseline, one-, and three-months post-treatment

    The WSAS-P measures functional impairment in school, everyday life, friends and social life, recreation and hobbies, and family and close relationships.This 5-item scale generates a summary score between 0 and 40, with higher scores indicating greater impairment. Parents rate their youth's impairment. Self-rated.

Other outcomes

  1. Credibility/Expectancy Questionnaire (CEQ) - 1 item version

    Time frame: Baseline

    CEQ measures treatment credibility and expectancy. This version of the scale has 1 item ranging from 0 to 100, with higher scores indicating greater credibility/expectancy. Self-rated (adolescent).

  2. Columbia-Suicide Severity Rating Scale (C-SSRS) - 6 item version

    Time frame: Baseline

    The C-SSRS - 6 item version measures the frequency and severity of suicidal ideation and behaviors. Clinician-rated.

  3. Care consumption

    Time frame: From enrollment to three-months post-treatment

    Degree and type of care consumption as registered by the health care. Registry data from the local Stockholm register for Child and Adolescent Mental Health Services.

  4. Inventory of Statements About Self-injury (ISAS)

    Time frame: Baseline

    ISAS measures frequency, function, age of onset, experience of, and willingness to stop engaging in self-injury. There are 39 items describing common functions of self-injury. Participants are asked to rate if a certain function applies to them, by marking the statement as "Not relevant", "Partly relevant", or "Very relevant". Self-rated (adolescent).

  5. Demographical and clinical background data

    Time frame: Baseline

    Current mental health disorders, age, previous and current treatment. Clinician-rated. Gender and sexual orientation. Self-rated (adolescent). Country of birth, living situation, parental occupation, parental academic degree, and parental history of mental health disorders. Self-report (parent)

Study contacts

Contact information is provided by the study sponsor or research team.

Olivia Ojala, PhD

CONTACT

[email protected]

+46761426565

Samantha Khoo

CONTACT

[email protected]

+4670-2355460

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

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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