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Self-Harm, DeliberateNCT07450105

Intensive Dialectical Behavior Therapy for Self-Harm and Suicidal Behavior in Youth: A Pilot Study

A study testing Intensive Dialectical Behavior Therapy in people with Self-Harm, Deliberate and Suicidal Behavior, run by Haukeland University Hospital at 1 site in Norway.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The prevalence of self-harm and suicidal behavior among adolescents has increased dramatically over the past two decades-a fourfold rise that represents both a severe personal burden and a substantial public health challenge. Read more about this study

Who is it for?
Ages 14 to 17 years
What is being tested?
Intensive Dialectical Behavior Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteNorway
Study dates
2 Mar 2026to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 14-18 years
  • Current or previous self-harm within the past six months
  • Current suicidal behavior (suicidal ideation or at least one suicide attempt in the past six months)
  • Meets at least three criteria for Borderline Personality Disorder (BPD) according to DSM-5, or meets the criterion for self-destructive behavior in addition to at least two subthreshold criteria, assessed using the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (29)
  • Sufficient Norwegian language proficiency to participate in group-based treatment
  • One parent or another close adult able to participate together with the adolescent

Who cannot join

  • Intellectual disability
  • Significant learning or language difficulties
  • Autism spectrum disorder
  • Anorexia nervosa
  • Psychotic disorder
  • Substance use disorder

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Norway1 site
  • Dept. of child and adolescent psychiatry, Haukeland University Hospital

    Bergen

Other trials in Norway

About this study

The prevalence of self-harm and suicidal behavior among adolescents has increased dramatically over the past two decades-a fourfold rise that represents both a severe personal burden and a substantial public health challenge. Dialectical Behavior Therapy for Adolescents (DBT-A) is the gold-standard treatment; however, the standard 20-week format is resource-intensive and time-consuming, which limits accessibility. An intensive 4-week DBT (I-DBT) program has been developed that may improve access and reach a larger number of adolescents. The investigators now seek to evaluate its feasibility and preliminary outcomes.

The investigators will assess the feasibility of I-DBT in two to three adolescent groups comprising a total of 8-12 participants and their caregivers in spring and autumn 2026, examining recruitment, feasibility, and outcome measures such as self-harm, suicide attempts, acute hospital admissions, depression, and quality of life, as well as treatment dropout. The investigators aim to use the feedback to make necessary adjustments before broader testing of the I-DBT intervention.

Read the detailed description

Introduction Burden of self-harm and suicidal behavior. Self-harming behavior (self-poisoning or self-injury regardless of the degree of suicidal intent) and attempted suicide among adolescents have increased fivefold over the last two decades. A meta-analysis including data on 12- to 18-year-olds from 41 countries reported a lifetime prevalence of 16.9 % for self-harming behavior, with higher rates among girls than boys. An increase from 4.1% to 16.2% in self-harm prevalence from 2002 to 2017/18 is also reported among Norwegian adolescents.

Self-harm and suicidal behavior in adolescents result from a complex interplay between genetic, biological, psychiatric, psychological, social, and cultural factors. Self-harm often starts and peaks in early adolescence (i.e., 13-16 years). Earlier onset and higher frequency of self-harm increase the risk of a more severe trajectory, and a history of repetitive hospital-treated self-harm is one of the most prominent predictors of suicide. Psychiatric disorders, particularly mood disorders, stress-related disorders, and emergent traits consistent with borderline personality disorder (BPD), are associated with an increased risk for self-harm in adolescents. Adolescents with repetitive self-harm and suicidal behavior have substantial medical and mental health service use. It is estimated that this group of patients generates 24% of the total costs of psychiatric inpatient treatments across age groups. The personal, familial, and societal costs of self-harm and suicidal behavior are considerable. This underscores the importance of accessible, evidence-based treatments for adolescents presenting with self-harm and suicidal behavior, such as Dialectical Behavior Therapy (DBT).

Dialectical behavior therapy (DBT) for self-harm and suicidal behavior. DBT was initially developed to treat women with Borderline Personality Disorder (BPD) and suicidal behavior and is widely recommended as the first-line treatment of BPD, self-harming behavior, suicidal behavior, and emotional dysregulation given its robust empirical support. DBT is manualized and based on the premise that some individuals are more sensitive to and experience emotions more intensely than others. To manage intense emotions, more emotionally sensitive persons tend to react in more extreme and impulsive manners (e.g., self-harm). A lack of awareness of emotional experiences interferes with the development of more effective coping strategies. DBT focuses on providing individuals with skills (e.g., mindfulness, distress tolerance, interpersonal effectiveness, emotion regulation) to develop an awareness and acceptance of distressing internal experiences and to use these skills to overcome pervasive emotion dysregulation. Examples of some of the distress tolerance skills are to use distraction, self-soothing, and guidelines for accepting reality; for interpersonal effectiveness to learn how to keep relationship and keeping self-respect; and for emotion regulation to learn steps for increasing positive emotions and changing emotional states.

Dialectical behavior therapy for adolescents (DBT-A). DBT-A is adapted for adolescents aged 14-18 years and prioritizes self-harm, suicidal behavior, and borderline symptoms as the primary targets for the intervention (16-18). Secondary targets include reducing the need for emergency hospital admission, treatment dropout, and comorbid psychiatric symptoms, as well as improving daily functioning. Standard DBT-A comprises 20 weekly individual sessions, concurrent participation in skills training multifamily groups (with 4-6 youth in a group) with combined youth and parent/caregiver sessions, along with telephone consultations as needed. Importantly, the family is integrated into therapy through a holistic approach that reinforces skills and helps to decrease maladaptive behaviors by focusing on the behavioral and communicative patterns of both the adolescent and the parent/caregiver. DBT-A has empirical support for reducing self-harming and suicidal behaviors and BPD symptoms in adolescents and is regarded as the gold standard for this group of patients.

The Department of Child and Adolescent Psychiatry (PBU), Helse Bergen, has offered standard DBT-A since 2015. The DBT-A team receives referrals from the seven child and adolescent mental health outpatient clinics (CAMHS) in Helse Bergen, assesses eligibility criteria for DBT-A, offers up to four sessions for the adolescents to establish a commitment to participate and start in standard DBT-A, and delivers the treatment. The only difference from the original manual is that phone consultation is offered to 8 pm. instead of 24/7. The DBT-A team offers treatment in groups, with up to six patients, to 48 patients per year. In December 2025, the recruitment for an open pre-post trial examining the outcome of standard DBT-A, predictors of outcome, and barriers to treatment run in the clinic will be finalized (REC 657876).

Rationale for an intensive DBT for adolescents. Despite standard DBT-A being effective, data from the clinics' register and the pre-post trial show that a large proportion of youths (18.3%) decline standard DBT-A even if they fulfill the inclusion criteria and have significant treatment needs. The adolescents have reported that the amount (twice weekly) and duration (20 weeks) of standard DBT-A present a challenge to them and their families to commit to treatment. Even for patients living close to the clinic, twice-weekly sessions may be impossible, as this leads to recurrent absences from school and work. Others may not need full DBT-A due to lower symptom load and functional impairment, but may still benefit from DBT-A. Fewer visits to the clinic required and digital individual sessions, may be a possible solution to these challenges. An intensive DBT-A format may also enable services to reach a larger number of youth in need. This calls for alternative approaches to delivering DBT-A.

A more intensive DBT-A has the benefit of reducing the duration of treatment while retaining the main treatment components: skills training, separate and combined youth and parent sessions, and telephone consultation as needed until 8 pm. Delivering the skills-training over consecutive days permits greater flexibility, massed practice, and facilitates the application of the skills learned, with close assistance from therapists. Also, intensive DBT can be scheduled for a convenient time, such as during a school break. Prolonged sessions and a concentrated treatment format have been successfully applied and found effective for other psychiatric disorders in youth. Furthermore, the use of a digital format for individual sessions allows for greater flexibility compared to traditional office sessions. Digital delivery can overcome potential barriers, including geographic location, time, convenience, and limited access to transport. Shortened versions of DBT for adults have been developed, with promising results. For adolescents receiving treatment in outpatient clinics, no adapted version of standard DBT-A has been developed.

The investigators has developed an intensive DBT treatment for adolescents (I-DBT), in close collaboration with lived experience advocates, clinicians, (inter)national researchers, and by using data from a systematic review and meta-analysis of adapted DBT and preliminary data from the clinics' ongoing pre-post trial (REC 657876). The I-DBT format is inspired by the innovative Bergen 4-day treatment, B4DT (https://www.helse-bergen.no/en/the-bergen-4-day-treatment-b4dt). It consists of week 1: 3 consecutive full days with therapist-assisted prolonged DBT-A skills-training group sessions with separate and joint youth and parent sessions, week 2-3: digital sessions twice weekly for the participants and once weekly for the caregiver, telephone consultations as needed until 8 pm, and week 4: a half day group session where the participants and caregiver are taught strategies for maintaining change and further self-administer DBT skills.

Project utility for patient treatment Delivering effective treatment for adolescents with self-harm and suicidal behavior, and helping their parents/caregiver to support their adolescents efficiently, has the potential for lifelong improvement. Even a small reduction in self-harm will potentially improve quality of life and daily functioning and reduce emergency hospital admissions and disabilities resulting from associated injuries, thus having a substantial economic impact. The patients and their families have called for an shortened DBT-A; and I-DBT fills this need. However, the effectiveness of I-DBT needs to be documented before implementing it broadly. Given effectiveness, I-DBT could reach a larger number of youths in need given its less resource-demanding format. The investigators propose the following gains from the current project. Short-term: reduced self-harm, suicidal behavior, BPD symptoms, and emergency hospital admissions; reduced depressive symptoms and emotional dysregulation; improved quality of life. Long-term: Mitigation of long-term adverse effects and disability for adolescents.

Research Questions and Objectives The study aims to evaluate the feasibility of Intensive DBT (I-DBT) for adolescents aged 14-18 years presenting with self-harm and suicidal behavior. I-DBT is delivered over a 4-week period. Primary outcomes include feasibility metrics such as recruitment, acceptability, and dropout rates, as well as preliminary effects on reductions in self-harm and suicidal behavior. Secondary outcomes include acute hospital admissions, depressive symptoms, quality of life, treatment acceptability, and dropout.

Procedure A therapist at the Child and Adolescent Mental Health Service (BUP) contacts the DBT-A team coordinator if assessment indicates self-harm or suicidal ideation. Patients are referred to the DBT-A team for further evaluation if the coordinator considers the patient to meet inclusion criteria for standard DBT-A. Up to four sessions are used for assessment, motivational work, and establishing treatment commitment. Assessment includes the SCID-5-PD (29) to evaluate BPD traits. Adolescents who qualify are offered standard DBT-A. For feasibility testing of I-DBT, the program will be offered to adolescents who meet criteria for standard DBT-A but decline due to treatment length and/or travel challenges. They will receive information about the I-DBT project and may be contacted by a project coordinator who provides further information and, if relevant, obtains informed consent. Consent from both guardians is required for participation. Families will be informed that declining I-DBT still entitles them to standard clinical care at BUP.

After providing informed consent, participants complete the primary and secondary outcome measures. Groups will commence once 4-6 adolescents are recruited.

Data Storage Data will be stored in a research registry at Haukeland University Hospital, approved by the Norwegian Data Protection Authority, and will be handeled according to the regulations.

User Involvement To ensure that the intervention is feasible and appropriate for the adolescents it is designed for, two adolescents with lived experience of self-harm and their parents have been involved in developing I-DBT. The initiative to develop I-DBT also originated from patients. User involvement is integrated throughout the project.

Ethics Approval from the Regional Committees for Medical and Health Research Ethics (REK) is secured. Offering a shortened version of DBT-A without robust clinical evidence raises important ethical considerations. Weekly diary cards will be collected, and any signs of deterioration or increased risk will be addressed immediately as part of the therapeutic process. Close collaboration with parents/caregivers will be maintained throughout the treatment. If other forms of deterioration or increased risk are observed, established clinical procedures at the clinic will be followed.

Participants are free to withdraw from the study at any time without losing their right to other clinical services. In the event of dropout, group leaders will ensure that the participant is connected to their local Child and Adolescent Mental Health Service (BUP). Confidentiality will be agreed upon among all group members, including both parents and adolescents, as part of the treatment protocol. For post-treatment assessments, a plan will be prepared to manage any potential negative reactions experienced by participants.

Being tested
Intensive Dialectical Behavior Therapy
Keywords
deliberate self harm, suicidal behanvor,, adolescents, DBT, Intensive treatment, Borderline Personality Disorder
Medical subject headings
Self-Injurious Behavior, Borderline Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Dialectical Behavior TherapyBehavioural

    4 weeks intensive DBT that include the same main DBT components: a multifamily skills training group (with a group size of 4-6 youth and their caregiver) and individual sessions. It has a inclusion of digital sessions in I-DBT.

Study groups in NCT07450105
Study groupRoleWhat they receive
Single group intervention-Intensive DBT (I-DBT)OtherSingle group intervention
Receives: Behavioral: Intensive Dialectical Behavior Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Assessment of Self-Mutilation

    The number of self-harm episodes and suicide attempts will be assessed before and after treatment and at 3 months follow-up. Outcome data will be collected using the Functional Assessment of Self-Mutilation (30). The adolescent interview evaluates presence, frequency, severity, suicidal intent, and medical treatment following self-inflicted injury.

    Measured: pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)

Secondary outcomes (3)
  1. Short Mood and Feelings Questionnaire

    Depressive symptoms will be assessed using the Short Mood and Feelings Questionnaire (SMFQ, 13-item) (34).

    Measured: pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)

  2. Kidscreen

    Quality of life will be measured with KIDSCREEN (10-item), adolescent and parent versions (35). Secondary outcomes will be collected pre- and post-treatment, and 3 months follow-up

    Measured: pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)

  3. Acute hospital admissions related to suicidal behavior

    Acute hospital admissions related to suicidal behavior will be retrieved from the patient's medical record.

    Measured: pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2026
  2. Study start2 Mar 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07450105
Sponsor's protocol ID
946517
Status last verified
Apr 2026
First submitted
2 Feb 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Feasibility study

Publications

  • Kazdin AE, Holland L, Crowley M, Breton S. Barriers to Treatment Participation Scale: evaluation and validation in the context of child outpatient treatment. J Child Psychol Psychiatry. 1997 Nov;38(8):1051-62. doi: 10.1111/j.1469-7610.1997.tb01621.x.

    PubMed 9413802
  • Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

    PubMed 11132119
  • Bohus M, Kleindienst N, Limberger MF, Stieglitz RD, Domsalla M, Chapman AL, Steil R, Philipsen A, Wolf M. The short version of the Borderline Symptom List (BSL-23): development and initial data on psychometric properties. Psychopathology. 2009;42(1):32-9. doi: 10.1159/000173701. Epub 2008 Nov 20.

    PubMed 19023232
  • Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.

    PubMed 2002127
  • Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med. 2006 Jul 4;145(1):62-9. doi: 10.7326/0003-4819-145-1-200607040-00011.

    PubMed 16818930
  • Ost LG, Ollendick TH. Brief, intensive and concentrated cognitive behavioral treatments for anxiety disorders in children: A systematic review and meta-analysis. Behav Res Ther. 2017 Oct;97:134-145. doi: 10.1016/j.brat.2017.07.008. Epub 2017 Jul 17.

    PubMed 28772195
  • Syversen AM, Schonning V, Fjellheim GS, Elgen I, Wergeland GJ. Evaluation of dialectical behavior therapy for adolescents in routine clinical practice: a pre-post study. BMC Psychiatry. 2024 Jun 14;24(1):447. doi: 10.1186/s12888-024-05876-z.

    PubMed 38877441
  • Glenn CR, Esposito EC, Porter AC, Robinson DJ. Evidence Base Update of Psychosocial Treatments for Self-Injurious Thoughts and Behaviors in Youth. J Clin Child Adolesc Psychol. 2019 May-Jun;48(3):357-392. doi: 10.1080/15374416.2019.1591281. Epub 2019 May 2.

    PubMed 31046461
  • Chen X, Dong Y, Ye M, Wang X, Yan J, Yao Y, Qi Z, Qian C, Liu Z. Comparative efficacy and acceptability of psychotherapeutic, pharmacological, and combination treatments for non-suicidal self-injury in children and adolescents: a systematic review and network meta-analysis. BMC Psychiatry. 2025 Apr 3;25(1):328. doi: 10.1186/s12888-025-06735-1.

    PubMed 40181383
  • Rathus JH, Miller AL. Dialectical behavior therapy adapted for suicidal adolescents. Suicide Life Threat Behav. 2002 Summer;32(2):146-57. doi: 10.1521/suli.32.2.146.24399.

    PubMed 12079031
  • Linehan MM, Heard HL, Armstrong HE. Naturalistic follow-up of a behavioral treatment for chronically parasuicidal borderline patients. Arch Gen Psychiatry. 1993 Dec;50(12):971-4. doi: 10.1001/archpsyc.1993.01820240055007.

    PubMed 8250683
  • Peterson C, Haileyesus T, Stone DM. Economic Cost of U.S. Suicide and Nonfatal Self-harm. Am J Prev Med. 2024 Jul;67(1):129-133. doi: 10.1016/j.amepre.2024.03.002. Epub 2024 Mar 12.

    PubMed 38479565
  • Doering S. Borderline Personality Disorder in Patients With Medical Illness: A Review of Assessment, Prevalence, and Treatment Options. Psychosom Med. 2019 Sep;81(7):584-594. doi: 10.1097/PSY.0000000000000724.

    PubMed 31232916
  • Witt K, Milner A, Spittal MJ, Hetrick S, Robinson J, Pirkis J, Carter G. Population attributable risk of factors associated with the repetition of self-harm behaviour in young people presenting to clinical services: a systematic review and meta-analysis. Eur Child Adolesc Psychiatry. 2019 Jan;28(1):5-18. doi: 10.1007/s00787-018-1111-6. Epub 2018 Feb 3.

    PubMed 29397445
  • Kothgassner OD, Goreis A, Robinson K, Huscsava MM, Schmahl C, Plener PL. Efficacy of dialectical behavior therapy for adolescent self-harm and suicidal ideation: a systematic review and meta-analysis. Psychol Med. 2021 May;51(7):1057-1067. doi: 10.1017/S0033291721001355. Epub 2021 Apr 20.

    PubMed 33875025

Questions about this trial

What is this clinical trial studying?

A study testing Intensive Dialectical Behavior Therapy in people with Self-Harm, Deliberate and Suicidal Behavior, run by Haukeland University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Assessment of Self-Mutilation (time frame: pre treatment (baseline), post treatment at 4 weeks following baseline, 12 weeks post treatment (3 months follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07450105, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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