Self-harmNCT06315075
Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial
A study testing Dialectical behavior therapy for adolescents (DBT-A) in people with Self-harm and Suicidal Ideation, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Self-harm, Suicidal Ideation, Suicide and Self-harm
- What is being tested?
- Dialectical behavior therapy for adolescents (DBT-A)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jan 2024to 31 Dec 2029
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13-18 years
- Ongoing or a history of self-harm the last six months; current suicidal behavior (suicidal thoughts or at least one suicide attempt within the previous six months); at least three criteria of Diagnostic and Statistical Manual -5 (DSM-5) Borderline personality disorder (BPD), or the self-destruction criterion of DSM-5 BPD in addition to minimum two subthreshold criteria as assessed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (First et al., 2016)
- Fluency in Norwegian
- One parent/trusted adult that can participate together with the adolescent.
Who cannot join
- Intellectual disability
- Significant learning or language impairments
- Autism spectrum disorder
- Anorexia Nervosa
- Any psychotic disorder
- Substance abuse disorder. These patients will be offered treatment as usual at their local outpatient clinic.
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, 1 recruiting
- Recruiting
Dept. of child and adolescent psychiatry, Haukeland University Hospital
Bergen, Bergen, 5021
Gro Janne H. Wergeland, MD, PhD, +47 48176828, gneh@helse-bergen.no
Anne Mari Syversen, Psychol, +4755975000, anne.mari.syversen@helse-bergen.no
About this study
Official title: Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open
The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are:
- to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A.
- to investigate how well DBT-A works at 12 months follow-up
- to investigate whether pre-treatment factors can predict who will benefit from treatment
Read the detailed description
Self-harm and suicidal ideation are prevalent among adolescents and associated with major mental health problems and adverse life events. Dialectical behavior therapy for adolescents (DBT-A) is an empirically supported treatment for self-harm and suicidal ideation in adolescents. However, knowledge is scarce on the effectiveness, long-term outcomes, acceptability, and dropout of DBT-A when implemented and delivered as part of routine clinical practice in the Norwegian national health care system. The main aim of this study is to examine the outcomes from DBT-A in terms of self-harm episodes, suicide attempts, and emergency hospital admission, in addition to acceptability and dropout, when DBT-A is delivered at the Department of Child and adolescent psychiatry (PBU), Haukeland University Hospital (HUS). The study is an uncontrolled pre-post study with one-year follow-up and includes three aims: to evaluate outcomes of DBT-A up to three months post-treatment, at one-year follow-up, and to describe predictors of outcome for adolescents receiving DBT-A.
- Conditions
- Self-harm, Suicidal Ideation, Suicide and Self-harm
- Being tested
- Dialectical behavior therapy for adolescents (DBT-A)
- Keywords
- Suicide and Self-harm, Adolescents, Dialectical behavior therapy for adolescents, Routine clinical practice, Effectiveness study
- Medical subject headings
- Self-Injurious Behavior, Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavior therapy for adolescents (DBT-A)Behavioural
Also called DBT-A
A 20-week DBT-A with a weekly individual session (45 minutes), a weekly session of multifamily skills training groups with a caregiver (120 minutes), and telephone consultation with individual therapists outside therapy sessions as needed. The treatment consists of four components and is delivered according to the manual except for the phone coaching that PBU offers workdays until 8 pm.
| Study group | Role | What they receive |
|---|---|---|
| DBT-A | Experimental | Single group uncontrolled study. All participants will receive DBT-A Receives: Behavioral: Dialectical behavior therapy for adolescents (DBT-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Self-Mutilation (FASM)
Number of self-harm episodes in the last four weeks categorized by intention and self-harm method, number of suicide attempts, and number of emergency department visits caused by suicidal behavior. In addition, FASM includes functional assessment of self-mutilation.
Measured: pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up
Number of participants in need of emergency department visits caused by suicidal behavior
Medical record data extraction
Measured: pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up
Secondary outcomes (4)
Depressive symptom score measured by Short Mood and Feelings questionnaire (SMFQ)
Depressive symptoms. SMFQ includes 13 items, measured on a 0-2 Likert scale, with higher scores indicating a higher level of depressive symptoms.
Measured: pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up
Health related quality of life measured by SCREENing for and Promotion of Health Related Quality of Life in Children an Adolescents (Kidscreen 10)
Kidscreen includes 10 items measured on a 5 point Likert scale and gives a global measure from 0-100 of health-related quality of life in addition to the individual aspects. Higher scores reflects higher health related quality of life.
Measured: pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up
Barriers to Treatment Participation Scale (BTPS) score
The BTPS questionnaire evaluate reasons for treatment discontinuation, and treatment participation barriers.
Measured: pre, at dropout at any time between session 1 and end of treatment at session 20.
Perceived benefit of skills training in DBT-A measured by a study specific questionnaire.
Perceived benefit of skills training in DBT-A is a study-specific patient- and parent reported evaluation measure of perceived benefits of DBT-A components rated on a 0-5 Likert scale.
Measured: At dropout at any time between session 1 and end of treatment at session 20, or for completers after 20 weeks DBT-A ("post"),
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start15 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-harmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Single group, uncontrolled, pre-post-one year follow-up study
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gro Janne H. Wergeland, MD, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315075
- Sponsor's protocol ID
- 657876
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open
- ClinicalTrials.gov ID
- NCT06315075
- Acronym / sponsor ID
- 657876
- Conditions
- Self-harm, Suicidal Ideation, Suicide and Self-harm
- Keywords
- Suicide and Self-harm, Adolescents, Dialectical behavior therapy for adolescents, Routine clinical practice, Effectiveness study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are:
- to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A.
- to investigate how well DBT-A works at 12 months follow-up
- to investigate whether pre-treatment factors can predict who will benefit from treatment
Detailed description
Self-harm and suicidal ideation are prevalent among adolescents and associated with major mental health problems and adverse life events. Dialectical behavior therapy for adolescents (DBT-A) is an empirically supported treatment for self-harm and suicidal ideation in adolescents. However, knowledge is scarce on the effectiveness, long-term outcomes, acceptability, and dropout of DBT-A when implemented and delivered as part of routine clinical practice in the Norwegian national health care system. The main aim of this study is to examine the outcomes from DBT-A in terms of self-harm episodes, suicide attempts, and emergency hospital admission, in addition to acceptability and dropout, when DBT-A is delivered at the Department of Child and adolescent psychiatry (PBU), Haukeland University Hospital (HUS). The study is an uncontrolled pre-post study with one-year follow-up and includes three aims: to evaluate outcomes of DBT-A up to three months post-treatment, at one-year follow-up, and to describe predictors of outcome for adolescents receiving DBT-A.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, uncontrolled, pre-post-one year follow-up study
| Arm | Type | Receives |
|---|---|---|
| DBT-A | Experimental | Behavioral: Dialectical behavior therapy for adolescents (DBT-A)Single group uncontrolled study. All participants will receive DBT-A |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 13-18 years
- Ongoing or a history of self-harm the last six months; current suicidal behavior (suicidal thoughts or at least one suicide attempt within the previous six months); at least three criteria of Diagnostic and Statistical Manual -5 (DSM-5) Borderline personality disorder (BPD), or the self-destruction criterion of DSM-5 BPD in addition to minimum two subthreshold criteria as assessed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (First et al., 2016)
- Fluency in Norwegian
- One parent/trusted adult that can participate together with the adolescent.
Key exclusion criteria (6 listed)
- Intellectual disability
- Significant learning or language impairments
- Autism spectrum disorder
- Anorexia Nervosa
- Any psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical behavior therapy for adolescents (DBT-A)Also: DBT-AA 20-week DBT-A with a weekly individual session (45 minutes), a weekly session of multifamily skills training groups with a caregiver (120 minutes), and telephone consultation with individual therapists outside therapy sessions as needed. The treatment consists of four components and is delivered according to the manual except for the phone coaching that PBU offers workdays until 8 pm. | Behavioural | DBT-A |
Primary outcome
Functional Assessment of Self-Mutilation (FASM)
Time frame: pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up
Number of self-harm episodes in the last four weeks categorized by intention and self-harm method, number of suicide attempts, and number of emergency department visits caused by suicidal behavior. In addition, FASM includes functional assessment of self-mutilation.
Number of participants in need of emergency department visits caused by suicidal behavior
Time frame: pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up
Medical record data extraction
4 secondary outcomes
Depressive symptom score measured by Short Mood and Feelings questionnaire (SMFQ)
Time frame: pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up
Health related quality of life measured by SCREENing for and Promotion of Health Related Quality of Life in Children an Adolescents (Kidscreen 10)
Time frame: pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up
Barriers to Treatment Participation Scale (BTPS) score
Time frame: pre, at dropout at any time between session 1 and end of treatment at session 20.
Perceived benefit of skills training in DBT-A measured by a study specific questionnaire.
Time frame: At dropout at any time between session 1 and end of treatment at session 20, or for completers after 20 weeks DBT-A ("post"),
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gro Janne H. Wergeland, MD, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavior therapy for adolescents (DBT-A) in people with Self-harm and Suicidal Ideation, 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 4 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: looking for participants now, as of the sponsor's last update on 31 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?
Contact Gro Janne H. Wergeland, MD, PhD (+47 48176828, gneh@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Self-Mutilation (FASM) (time frame: pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.