Self-Harm, DeliberateNCT04298190
Dialectical Behavior Therapy vs Enhanced Usual Care for Suicidal and Self-harming Adolescents. 10 Year Follow-up
A study testing Dialectical Behaviour Therapy for Adolescents (DBT-A) in people with Self-Harm, Deliberate and Borderline Personality Disorder, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of the study is to evaluate the long-term efficacy of dialectical behavior therapy (DBT) in treatment of adolescents with deliberate self harm compared to enhanced usual care (EUC). This study follows-up 77 patients in the ages of 12-18 yrs who have been included in an RCT of DBT-A vs EUC. Read more about this study
- Who is it for?
- Ages 22 to 30 years
- Conditions the study is for
- Self-Harm, Deliberate, Borderline Personality Disorder
- What is being tested?
- Dialectical Behaviour 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
- 61 participants
- Where
- 1 siteNorway
- Study dates
- 15 May 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Psychotic disorders or
- Anorexia nervosa or
- Severe substance dependence disorders or
- Mental retardation (IQ less than 70) or
- Asperger syndrome/autism -
Trial locations and contacts
1 site in 1 country.
Norway1 site
National Centre for Suicide Research and Prevention Unit/University of Oslo
Oslo, 0372
About this study
Official title: Dialectical Behavior Therapy vs Enhanced Usual Care for Suicidal and Self-harming Adolescents. Outcomes in Adult Life 10 Years Posttreatment
The purpose of the study is to evaluate the long-term efficacy of dialectical behavior therapy (DBT) in treatment of adolescents with deliberate self harm compared to enhanced usual care (EUC). This study follows-up 77 patients in the ages of 12-18 yrs who have been included in an RCT of DBT-A vs EUC. The main inclusion criterion for this study was repetitive self-harm behaviour. The patients were randomly allocated to receive 16 weeks of outpatient DBT or EUC in child and adolescent psychiatric clinics in Oslo. Participants have been assessed so far on six different time-points: baseline (before starting treatment), 9 weeks, 15 weeks, 19 weeks, 71 weeks and 3 years after start of the treatment. In the current project patients will be assessed a 7th time 10 years after treatment completion.
It is hypothesized that compared with participants who had received EUC in the original trial during their adolescence participants who had received DBT-A will:
- report a significantly lower frequency of episodes of self-harm, both last year and over the extended 10-year follow-up interval.
- be significantly less impaired with respect to social, family and occupational functioning and report a higher quality of life.
- have retained significantly fewer diagnostic criteria of BPD and have less severe borderline features according to dimensional measures and have significantly fewer signs of emotion dysregulation.
Read the detailed description
Suicide attempts and non-suicidal self-harm, highly prevalent in adolescents, are behaviours strongly associated with severe emotion dysregulation, mental health problems and increased suicide risk. The original study, on which the present study is building, used a randomized controlled design, with a stratified block randomization procedure, and blinded pre-treatment, post-treatment and follow-up evaluations comparing 19weeks of DBT-A with EUC of equal length.
Of special interest to this follow-up study is to gain more knowledge on their capacity to regulate emotions, since failures in emotion regulation is an underlying mechanism of repetitive self-harm behaviours and several other difficulties, and since a main aim of DBT-A is to enhance adolescents capacity to use healthy emotion regulation strategies. The study is designed to carefully include user and family perspectives on the definition of specific outcomes and how to measure them, we will collect detailed data on important outcomes employing a combination of quantitative and qualitative methods, innovative approaches such as ecological momentary assessment and register data. Adding new data to the existing rich data will give us a basis to study the dynamic interplay between symptoms, emotions, and functional and dysfunctional behaviours and make new discoveries of mechanisms of therapeutic change, knowledge to further increase treatment response rates and individualize treatments and to inform further development of this treatment and its implementation in Norway and other countries.
The proposed study will investigate:
- the 10-year post-randomization treatment outcomes of DBT-A compared with EUC with respect to: a) frequency of subsequent episodes of self-harm, b) severity of suicidal ideation, c) level of depressive symptoms and d) frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of self-harm behaviour.
- the 10-year post-randomization clinical course and stability of a diagnosis of BPD, its diagnostic criteria and borderline symptoms.
- participants' adult mental health, social, family and occupational functioning and quality of life.
- participants' adult strategies for and capacity to cope with stressful life-events and situations in their daily lives and effectively regulate emotions.
- the association between participants' adult life use of skills and functional coping strategies and self-harm behaviour and other problem behaviours, and whether any substitution from onedysfunctional coping behaviour to another has occurred.
- participants' evaluation of what components of the treatment was most helpful and led to the strongest and most persistent change in important functions and aspects of life.
- the economic cost of treatments consumed and functional impairment and occupational disability over the 10-year post-randomization period and the long-term cost-effectiveness of DBT-A.
- Being tested
- Dialectical Behaviour Therapy for Adolescents (DBT-A), Enhanced usual care
- Keywords
- self harm, dialectical behaviour therapy, borderline personality disorder, emotional dysregulation
- 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.
Dialectical Behaviour Therapy for Adolescents (DBT-A)Behavioural
16 weeks of Dialectical behavior therapy with one weekly session of individual therapy, one weekly session of multifamily skills training group, telephone coaching and ancillary family therapy and/or pharmacological treatment as needed.
The treatment has been developed by Marsha Linehan (Linehan, 1993a; 1993b)and adapted for adolescents by Alec Miller (Miller, Rathus \& Linehan, 2007). Individual DBT therapists have been trained by drs Alec L Miller and Sarah K Reynolds and have a minimum of one year clinical practise as DBT therapists. The therapists are organised in two consultation teams supervised on a bimonthly basis throughout the entire study by drs Miller and Reynolds respectively.
Enhanced usual careBehavioural
16 weeks of outpatient treatment in child and adolescent psychiatric clinics in Oslo, on average one weekly session of individual therapy and ancillary supportive family and/or pharmacological treatment as needed.
| Study group | Role | What they receive |
|---|---|---|
| Dialectical Behaviour Therapy | Experimental | Dialectical Behavior Therapy, delivered for 19 weeks, consisted of 1 weekly session of individual therapy (60 minutes), 1 weekly session of multifamily skills training (120 minutes), and family therapy sessions and Telephone coaching with individual therapists outside therapy sessions as needed. Receives: Behavioral: Dialectical Behaviour Therapy for Adolescents (DBT-A) |
| Enhanced Usual Care | Active comparator | Enhanced usual care was 19 weeks of standard care (enhanced for the purpose of the study by requiring that EUC therapists agree to provide on average no less than 1 weekly treatment session per patient throughout the trial) delivered by therapists (4 psychiatrists, 16 clinical psychologists, 6 clinical social workers, 2 clinical pedagogues, 1 specialist nurse, and 1 psychology graduate student) not trained in or practicing DBT. Receives: Behavioral: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of subsequent episodes of self-harm
Measured by the Linehan Parasuicide Count (LPC)
Measured: 10 years
Secondary outcomes (4)
Severity of suicidal ideation
Measured by the Suicidal Ideation Questionnaire Jr (SIQ-Jr). Scale range: min= 0, max = 90. High values represent a worse outcome.
Measured: 10 years
Self-reported evel of depressive symptoms
Measured by the Moods and feelings questionnaire (MFQ). Scale range: min = 0, max = 26. High levels represent a worse outcome
Measured: 10 years
Researcher rated level of depressive symptoms
Measured by the Montgomery Asberg Depression Rating Scale (MADRS). Scale range: min=0, max=60. High levels represent a worse outcome
Measured: 10 years
Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of self-harm behaviour
Measured through and interview specifically developed for the purpose and through linkage with the Norwegian Patient Register
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start15 May 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Self-Harm, DeliberateStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Lars Mehlum, Oslo University Hospital
- Investigators
- Lars Mehlum, MD PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298190
- Sponsor's protocol ID
- ES641048
- Status last verified
- Oct 2023
- First submitted
- 4 Mar 2020
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Linehan, M.M. (1993a). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press
Linehan, M.M. (1993b). Skills training manual for treating borderline personality disorder. New York: Guilford Press
Miller, A.L., Rathus J.H., Linehan, M.M. (2007). Dialectical behavioral therapy with suicidal adolescents. New York: Guilford Press
Dibaj IS, Galfalvy H, Tormoen AJ, Haga E, Mehlum L. Does Dialectical Behaviour Therapy for adolescents affect suicidal ideation and use of coping skills in adulthood? A 12.4-years follow-up study of a Randomized Trial using Ecological Momentary Assessment. Behav Res Ther. 2026 Aug;203:105091. doi: 10.1016/j.brat.2026.105091. Epub 2026 Jun 9.
PubMed 42308592Mehlum L, Dibaj IS, Haga E, Helle SE, Morken KTE, Klungsoyr O, Tormoen AJ. Adult life outcomes for adolescents 12.4 years after dialectical behavior therapy - a randomized clinical trial. Eur Child Adolesc Psychiatry. 2026 Mar;35(3):983-994. doi: 10.1007/s00787-025-02856-w. Epub 2026 Jan 16.
PubMed 41543545
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavior Therapy vs Enhanced Usual Care for Suicidal and Self-harming Adolescents. Outcomes in Adult Life 10 Years Posttreatment
- ClinicalTrials.gov ID
- NCT04298190
- Acronym / sponsor ID
- ES641048
- Keywords
- self harm, dialectical behaviour therapy, borderline personality disorder, emotional dysregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 15 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 6 Mar 2020 (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 purpose of the study is to evaluate the long-term efficacy of dialectical behavior therapy (DBT) in treatment of adolescents with deliberate self harm compared to enhanced usual care (EUC). This study follows-up 77 patients in the ages of 12-18 yrs who have been included in an RCT of DBT-A vs EUC. The main inclusion criterion for this study was repetitive self-harm behaviour. The patients were randomly allocated to receive 16 weeks of outpatient DBT or EUC in child and adolescent psychiatric clinics in Oslo. Participants have been assessed so far on six different time-points: baseline (before starting treatment), 9 weeks, 15 weeks, 19 weeks, 71 weeks and 3 years after start of the treatment. In the current project patients will be assessed a 7th time 10 years after treatment completion.
It is hypothesized that compared with participants who had received EUC in the original trial during their adolescence participants who had received DBT-A will:
- report a significantly lower frequency of episodes of self-harm, both last year and over the extended 10-year follow-up interval.
- be significantly less impaired with respect to social, family and occupational functioning and report a higher quality of life.
- have retained significantly fewer diagnostic criteria of BPD and have less severe borderline features according to dimensional measures and have significantly fewer signs of emotion dysregulation.
Detailed description
Suicide attempts and non-suicidal self-harm, highly prevalent in adolescents, are behaviours strongly associated with severe emotion dysregulation, mental health problems and increased suicide risk. The original study, on which the present study is building, used a randomized controlled design, with a stratified block randomization procedure, and blinded pre-treatment, post-treatment and follow-up evaluations comparing 19weeks of DBT-A with EUC of equal length.
Of special interest to this follow-up study is to gain more knowledge on their capacity to regulate emotions, since failures in emotion regulation is an underlying mechanism of repetitive self-harm behaviours and several other difficulties, and since a main aim of DBT-A is to enhance adolescents capacity to use healthy emotion regulation strategies. The study is designed to carefully include user and family perspectives on the definition of specific outcomes and how to measure them, we will collect detailed data on important outcomes employing a combination of quantitative and qualitative methods, innovative approaches such as ecological momentary assessment and register data. Adding new data to the existing rich data will give us a basis to study the dynamic interplay between symptoms, emotions, and functional and dysfunctional behaviours and make new discoveries of mechanisms of therapeutic change, knowledge to further increase treatment response rates and individualize treatments and to inform further development of this treatment and its implementation in Norway and other countries.
The proposed study will investigate:
- the 10-year post-randomization treatment outcomes of DBT-A compared with EUC with respect to: a) frequency of subsequent episodes of self-harm, b) severity of suicidal ideation, c) level of depressive symptoms and d) frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of self-harm behaviour.
- the 10-year post-randomization clinical course and stability of a diagnosis of BPD, its diagnostic criteria and borderline symptoms.
- participants' adult mental health, social, family and occupational functioning and quality of life.
- participants' adult strategies for and capacity to cope with stressful life-events and situations in their daily lives and effectively regulate emotions.
- the association between participants' adult life use of skills and functional coping strategies and self-harm behaviour and other problem behaviours, and whether any substitution from onedysfunctional coping behaviour to another has occurred.
- participants' evaluation of what components of the treatment was most helpful and led to the strongest and most persistent change in important functions and aspects of life.
- the economic cost of treatments consumed and functional impairment and occupational disability over the 10-year post-randomization period and the long-term cost-effectiveness of DBT-A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialectical Behaviour Therapy | Experimental | Behavioral: Dialectical Behaviour Therapy for Adolescents (DBT-A)Dialectical Behavior Therapy, delivered for 19 weeks, consisted of 1 weekly session of individual therapy (60 minutes), 1 weekly session of multifamily skills training (120 minutes), and family therapy sessions and Telephone coaching with individual therapists outside therapy sessions as needed. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced usual careEnhanced usual care was 19 weeks of standard care (enhanced for the purpose of the study by requiring that EUC therapists agree to provide on average no less than 1 weekly treatment session per patient throughout the trial) delivered by therapists (4 psychiatrists, 16 clinical psychologists, 6 clinical social workers, 2 clinical pedagogues, 1 specialist nurse, and 1 psychology graduate student) not trained in or practicing DBT. |
Who may qualify
- Ages
- 22 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Psychotic disorders or
- Anorexia nervosa or
- Severe substance dependence disorders or
- Mental retardation (IQ less than 70) or
- Asperger syndrome/autism -
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 Behaviour Therapy for Adolescents (DBT-A)16 weeks of Dialectical behavior therapy with one weekly session of individual therapy, one weekly session of multifamily skills training group, telephone coaching and ancillary family therapy and/or pharmacological treatment as needed. The treatment has been developed by Marsha Linehan (Linehan, 1993a; 1993b)and adapted for adolescents by Alec Miller (Miller, Rathus \& Linehan, 2007). Individual DBT therapists have been trained by drs Alec L Miller and Sarah K Reynolds and have a minimum of one year clinical practise as DBT therapists. The therapists are organised in two consultation teams supervised on a bimonthly basis throughout the entire study by drs Miller and Reynolds respectively. | Behavioural | Dialectical Behaviour Therapy |
| Enhanced usual care16 weeks of outpatient treatment in child and adolescent psychiatric clinics in Oslo, on average one weekly session of individual therapy and ancillary supportive family and/or pharmacological treatment as needed. | Behavioural | Enhanced Usual Care |
Primary outcome
Frequency of subsequent episodes of self-harm
Time frame: 10 years
Measured by the Linehan Parasuicide Count (LPC)
4 secondary outcomes
Severity of suicidal ideation
Time frame: 10 years
Self-reported evel of depressive symptoms
Time frame: 10 years
Researcher rated level of depressive symptoms
Time frame: 10 years
Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of self-harm behaviour
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- BackgroundLinehan, M.M. (1993a). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press
- BackgroundLinehan, M.M. (1993b). Skills training manual for treating borderline personality disorder. New York: Guilford Press
- BackgroundMiller, A.L., Rathus J.H., Linehan, M.M. (2007). Dialectical behavioral therapy with suicidal adolescents. New York: Guilford Press
- Derived from this study: PubMed 42308592Dibaj IS, Galfalvy H, Tormoen AJ, Haga E, Mehlum L. Does Dialectical Behaviour Therapy for adolescents affect suicidal ideation and use of coping skills in adulthood? A 12.4-years follow-up study of a Randomized Trial using Ecological Momentary Assessment. Behav Res Ther. 2026 Aug;203:105091. doi: 10.1016/j.brat.2026.105091. Epub 2026 Jun 9.
- Derived from this study: PubMed 41543545Mehlum L, Dibaj IS, Haga E, Helle SE, Morken KTE, Klungsoyr O, Tormoen AJ. Adult life outcomes for adolescents 12.4 years after dialectical behavior therapy - a randomized clinical trial. Eur Child Adolesc Psychiatry. 2026 Mar;35(3):983-994. doi: 10.1007/s00787-025-02856-w. Epub 2026 Jan 16.
- Information about the research project in NorwegianLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Lars Mehlum, MD PhD principal investigator
University of Oslo
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 Behaviour Therapy for Adolescents (DBT-A) in people with Self-Harm, Deliberate and Borderline Personality Disorder, run by Oslo 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 0 inclusion and 5 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: finished, as of the sponsor's last update on 1 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of subsequent episodes of self-harm (time frame: 10 years). 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 NCT04298190, which also lists 5 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 1 Nov 2023.