Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-01 @ 5:48 PM
Study NCT ID:
NCT07450105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Dialectical Behavior Therapy for Self-Harm and Suicidal Behavior in Youth: A Pilot Study
Sponsor:
Haukeland University Hospital
Organization:
Study Overview
Official Title:
Intensive Dialectical Behavior Therapy for Self-Harm and Suicidal Behavior in Youth: A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: