Self HarmNCT04318899
Predictors of Clinical Course and Treatment Response in DBT Programmes
A study testing Dialectical Behaviour Therapy adapted for adolescents (DBT-A) and Dialectical Behaviour Therapy - Standard version (DBT) in people with Self Harm and Borderline Personality Disorder, run by Oslo University Hospital at 5 sites in Norway.
Trial summary
The project is a collaboration between The National Centre for Suicide Research and Prevention (NSSF) and clinical units with Dialectical Behaviour Therapy (DBT) programmes. A methodological and technological platform has been established that enables clinicians to deliver high quality treatments over extended periods… Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Self Harm, Borderline Personality Disorder
- What is being tested?
- Dialectical Behaviour Therapy adapted for adolescents (DBT-A) and Dialectical Behaviour Therapy - Standard version (DBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 5 sitesNorway
- Study dates
- 1 Jan 2018to 31 Dec 2029
- Phase
- Interventional
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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of repeated deliberate self harm
- Satisfies criteria of Diagnostic and Statistical Manual (DSM-IV) Borderline Personality Disorder as measured by Structured Clinical Interview for the DSM (SCID-II) in addition to the self-destructive criterion.
Who cannot join
- Psychotic disorders
- Anorexia Nervosa
- Substance dependence disorder
- Mental retardation (IQ less than 70)
- Asperger syndrome/autism
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Norway5 sites, 5 recruiting
- Recruiting
Moss DPS/Østfold sykehus HF
Moss, 1535
Eva Utne Haldorsen Kalla, MD, eva.utne.haldorsen.kalla@so-hf.no
- Recruiting
Søndre Oslo DPS/Oslo Universitetssykehus HF
Oslo, Oslo, 1281
Tone Enge Berthelsen, MA, UXBETG@ous-hf.no
- Recruiting
Psykiatrisk senter ytre Helgeland/Helgelandssykehuset HF
Sandnessjøen, 8800
Gry E Konradsen, Psych Nurse, Gry.Elin.Konradsen@Helgelandssykehuset.no
- Recruiting
Bjerketun behandlingshjem/Vestreviken HF
Sandvika, 1341
Kristoffer Ødegård, MA, oedkri@vestreviken.no
- Recruiting
BUP Lian/St Olavs Hospital HF
Trondheim, 7024
Marthe Stornes, MA, marthe.stornes@stolav.no
About this study
Official title: Predictors of Clinical Course and Treatment Response in Patients Having Received Dialectical Behaviour Therapy Delivered by Clinical Units in the Norwegian Network for Clinical Evaluation and Quality in DBT Programmes
The project is a collaboration between The National Centre for Suicide Research and Prevention (NSSF) and clinical units with Dialectical Behaviour Therapy (DBT) programmes. A methodological and technological platform has been established that enables clinicians to deliver high quality treatments over extended periods of time, to evaluate their own performance and productivity and to report it in a uniform and systematic way that will enable comparison across clinical settings and programmes. The collected data constitute the basis for conducting the clinical study with the overall aim to study predictors of the clinical course and treatment response in patients admitted to DBT programmes in Norway.
Read the detailed description
The aim of the project is to collect data from systematic and uniform clinical assessments to study predictors of the clinical course and treatment response in patients admitted to and treated in clinical units delivering Dialectical Behaviour Therapy in Norway.
Aims and research questions:
The study will address the following main research questions:
- Which patient characteristics (sociodemographic variables, psychiatric diagnoses/comorbidities, previous suicidal and self-harming behaviour, previous treatment history), predict a favourable clinical course and treatment response?
- Which factors mediate the clinical change in key outcomes such as a) target symptom levels (depression, hopelessness, suicidal ideation, borderline symptoms etc.), b) function levels (emotion regulation capacity, use of coping skills, social functioning, occupational / academic performance level etc.), c) problem behaviours (suicide attempts, non-suicidal self-harm, substance abuse, eating disorder symptoms etc.), d) global functioning and e) the use of emergency treatment services.
- What are significant moderators of treatment response with respect to key clinical outcomes (mentioned above)?
- Which of the treatment modalities are evaluated as the most salient and helpful by patients who receive the treatment according to their age, gender, psychiatric diagnoses and previous treatment history?
Methods:
A uniform protocol for psychiatric diagnostics and clinical assessment of patients who receive treatment at the participating clinical units will be used. Since some participating clinical units will treat adult patients and some will treat children and adolescents, the protocol will offer assessment instrument suitable for the specific age group whenever this is relevant. The evaluation system includes assessments at baseline before treatment starts, evaluation at several time points during the treatment period, at termination of treatment and at follow-up. Assessments will be made both through interviews and ratings made by therapists and through self-report from patients.
Self-reports will be filled out electronically by patients, on tablets stationed at each participating clinical unit. At intervals patients will also provide self-rated information on dimensions such as emotions, cognitions and impulsive behaviour several times per day through a mobile app developed specifically for the purpose, so-called Ecological Momentary Assessment (EMA). Interview data and ratings will be entered into the database by each clinician to tablets in a similar fashion as self-report data from patients.
- Conditions
- Self Harm, Borderline Personality Disorder
- Being tested
- Dialectical Behaviour Therapy adapted for adolescents (DBT-A), Dialectical Behaviour Therapy - Standard version (DBT)
- 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 adapted for adolescents (DBT-A)Behavioural
DBT developed by Marsha Linehan (Linehan 1993a; 1993b) and adapted for adolescents (DBT-A) by Miller, Rathus \& Linehan, 2007 consisting of 20 weeks of weekly individual therapy (60 minutes), multifamily skills training (120 minutes), family therapy sessions as needed and telephone coaching outside therapy sessions.
Dialectical Behaviour Therapy - Standard version (DBT)Behavioural
DBT developed by Marsha Linehan (Linehan 1993a, 1993 b) consisting of 1 weekly session of individual therapy (60 minutes), 1 weekly session of skills training (120 minutes), and telephone coaching with individual therapists outside therapy sessions as needed.
| Study group | Role | What they receive |
|---|---|---|
| Dialectical Behaviour Therapy | Experimental | Dialectical Behavior Therapy, delivered for 20 weeks for adolescents (DBT-A) or 52 weeks for adults (standard DBT. Receives: Behavioral: Dialectical Behaviour Therapy adapted for adolescents (DBT-A); Behavioral: Dialectical Behaviour Therapy - Standard version (DBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-harm behaviour
Number of self-harm episodes (split on suicide attempts and non-suicidal self-harm)
Measured: 4 weeks
Suicidal Ideation (adolescents)
Suicidal Ideation Questionnaire (SIQ-Jr). Min=0, Max=90. Higher scores indicate worse outcome
Measured: 2 weeks
Depressive symptoms
MADRS (Montgomery Asberg Depression Rating Scale).Min=0, Max=60. Higher scores indicate worse outcome
Measured: 1 week
Suicidal Ideation (adults)
Beck Scale for Suicidal Ideation (BSS). MIn=0, Max=38. Higher scores indicate worse outcome
Measured: 4 weeks
Depressive symptoms (adolescents)
Moods and Feelings Questionnaire (MFQ). Min=0, Max=26. Higher scores indicate worse outcome
Measured: 1 week
Depressive symptoms (adults)
Beck Depression Inventory (BDI). Min=0, Max=63. Higher scores indicate worse outcome
Measured: 1 week
Secondary outcomes (2)
Borderline Symptoms
Borderline Symptom List (BSL-23). Min=0, Max=92. Higher scores indicate more symptoms.
Measured: 1 week
Hopelessness
Beck Hopelessness Scale (BHS). Min=0, Max=20. Higher scores indicate more hopelessness.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Self HarmStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vestre Viken Hospital Trust, St. Olavs Hospital, Sykehuset Ostfold, University of Oslo, Nordlandssykehuset HF
- 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
- NCT04318899
- Sponsor's protocol ID
- 2017/1247/REK sør-øst
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2020
- Last updated
- 16 Oct 2026
- 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