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NCT Number: NCT04318899

Predictors of Clinical Course and Treatment Response 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.

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Key information

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Søndre Oslo DPS/Oslo Universitetssykehus HF, Oslo, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Psychotic disorders
  • Anorexia Nervosa
  • Substance dependence disorder
  • Mental retardation (IQ less than 70)
  • Asperger syndrome/autism

Treatment and study plan

Dialectical Behaviour Therapy adapted for adolescents (DBT-A)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Self-harm behaviour

    Time frame: 4 weeks

    Number of self-harm episodes (split on suicide attempts and non-suicidal self-harm)

  2. Suicidal Ideation (adolescents)

    Time frame: 2 weeks

    Suicidal Ideation Questionnaire (SIQ-Jr). Min=0, Max=90. Higher scores indicate worse outcome

  3. Depressive symptoms

    Time frame: 1 week

    MADRS (Montgomery Asberg Depression Rating Scale).Min=0, Max=60. Higher scores indicate worse outcome

  4. Suicidal Ideation (adults)

    Time frame: 4 weeks

    Beck Scale for Suicidal Ideation (BSS). MIn=0, Max=38. Higher scores indicate worse outcome

  5. Depressive symptoms (adolescents)

    Time frame: 1 week

    Moods and Feelings Questionnaire (MFQ). Min=0, Max=26. Higher scores indicate worse outcome

  6. Depressive symptoms (adults)

    Time frame: 1 week

    Beck Depression Inventory (BDI). Min=0, Max=63. Higher scores indicate worse outcome

Secondary outcomes

  1. Borderline Symptoms

    Time frame: 1 week

    Borderline Symptom List (BSL-23). Min=0, Max=92. Higher scores indicate more symptoms.

  2. Hopelessness

    Time frame: 1 week

    Beck Hopelessness Scale (BHS). Min=0, Max=20. Higher scores indicate more hopelessness.

Study contacts

Contact information is provided by the study sponsor or research team.

Egil Haga, PhD

CONTACT

[email protected]

+4722923442

Lars Mehlum, MD PhD

CONTACT

[email protected]

+4722923442

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Nordlandssykehuset HF
  • St. Olavs Hospital
  • Sykehuset Ostfold
  • University of Oslo
  • Vestre Viken Hospital Trust

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2020
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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