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Clinical Trials/NCT04318899
NCT04318899
Recruiting
Not Applicable

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

Oslo University Hospital5 sites in 1 country250 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Self Harm
Sponsor
Oslo University Hospital
Enrollment
250
Locations
5
Primary Endpoint
Suicidal Ideation (adults)
Status
Recruiting
Last Updated
last year

Overview

Brief 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 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.

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: 1. 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? 2. 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. 3. What are significant moderators of treatment response with respect to key clinical outcomes (mentioned above)? 4. 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lars Mehlum

Professor dr med

Oslo University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Suicidal Ideation (adults)

Time Frame: 4 weeks

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

Depressive symptoms (adolescents)

Time Frame: 1 week

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

Self-harm behaviour

Time Frame: 4 weeks

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

Suicidal Ideation (adolescents)

Time Frame: 2 weeks

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

Depressive symptoms

Time Frame: 1 week

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

Depressive symptoms (adults)

Time Frame: 1 week

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

Secondary Outcomes

  • Borderline Symptoms(1 week)
  • Hopelessness(1 week)

Study Sites (5)

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