Clinical trial NCT04318899: Predictors of Clinical Course and Treatment Response in DBT Programmes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Self Harm
Borderline Personality Disorder
Keywords: self harm
dialectical behaviour therapy
borderline personality disorder
emotional dysregulation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Vestre Viken Hospital Trust
name: St. Olavs Hospital
name: Sykehuset Ostfold
name: University of Oslo
name: Nordlandssykehuset HF
First posted: 2020-03-24
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self-harm behaviour
timeFrame: 4 weeks
measure: Suicidal Ideation (adolescents)
timeFrame: 2 weeks
measure: Depressive symptoms
timeFrame: 1 week
measure: Suicidal Ideation (adults)
timeFrame: 4 weeks
measure: Depressive symptoms (adolescents)
timeFrame: 1 week
measure: Depressive symptoms (adults)
timeFrame: 1 week
Secondary outcomes:
measure: Borderline Symptoms
timeFrame: 1 week
measure: Hopelessness
timeFrame: 1 week
Other outcomes:
Locations:
city: Moss
country: Norway
facility: Moss DPS/Østfold sykehus HF
city: Oslo
country: Norway
facility: Søndre Oslo DPS/Oslo Universitetssykehus HF
city: Sandnessjøen
country: Norway
facility: Psykiatrisk senter ytre Helgeland/Helgelandssykehuset HF
city: Sandvika
country: Norway
facility: Bjerketun behandlingshjem/Vestreviken HF
city: Trondheim
country: Norway
facility: BUP Lian/St Olavs Hospital HF
Study officials:
affiliation: University of Oslo
name: Lars Mehlum, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Linehan, M.M. (1993a). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press
citation: Linehan, M.M. (1993b). Skills training manual for treating borderline personality disorder. New York: Guilford Press
citation: Miller, A.L., Rathus J.H., Linehan, M.M. (2007). Dialectical behavioral therapy with suicidal adolescents. New York: Guilford Press