Predictors of Clinical Course and Treatment Response in DBT Programmes

Borderline Personality Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04318899
• Other study ID #: 2017/1247/REK sør-øst
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Oslo University Hospital
• Contact: Egil Haga, PhD
• Phone: +4722923442
• Email: egil.haga[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders
• Self Harm
• Self-Injurious Behavior

Intervention

Behavioral:
• Dialectical Behaviour Therapy adapted for adolescents (DBT-A)
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)
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.

Locations

Country	Name	City	State
Norway	Moss DPS/Østfold sykehus HF	Moss
Norway	Søndre Oslo DPS/Oslo Universitetssykehus HF	Oslo
Norway	Psykiatrisk senter ytre Helgeland/Helgelandssykehuset HF	Sandnessjøen
Norway	Bjerketun behandlingshjem/Vestreviken HF	Sandvika
Norway	BUP Lian/St Olavs Hospital HF	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
Oslo University Hospital	Nordlandssykehuset HF, St. Olavs Hospital, Sykehuset Ostfold, University of Oslo, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-harm behaviour	Number of self-harm episodes (split on suicide attempts and non-suicidal self-harm)	4 weeks
Primary	Suicidal Ideation (adolescents)	Suicidal Ideation Questionnaire (SIQ-Jr). Min=0, Max=90. Higher scores indicate worse outcome	2 weeks
Primary	Depressive symptoms	MADRS (Montgomery Asberg Depression Rating Scale).Min=0, Max=60. Higher scores indicate worse outcome	1 week
Primary	Suicidal Ideation (adults)	Beck Scale for Suicidal Ideation (BSS). MIn=0, Max=38. Higher scores indicate worse outcome	4 weeks
Primary	Depressive symptoms (adolescents)	Moods and Feelings Questionnaire (MFQ). Min=0, Max=26. Higher scores indicate worse outcome	1 week
Primary	Depressive symptoms (adults)	Beck Depression Inventory (BDI). Min=0, Max=63. Higher scores indicate worse outcome	1 week
Secondary	Borderline Symptoms	Borderline Symptom List (BSL-23). Min=0, Max=92. Higher scores indicate more symptoms.	1 week
Secondary	Hopelessness	Beck Hopelessness Scale (BHS). Min=0, Max=20. Higher scores indicate more hopelessness.	1 week