Predictors of Clinical Course and Treatment Response in DBT Programmes

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.

Study Overview

• Status: Recruiting
• Conditions: Borderline Personality Disorder; Self Harm
• Intervention / Treatment: Behavioral: Dialectical Behaviour Therapy adapted for adolescents (DBT-A); Behavioral: Dialectical Behaviour Therapy - Standard version (DBT)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Egil Haga, PhD; Phone Number: +4722923442; Email: egil.haga@medisin.uio.no
• Study Contact Backup: Name: Lars Mehlum, MD PhD; Phone Number: +4722923442; Email: lars.mehlum@medisin.uio.no

Study Locations

• Norway
  • Moss, Norway, 1535
    • Recruiting
    • Moss DPS/Østfold sykehus HF
    • Contact: Eva Utne Haldorsen Kalla, MD; Email: eva.utne.haldorsen.kalla@so-hf.no
  • Oslo, Norway, 1281
    • Recruiting
    • Søndre Oslo DPS/Oslo Universitetssykehus HF
    • Contact: Tone Enge Berthelsen, MA; Email: UXBETG@ous-hf.no
  • Sandnessjøen, Norway, 8800
    • Recruiting
    • Psykiatrisk senter ytre Helgeland/Helgelandssykehuset HF
    • Contact: Gry E Konradsen, Psych Nurse; Email: Gry.Elin.Konradsen@Helgelandssykehuset.no
  • Sandvika, Norway, 1341
    • Recruiting
    • Bjerketun behandlingshjem/Vestreviken HF
    • Contact: Kristoffer Ødegård, MA; Email: oedkri@vestreviken.no
  • Trondheim, Norway, 7024
    • Recruiting
    • BUP Lian/St Olavs Hospital HF
    • Contact: Marthe Stornes, MA; Email: marthe.stornes@stolav.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dialectical Behaviour Therapy; Dialectical Behavior Therapy, delivered for 20 weeks for adolescents (DBT-A) or 52 weeks for adults (standard DBT.

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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-harm behaviour	Number of self-harm episodes (split on suicide attempts and non-suicidal self-harm)	4 weeks
Suicidal Ideation (adolescents)	Suicidal Ideation Questionnaire (SIQ-Jr). Min=0, Max=90. Higher scores indicate worse outcome	2 weeks
Depressive symptoms	MADRS (Montgomery Asberg Depression Rating Scale).Min=0, Max=60. Higher scores indicate worse outcome	1 week
Suicidal Ideation (adults)	Beck Scale for Suicidal Ideation (BSS). MIn=0, Max=38. Higher scores indicate worse outcome	4 weeks
Depressive symptoms (adolescents)	Moods and Feelings Questionnaire (MFQ). Min=0, Max=26. Higher scores indicate worse outcome	1 week
Depressive symptoms (adults)	Beck Depression Inventory (BDI). Min=0, Max=63. Higher scores indicate worse outcome	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borderline Symptoms	Borderline Symptom List (BSL-23). Min=0, Max=92. Higher scores indicate more symptoms.	1 week
Hopelessness	Beck Hopelessness Scale (BHS). Min=0, Max=20. Higher scores indicate more hopelessness.	1 week

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Vestre Viken Hospital Trust; University of Oslo; St. Olavs Hospital; Nordlandssykehuset HF; Sykehuset Ostfold
• Investigators: Principal Investigator: Lars Mehlum, MD PhD, University of Oslo

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: borderline personality disorder; self harm; emotional dysregulation; dialectical behaviour therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Personality Disorders; Borderline Personality Disorder; Self-Injurious Behavior
• Other Study ID Numbers: 2017/1247/REK sør-øst

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No