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Predictors of Clinical Course and Treatment Response in DBT Programmes

Primary Purpose

Self Harm, Borderline Personality Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Dialectical Behaviour Therapy adapted for adolescents (DBT-A)
Dialectical Behaviour Therapy - Standard version (DBT)
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self Harm focused on measuring self harm, dialectical behaviour therapy, borderline personality disorder, emotional dysregulation

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moss DPS/Østfold sykehus HFRecruiting
  • Søndre Oslo DPS/Oslo Universitetssykehus HFRecruiting
  • Psykiatrisk senter ytre Helgeland/Helgelandssykehuset HFRecruiting
  • Bjerketun behandlingshjem/Vestreviken HFRecruiting
  • BUP Lian/St Olavs Hospital HFRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dialectical Behaviour Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Borderline Symptoms
Borderline Symptom List (BSL-23). Min=0, Max=92. Higher scores indicate more symptoms.
Hopelessness
Beck Hopelessness Scale (BHS). Min=0, Max=20. Higher scores indicate more hopelessness.

Full Information

First Posted
March 4, 2020
Last Updated
March 21, 2023
Sponsor
Oslo University Hospital
Collaborators
Vestre Viken Hospital Trust, St. Olavs Hospital, Sykehuset Ostfold, University of Oslo, Nordlandssykehuset HF
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1. Study Identification

Unique Protocol Identification Number
NCT04318899
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Vestre Viken Hospital Trust, St. Olavs Hospital, Sykehuset Ostfold, University of Oslo, Nordlandssykehuset HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Harm, Borderline Personality Disorder
Keywords
self harm, dialectical behaviour therapy, borderline personality disorder, emotional dysregulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dialectical Behaviour Therapy
Arm Type
Experimental
Arm Description
Dialectical Behavior Therapy, delivered for 20 weeks for adolescents (DBT-A) or 52 weeks for adults (standard DBT.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behaviour Therapy adapted for adolescents (DBT-A)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behaviour Therapy - Standard version (DBT)
Intervention Description
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 Outcome Measure Information:
Title
Self-harm behaviour
Description
Number of self-harm episodes (split on suicide attempts and non-suicidal self-harm)
Time Frame
4 weeks
Title
Suicidal Ideation (adolescents)
Description
Suicidal Ideation Questionnaire (SIQ-Jr). Min=0, Max=90. Higher scores indicate worse outcome
Time Frame
2 weeks
Title
Depressive symptoms
Description
MADRS (Montgomery Asberg Depression Rating Scale).Min=0, Max=60. Higher scores indicate worse outcome
Time Frame
1 week
Title
Suicidal Ideation (adults)
Description
Beck Scale for Suicidal Ideation (BSS). MIn=0, Max=38. Higher scores indicate worse outcome
Time Frame
4 weeks
Title
Depressive symptoms (adolescents)
Description
Moods and Feelings Questionnaire (MFQ). Min=0, Max=26. Higher scores indicate worse outcome
Time Frame
1 week
Title
Depressive symptoms (adults)
Description
Beck Depression Inventory (BDI). Min=0, Max=63. Higher scores indicate worse outcome
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Borderline Symptoms
Description
Borderline Symptom List (BSL-23). Min=0, Max=92. Higher scores indicate more symptoms.
Time Frame
1 week
Title
Hopelessness
Description
Beck Hopelessness Scale (BHS). Min=0, Max=20. Higher scores indicate more hopelessness.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Egil Haga, PhD
Phone
+4722923442
Email
egil.haga@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Mehlum, MD PhD
Phone
+4722923442
Email
lars.mehlum@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Mehlum, MD PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moss DPS/Østfold sykehus HF
City
Moss
ZIP/Postal Code
1535
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Utne Haldorsen Kalla, MD
Email
eva.utne.haldorsen.kalla@so-hf.no
Facility Name
Søndre Oslo DPS/Oslo Universitetssykehus HF
City
Oslo
ZIP/Postal Code
1281
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tone Enge Berthelsen, MA
Email
UXBETG@ous-hf.no
Facility Name
Psykiatrisk senter ytre Helgeland/Helgelandssykehuset HF
City
Sandnessjøen
ZIP/Postal Code
8800
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gry E Konradsen, Psych Nurse
Email
Gry.Elin.Konradsen@Helgelandssykehuset.no
Facility Name
Bjerketun behandlingshjem/Vestreviken HF
City
Sandvika
ZIP/Postal Code
1341
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristoffer Ødegård, MA
Email
oedkri@vestreviken.no
Facility Name
BUP Lian/St Olavs Hospital HF
City
Trondheim
ZIP/Postal Code
7024
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marthe Stornes, MA
Email
marthe.stornes@stolav.no

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Linehan, M.M. (1993a). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press
Results Reference
background
Citation
Linehan, M.M. (1993b). Skills training manual for treating borderline personality disorder. New York: Guilford Press
Results Reference
background
Citation
Miller, A.L., Rathus J.H., Linehan, M.M. (2007). Dialectical behavioral therapy with suicidal adolescents. New York: Guilford Press
Results Reference
background

Learn more about this trial

Predictors of Clinical Course and Treatment Response in DBT Programmes

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