Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictors of Clinical Course and Treatment Response in DBT Programmes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318899
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
Vestre Viken Hospital Trust
St. Olavs Hospital
Sykehuset Ostfold
University of Oslo
Nordlandssykehuset HF
Information provided by (Responsible Party):
Lars Mehlum, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Self Harm Borderline Personality Disorder Behavioral: Dialectical Behaviour Therapy adapted for adolescents (DBT-A) Behavioral: Dialectical Behaviour Therapy - Standard version (DBT) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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.




Primary Outcome Measures :
  1. Self-harm behaviour [ Time Frame: 4 weeks ]
    Number of self-harm episodes (split on suicide attempts and non-suicidal self-harm)

  2. Suicidal Ideation (adolescents) [ Time Frame: 2 weeks ]
    Suicidal Ideation Questionnaire (SIQ-Jr). Min=0, Max=90. Higher scores indicate worse outcome

  3. Depressive symptoms [ Time Frame: 1 week ]
    MADRS (Montgomery Asberg Depression Rating Scale).Min=0, Max=60. Higher scores indicate worse outcome

  4. Suicidal Ideation (adults) [ Time Frame: 4 weeks ]
    Beck Scale for Suicidal Ideation (BSS). MIn=0, Max=38. Higher scores indicate worse outcome

  5. Depressive symptoms (adolescents) [ Time Frame: 1 week ]
    Moods and Feelings Questionnaire (MFQ). Min=0, Max=26. Higher scores indicate worse outcome

  6. Depressive symptoms (adults) [ Time Frame: 1 week ]
    Beck Depression Inventory (BDI). Min=0, Max=63. Higher scores indicate worse outcome


Secondary Outcome Measures :
  1. Borderline Symptoms [ Time Frame: 1 week ]
    Borderline Symptom List (BSL-23). Min=0, Max=92. Higher scores indicate more symptoms.

  2. Hopelessness [ Time Frame: 1 week ]
    Beck Hopelessness Scale (BHS). Min=0, Max=20. Higher scores indicate more hopelessness.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318899


Contacts
Layout table for location contacts
Contact: Egil Haga, PhD +4722923442 egil.haga@medisin.uio.no
Contact: Lars Mehlum, MD PhD +4722923442 lars.mehlum@medisin.uio.no

Locations
Layout table for location information
Norway
Moss DPS/Østfold sykehus HF Recruiting
Moss, Norway, 1535
Contact: Eva Utne Haldorsen Kalla, MD       eva.utne.haldorsen.kalla@so-hf.no   
Søndre Oslo DPS/Oslo Universitetssykehus HF Recruiting
Oslo, Norway, 1281
Contact: Tone Enge Berthelsen, MA       UXBETG@ous-hf.no   
Psykiatrisk senter ytre Helgeland/Helgelandssykehuset HF Recruiting
Sandnessjøen, Norway, 8800
Contact: Gry E Konradsen, Psych Nurse       Gry.Elin.Konradsen@Helgelandssykehuset.no   
Bjerketun behandlingshjem/Vestreviken HF Recruiting
Sandvika, Norway, 1341
Contact: Kristoffer Ødegård, MA       oedkri@vestreviken.no   
BUP Lian/St Olavs Hospital HF Recruiting
Trondheim, Norway, 7024
Contact: Marthe Stornes, MA       marthe.stornes@stolav.no   
Sponsors and Collaborators
Oslo University Hospital
Vestre Viken Hospital Trust
St. Olavs Hospital
Sykehuset Ostfold
University of Oslo
Nordlandssykehuset HF
Investigators
Layout table for investigator information
Principal Investigator: Lars Mehlum, MD PhD University of Oslo
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

Layout table for additonal information
Responsible Party: Lars Mehlum, Professor dr med, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04318899    
Other Study ID Numbers: 2017/1247/REK sør-øst
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lars Mehlum, Oslo University Hospital:
self harm
dialectical behaviour therapy
borderline personality disorder
emotional dysregulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Personality Disorders
Borderline Personality Disorder
Self-Injurious Behavior
Mental Disorders
Behavioral Symptoms