Predictors of Clinical Course and Treatment Response in DBT Programmes

NCT04318899 | Recruiting

• 1 other identifier: 2017/1247/REK sør-øst
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 5

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.

Conditions

Self Harm; Borderline Personality Disorder

Keywords

self harm; dialectical behaviour therapy; borderline personality disorder; emotional dysregulation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Borderline Symptoms

  1 week

• Hopelessness

  1 week

Study Arms (1)

Dialectical Behaviour Therapy

EXPERIMENTAL

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); Behavioral: Dialectical Behaviour Therapy - Standard version (DBT)

Interventions

Dialectical Behaviour Therapy adapted for adolescents (DBT-A) BEHAVIORAL

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

Dialectical Behaviour Therapy - Standard version (DBT) BEHAVIORAL

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.

Dialectical Behaviour Therapy

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Psychotic disorders
• Anorexia Nervosa
• Substance dependence disorder
• Mental retardation (IQ less than 70)
• Asperger syndrome/autism

Sponsors & Collaborators

• Oslo University Hospital: lead
• Vestre Viken Hospital Trust: collaborator
• St. Olavs Hospital: collaborator
• Sykehuset Ostfold: collaborator
• University of Oslo: collaborator
• Nordlandssykehuset HF: collaborator

Study Sites (5)

Søndre Oslo DPS/Oslo Universitetssykehus HF

Oslo, Oslo County, 1281, Norway

RECRUITING

Moss DPS/Østfold sykehus HF

Moss, 1535, Norway

RECRUITING

Psykiatrisk senter ytre Helgeland/Helgelandssykehuset HF

Sandnessjøen, 8800, Norway

RECRUITING

Bjerketun behandlingshjem/Vestreviken HF

Sandvika, 1341, Norway

RECRUITING

BUP Lian/St Olavs Hospital HF

Trondheim, 7024, Norway

RECRUITING

Related Publications (3)

• Linehan, M.M. (1993a). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press

  BACKGROUND

• Linehan, M.M. (1993b). Skills training manual for treating borderline personality disorder. New York: Guilford Press

  BACKGROUND

• Miller, A.L., Rathus J.H., Linehan, M.M. (2007). Dialectical behavioral therapy with suicidal adolescents. New York: Guilford Press

  BACKGROUND

MeSH Terms

Conditions

Self-Injurious Behavior; Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personality Disorders; Mental Disorders

Study Officials

• Lars Mehlum, MD PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Egil Haga, PhD

CONTACT

+4722923442; egil.haga@medisin.uio.no

Lars Mehlum, MD PhD

CONTACT

+4722923442; lars.mehlum@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor dr med

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 24, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5)