NCT01512602

Brief Summary

Purpose: The purpose of this study is to investigate the efficacy of Dialectical Behavior Therapy (DBT) versus CAMS (Collaborative Assessment and Management of Suicidality) -informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self behavior and personality traits within the spectrum of borderline personality disorder. Hypothesis: The hypothesis is 16 weeks of treatment with Dialectical Behavior Therapy (DBT) after a defined manual has a higher efficacy than CAMS-informed supportive psychotherapy on self-harm acts, suicide attempts, suicidal ideation, depressive symptoms, impulsiveness and consumption of hospital services in patients with symptoms within the spectrum of borderline personality disorder (BDP). Method: The investigators will include 160 patients in the randomized trial to investigate whether 16 weeks of DBT-treatment as a higher efficacy than CAMS-informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self-harm behavior and personality traits within the spectrum of borderline personality disorder. The trial will meet strict criteria for high quality randomized trials, and will hopefully help to establish evidence for the treatment of this patient group at higher risk of later suicide. There will be performed follow up interviews after 16 weeks, 28 weeks and 52 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

2.5 years

First QC Date

December 21, 2011

Last Update Submit

April 25, 2015

Conditions

Borderline Personality DisorderSuicide

Keywords

Borderline Personality Disorder traitsSuicide preventionSelf-harmDialectical Behavior TherapyDBTCollaborative Assessment and Management of SuicidologyCAMS

Outcome Measures

Primary Outcomes (1)

  • Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts).

    This information will be obtained as self-reported and through journal entries.How many acts how has taken place between the different time points in the trial (week 0, 17,28, and 52) to actually quantify the self-harming acts in order to find out if the treatment in the two arms can decrease the numbers of self-harming acts, also long term effect (week 52).

    Week 0 (baseline), 17, 28, 52.

Secondary Outcomes (9)

  • Depressive symptoms

    Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion

  • Impulsivity

    Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion

  • Consumptions of services in hospital care.

    After treatment period (16 weeks), Week 28 and 52 after inclusion

  • Suicidal ideation

    Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion

  • Severity of borderline personality disorder symptoms.

    Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion

  • +4 more secondary outcomes

Study Arms (2)

Dialectical Behavior Therapy DBT

ACTIVE COMPARATOR

16 weeks DBT-treatment

Behavioral: DBT

CAMS

ACTIVE COMPARATOR

Collaborative Assessment and Management of Suicidality, CAMS-informed supportive psychotherapy

Behavioral: CAMS

Interventions

DBTBEHAVIORAL

16 weeks DBT treatment

Dialectical Behavior Therapy DBT
CAMSBEHAVIORAL

CAMS-informed psychotherapy

CAMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age.
  • A minimum of two characteristics in the DSM-IV Borderline Personality Disorder (BPD)
  • Informed consent.

You may not qualify if:

  • Severe depression.
  • Bipolar disorder.
  • Psychosis within the schizophrenic spectrum.
  • Anorexia Nervosa.
  • Substance abuse.
  • Mental retardation.
  • Dementia.
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Services, Research Unit, Bispebjerg

Copenhagen NV., 2400, Denmark

Location

Related Publications (4)

  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

    PMID: 33884617DERIVED

  • Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

    PMID: 32368793DERIVED

  • Andreasson K, Krogh J, Wenneberg C, Jessen HK, Krakauer K, Gluud C, Thomsen RR, Randers L, Nordentoft M. EFFECTIVENESS OF DIALECTICAL BEHAVIOR THERAPY VERSUS COLLABORATIVE ASSESSMENT AND MANAGEMENT OF SUICIDALITY TREATMENT FOR REDUCTION OF SELF-HARM IN ADULTS WITH BORDERLINE PERSONALITY TRAITS AND DISORDER-A RANDOMIZED OBSERVER-BLINDED CLINICAL TRIAL. Depress Anxiety. 2016 Jun;33(6):520-30. doi: 10.1002/da.22472. Epub 2016 Feb 8.

    PMID: 26854478DERIVED

  • Andreasson K, Krogh J, Rosenbaum B, Gluud C, Jobes DA, Nordentoft M. The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial. Trials. 2014 May 29;15:194. doi: 10.1186/1745-6215-15-194.

    PMID: 24885904DERIVED

MeSH Terms

Conditions

Borderline Personality DisorderSuicideSuicide PreventionSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

December 21, 2011

First Posted

January 19, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

DK(1)