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Borderline Personality DisorderDiaSNCT01512602

Efficacy of Dialectical Behavior Therapy Versus CAMS-informed Supportive Psychotherapy on Self Harming Behavior

A study testing DBT and CAMS in people with Borderline Personality Disorder and Suicide, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Borderline Personality Disorder, Suicide
What is being tested?
DBT and CAMS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteDenmark
Study dates
Jan 2012to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-65 years of age.
  • Newly suicide attempt within one month of the inclusion date.
  • A minimum of two characteristics in the DSM-IV Borderline Personality Disorder (BPD)
  • Informed consent.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Mental Health Services, Research Unit, Bispebjerg

    Copenhagen NV., 2400

Other trials in Denmark

About this study

Official title: Efficacy of Dialectical Behavior Therapy in Patient With Self Harming Behavior and Traits Within the Spectrum of Borderline Personality Disorder.

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.

Being tested
DBT, CAMS
Keywords
Borderline Personality Disorder traits, Suicide prevention, Self-harm, Dialectical Behavior Therapy, DBT, Collaborative Assessment and Management of Suicidology, CAMS
Medical subject headings
Borderline Personality Disorder, Suicide, Suicide Prevention, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DBTBehavioural

    16 weeks DBT treatment

  • CAMSBehavioural

    CAMS-informed psychotherapy

Study groups in NCT01512602
Study groupRoleWhat they receive
Dialectical Behavior Therapy DBTActive comparator16 weeks DBT-treatment
Receives: Behavioral: DBT
CAMSActive comparatorCollaborative Assessment and Management of Suicidality, CAMS-informed supportive psychotherapy
Receives: Behavioral: CAMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (9)

  1. Depressive symptoms

    Measured by HDRS-17 and BDI.

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

  2. Impulsivity

    Measured by Barratts Impulsivity Scale (BIS-11)

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

  3. Consumptions of services in hospital care.

    Register based information: Contact with hospital contact with code 4 (self-harm act), or suicide attemp X60-X84, or poisioning by weak analgesia (T39), hypnotics (T52), or psychothopic drugs (T43). Vital status, causes of death, use of bed days and outpatients services.

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

  4. Suicidal ideation

    Measured by Beck's Suididal Ideation Scale (SSI-21)

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

  5. Severity of borderline personality disorder symptoms.

    Measured by Zanarini Borderline Personality Scale.

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

  6. Anger

    Measured by State Trait Anger Scale.

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

  7. Hopelessness

    Measured by Becks Hopelessness Scale.

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

  8. Self Esteem

    Measured by Rosenbergs Self esteem Scale (RSE).

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

  9. Suicide related behavior.

    Measured by Suicide Attempt Self Injury Interview (SASII) and Beck's suicide intent Scale

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01512602
Sponsor's protocol ID
RHP-DiaS-002
Acronym
DiaS
Status last verified
Apr 2015
First submitted
21 Dec 2011
Last updated
28 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33884617

  • 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.

    PubMed 32368793

  • 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.

    PubMed 26854478

  • 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.

    PubMed 24885904

Questions about this trial

What is this clinical trial studying?

A study testing DBT and CAMS in people with Borderline Personality Disorder and Suicide, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (time frame: Week 0 (baseline), 17, 28, 52.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01512602, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.

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