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

NCT ID: NCT01512602

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Borderline Personality Disorder Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Dialectical Behavior Therapy DBT

16 weeks DBT-treatment

Group Type ACTIVE_COMPARATOR

DBT

Intervention Type BEHAVIORAL

16 weeks DBT treatment

CAMS

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

Group Type ACTIVE_COMPARATOR

CAMS

Intervention Type BEHAVIORAL

CAMS-informed psychotherapy

Interventions

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DBT

16 weeks DBT treatment

Intervention Type BEHAVIORAL

CAMS

CAMS-informed psychotherapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lundbeck Foundation

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Merete Nordentoft

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mental Health Services, Research Unit, Bispebjerg

Copenhagen NV., , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33884617 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32368793 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26854478 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24885904 (View on PubMed)

Other Identifiers

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RHP-DiaS-002

Identifier Type: -

Identifier Source: org_study_id

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