Clinical trial NCT01512602: Efficacy of Dialectical Behavior Therapy Versus CAMS-informed Supportive Psychotherapy on Self Harming Behavior
Official title: Efficacy of Dialectical Behavior Therapy in Patient With Self Harming Behavior and Traits Within the Spectrum of Borderline Personality Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Suicide
Keywords: Borderline Personality Disorder traits
Suicide prevention
Self-harm
Dialectical Behavior Therapy
DBT
Collaborative Assessment and Management of Suicidology
CAMS
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
name: University of Copenhagen
First posted: 2012-01-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts).
timeFrame: Week 0 (baseline), 17, 28, 52.
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
measure: Impulsivity
timeFrame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
measure: Consumptions of services in hospital care.
timeFrame: After treatment period (16 weeks), Week 28 and 52 after inclusion
measure: Suicidal ideation
timeFrame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
measure: Severity of borderline personality disorder symptoms.
timeFrame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
measure: Anger
timeFrame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
measure: Hopelessness
timeFrame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.
measure: Self Esteem
timeFrame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
measure: Suicide related behavior.
timeFrame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.
Other outcomes:
Locations:
city: Copenhagen NV.
country: Denmark
facility: Mental Health Services, Research Unit, Bispebjerg
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.