Trial document





This trial has been registered retrospectively.
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  DRKS00011534

Trial Description

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Title

PRO*BPD: Effectiveness of outpatient treatment PROgrammes for Borderline Personality Disorder: A comparison of Schema Therapy and Dialectical Behaviour Therapy

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Trial Acronym

PROBPD

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URL of the Trial

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Brief Summary in Lay Language

Borderline Personality Disorder (BPD) is a severe, highly prevalent mental disorder associated with low quality of life and low psychosocial functioning as well as high treatment costs. Treatment of BPD has improved within the last decades. Dialectical behavior therapy (DBT) and Schema therapy (ST) have demonstrated efficacy in reducing BPD symptoms. However there is a lack of 'real world studies' replicating the positive results in regular mental healthcare settings. Further there is no study comparing these two methods.
The ProBPD study will be the first randomized controlled trial to compare the effectiveness of DBT and ST within the routine clinical setting of an outpatient clinic. 128 consecutive BPD patients will be randomly assigned to either DBT or ST (64 per treatment condition). In both conditions, patients receive one group therapy session and one individual therapy session per week for a maximum of 18 months. Treatment may stop earlier if patients recover. The primary outcome is reduction of BPD typical symptoms. Further outcomes address quality od life, psychosocial functioning and participation, treatment costs and course of other psychiatric disorders. Data will be assessed before start of therapy and then every 6 months until the end of therapy as well as one and two years after the end of therapy.

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Brief Summary in Scientific Language

Borderline Personality Disorder (BPD) is a severe, highly prevalent mental disorder associated with low quality of life and low psychosocial functioning as well as high treatment costs. Treatment of BPD has improved within the last decades. Dialectical behavior therapy (DBT) and Schema therapy (ST) have demonstrated efficacy in reducing BPD symptoms. However there is a lack of 'real world studies' replicating the positive results in regular mental healthcare settings. Further there is no study comparing these two methods.
The ProBPD study will be the first randomized controlled trial to compare the effectiveness of DBT and ST within the routine clinical setting of an outpatient clinic. 128 consecutive BPD patients will be randomly assigned to either DBT or ST (64 per treatment condition). In both conditions, patients receive one group therapy session and one individual therapy session per week for a maximum of 18 months. The primary outcome is reduction of BPD typical symptoms. Further outcomes address quality of life, psychosocial functioning and participation, treatment costs and course of other psychiatric disorders. Data will be assessed before start of therapy and then every 6 months until the end of therapy as well as one and two years after the end of therapy. By means of an explorative data analysis, possible moderator and mediator variables (e.g. sex, age, severity of BPD-symptoms, comorbidity, traumatic experiences during childhood, experiential avoidance) will be addressed. Lastly, a qualitative study on patients' and therapists' experiences with the two methods will be carried out.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011534
  •   2017/01/11
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  •   yes
  •   Approved
  •   13-005, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   F60.31 -  [generalization F60.3: Emotionally unstable personality disorder]
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Interventions/Observational Groups

  •   Intensive outpatient treatment program of ST with one individual and one group session per week for 1.5 years
  •   Intensive outpatient treatment program of DBTwith one individual and one group session per week for 1.5 years
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Change in BPD symptom severity assessed with the mean score of the Borderline-Personality Disorder Severity Index at 1 year follow up.

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Secondary Outcome

Change in quality of life measured with EQ-5D and WHOQoL, social functioning and participation measured with GAF-SOFAS, Cost-effectiveness measured with a COST-Interview, comorbidity (SKID I and II), general psychiatric symptoms (BSI, QIDS), other measures of BPD-psychopathology (dissociation, emotion regulation skills, experiential avoidance) at one year follow-up.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/26
  •   128
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Primary DSM-IV diagnosis of BPD (diagnosed by SCID-II interview)
Severity of BPD > 20 points in the BPDSI interview (this is a empirically derived severity criterion, distinguishing BPD pathology from other PD-pathology)
Willingness to participate in the study (informed consent)
Willingness and ability to remain for 1.5 years in the study and to participate reliably in therapy (no relocation plans etc.)

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Exclusion Criteria

Major psychotic disorder (lifetime diagnosis
Intellectual deficits (IQ<85)
Inadequate German language skills
Acute serious substance dependencies (DSM-IV) that cause severe cognitive restrictions during therapy and which calls for detoxification treatment. Participation is possible after detox treatment and a four weeks abstinence period.

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Addresses

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    • Klinik für Psychiatrie und Psychotherapie, Universität zu Lübeck
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie, Universität zu Lübeck
    • Ms.  Dr. med.  Eva  Faßbinder 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie, Universität zu Lübeck
    • Ms.  Dr. med.  Eva  Faßbinder 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Universität zu LübeckKlinik für Psychiatrie und Psychotherapie
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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