Trial document




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  DRKS00013266

Trial Description

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Title

Schema Therapy for inpatients with personality disorders

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Schema Therapy is a specific psychotherapy form for patients with personality disorders. ST has been proven to be very effective while working with outpatients. This study investigates the effectiveness of ST in the treatment of inpatients suffering from PD.
20 adult inpatients between 18 and 65 years suffering from specific PD will be given a ST treatment protocol. Excluded will be patients suffering from intelligence reduction, ADD, organic mental disorders, psychotic disorders, antisocial PD and severe depression. Also excluded will be patients who received inpatient psychotherapy in the last 6 months and patients being treated with benzodiazepines and opioid painkillers.
After screening and a waiting time between 4 and 10 weeks participants will be admitted in the psychosomatic medicine department of the psychiatric hospital Klinikum am Weissenhof in Weinsberg, Germany. Treatment protocol is 12 weeks long. Psychopathology and therapy progress will be assessed using various psychological tests. Follow up screenings will take place 3 months after treatment end.

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Brief Summary in Scientific Language

Schema Therapy is a specific psychotherapy form for patients with personality disorders. ST has been proven to be very effective while working with outpatients. This study investigates the effectiveness of a ST treatment protocol for inpatients suffering from PD consisting in individual schema therapy, group schema therapy, nurse co-therapy, art therapy, sport therapy, music therapy and body therapy. .
20 adult inpatients between 18 and 65 years suffering from specific PD will be given a ST treatment protocol. Excluded will be patients suffering from ADD, organic mental disorders, psychotic disorders, antisocial PD and severe depression. Also excluded will be patients who received inpatient psychotherapy in the last 6 months and patients being treated with benzodiazepines and opioid painkillers.
This study is a concurrent multiple baseline design with a baseline varying in length from 4 to 10 weeks. There is one treatment condition (10 week protocol) and two control conditions (baseline and exploration) in a within-subject design, without a control group.
A total of 30 participants will be screened for eligibility. Screenings will be scheduled in November and in January, 15 participants per date. The screening procedure consists of 2 sessions in which patients are screened for eligibility to participate, based on the inclusion and exclusion criteria and in which 3 negative core beliefs are formulated.
The first 10 participants out of each group of 15 meeting criteria will be recruited. The allocation to different baseline lengths will be randomized. A series of psychological tests will be used at 5 different stages of treatment to assess psychopathology: SCL-90, BDI-II, FLZ (Life satisfaction questionnaire). A specific Schema Therapy questionnaire (Schema Mode Inventory SMI) will be used to assess treatment progress. In direct discussion with each participant, three idiosyncratic beliefs will be formulated that are central to the participant's problems. Participants will rate the degree to which they believe in each statement on 100 mm visual analogue scales (VAS) daily during baseline, attention control and treatment as well as in the last 2 weeks at follow-up.
Mixed regression analysis will be used to assess the differences between the exploration, treatment and follow-up phases compared to the baseline phase. The effect of time will be tested by the linear time trend over the whole study period, with first baseline assessment as zero time point. Condition will be tested by 4 levels: baseline, exploration phase, intervention phase and follow-up phase. Time-within-treatment will be tested by centered linear time effects within each of the conditions.

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Organizational Data

  •   DRKS00013266
  •   2017/11/03
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  •   yes
  •   Approved
  •   F-2017-068, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   F60 -  Specific personality disorders
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Interventions/Observational Groups

  •   Baseline (4-10 weeks): psychological tests at baseline start, participants will rate the degree to which they believe in each of the 3 Belief Strength (negative core beliefs) as well as their emotional acceptance and self satisfaction by VAS daily.
    Exploration phase (2 weeks starting at clinical admission): tests at admission and daily VAS. 4 exploration and psychoeducation sessions, no further therapy interventions.
    Intervention phase (10 weeks): tests at treatment beginning and end, daily VAS. Schema Therapy treatment protocol consisting in 2 weekly sessions individual therapy (50 min), 2 weekly sessions group schema therapy (90 min each), group art therapy, group sports therapy, group music therapy and individual group therapy.
    3 months Follow up: tests, VAS daily 2 weeks before screening.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   N/A
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Primary Outcome

The average scores (mean) in all 4 conditions (baseline, attention control, intervention, follow up) of the daily assessment by VAS (visual analog scale) of the following parameters:
Belief strength regarding 3 negative core beliefs.
Emotional acceptance.
Self satisfaction.

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Secondary Outcome

Assessments before baseline, at the beginning of the attention control phase, before and after the intervention phase and at 3 months follow up: SCL-90 (symptom check list), BDI-II (Beck’s depression inventory), SMI (Schema Mode Inventory), FLZ (Life satisfaction questionnaire).

Assessments before baseline and at 3 months follow up: PD criteria assessed with the Structured Clinical Interview for Axis II Personality Disorders (SCID-II)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/11/06
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Participants must be between 18 and 65 years old and suffer from specific or combined PD (verified using SCID-II). Participants must be fluid in German.

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Exclusion Criteria

Excluded will be patients suffering from significant intelligence reduction, ADD, organic mental disorders, psychotic disorders, antisocial PD and severe depression. Also excluded will be patients who received inpatient psychotherapy in the last 6 months and patients being treated with benzodiazepines and opioid painkillers.

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Addresses

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    • Klinik für Psychosomatische Medizin und Psychotherapie - Klinikum am Weissenhof
    • Weissenhof
    • 74189  Weinsberg
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie - Klinikum am Weissenhof
    • Mr.  Dr.  Matias  Valente 
    • Weissenhof
    • 74189  Weinsberg
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie - Klinikum am Weissenhof
    • Mr.  Dr.  Matias  Valente 
    • Weissenhof
    • 74189  Weinsberg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychosomatische Medizin und Psychotherapie - Klinikum am Weissenhof
    • Weissenhof
    • 74189  Weinsberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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