Efficacy of System Constellations in a General Population
8. februar 2012 opdateret af: Jochen Schweitzer-Rothers, Heidelberg University
Randomized Controlled Trial on the Efficacy of System Constellations on Psychological Well-being in a General Population Based Sample
The purpose of this study is to investigate the efficacy of system constellations in a monocentric, single-masked randomized controlled trial.
The method of system constellations refers to an approach which integrates ideas from family systems therapy with elements from psychodrama. The constellations are conducted in a group based seminar-setting, each seminar lasting three days.
Based on the model of a general psychotherapy and the consistency theory, the effects of system constellations on psychological functioning are explored.
It is predicted that participation in a system constellation seminar changes the level of psychological functioning at 4 months.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
216
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Tyskland, 69115
- Institute of Medical Psychology, University Hospital Heidelberg
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- agreement to participate in a 3-day system constellations seminar
- agreement to be randomized into treatment group or control group (waiting condition)
- agreement not to participate in another system constellation seminar until completion of study
Exclusion Criteria:
- acute suicidal tendency
- acute psychotic episode
- acute drug or alcohol intoxication
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: system constellations seminar (exp. group)
Study participants randomized to this group receive the intervention (system constellation seminar) 4 months prior to the control group
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individual-centered intervention in a group setting, duration 3 days
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Eksperimentel: system constellations seminar (control group)
Study participants randomized to this group receive the intervention (system constellations seminar) 4 months after the experimental group.
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individual-centered intervention in a group setting, duration 3 days
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in psychological well-being at 2 weeks and four months
Tidsramme: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
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Psychological well-being will be assessed using the 'Outcome Questionnaire' in its German version (EB-45).
The EB-45 is a brief 45-item self report outcome/tracking instrument designed for repeated measurement of client progress through the course of psychotherapy and following termination.
The scales of the EB-45 measure symptom distress, interpersonal functioning, and social role.
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Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in Psychological distress after 2 weeks and 4 months
Tidsramme: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
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The FEP-2, 40-item self report questionnaire, measures psychological distress according to the phase model of therapeutic change as well as the interpersonal model of psychological distress.
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Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
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Change from Baseline in Incongruence at 2 weeks and 4 months
Tidsramme: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
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Motivational incongruence is defined as the unsatisfactory realization of motivational goals and is based on the concept of General Psychotherapy by Klaus Grawe.
The Incongruence Questionnaire (INK) is an instrument that assesses motivational incongruence, defined as the discrepancy between a person's motivational goals and his/her perception of reality.
The short version of this questionnaire that will be used in our study (K-INK) comprises 23 items.
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Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
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Goal achievement at 2 weeks and 4 months
Tidsramme: day of treatment, 2 weeks after treatment, 4 months after treatment
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Goal achievement will be assessed using Goal Attainment Scaling as a method for the assimilation of achievement in a number of individually set goals into a single aggregated 'goal attainment score', providing a person-centred outcome, focused on that individual's priorities.
Goal attainment scaling is operationalized by an open-ended question, in which study participants descriobe their individual goals.
In a second step these goals will be coded according to the Bern inventory of psychotherapy goals (BIT-C).
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day of treatment, 2 weeks after treatment, 4 months after treatment
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Change from Baseline in 'Experiences in family and organisational systems' at 2 weeks and 4 months
Tidsramme: day of treatment, 2 weeks after treatment, 4 months after treatment
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The subjective quality of family and organizational systems will be assessed by the HFES (Heidelberger Fragebogen zum Erleben in Systemen: Heidelberg Questionnaire on experiences in systems), a self-constructed questionnaire comprising 24 items.
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day of treatment, 2 weeks after treatment, 4 months after treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Jochen Schweitzer-Rothers, Professor, Institute of Medical Psychology, University Hospital Heidelberg/Germany
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2011
Primær færdiggørelse (Faktiske)
1. december 2011
Studieafslutning (Faktiske)
1. december 2011
Datoer for studieregistrering
Først indsendt
4. maj 2011
Først indsendt, der opfyldte QC-kriterier
10. maj 2011
Først opslået (Skøn)
11. maj 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. februar 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. februar 2012
Sidst verificeret
1. februar 2012
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SFBC11
- SFB 619 project C11 (Anden identifikator: German Research Council)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .