- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01352325
Efficacy of System Constellations in a General Population
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Luoghi di studio
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Germania, 69115
- Institute of Medical Psychology, University Hospital Heidelberg
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from Baseline in psychological well-being at 2 weeks and four months
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from Baseline in Psychological distress after 2 weeks and 4 months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Jochen Schweitzer-Rothers, Professor, Institute of Medical Psychology, University Hospital Heidelberg/Germany
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- SFBC11
- SFB 619 project C11 (Altro identificatore: German Research Council)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .