- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Lieux d'étude
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Allemagne, 69115
- Institute of Medical Psychology, University Hospital Heidelberg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from Baseline in psychological well-being at 2 weeks and four months
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from Baseline in Psychological distress after 2 weeks and 4 months
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Jochen Schweitzer-Rothers, Professor, Institute of Medical Psychology, University Hospital Heidelberg/Germany
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- SFBC11
- SFB 619 project C11 (Autre identifiant: German Research Council)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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