Efficacy of System Constellations in a General Population

February 8, 2012 updated by: 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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69115
        • Institute of Medical Psychology, University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: system constellations seminar (exp. group)
Study participants randomized to this group receive the intervention (system constellation seminar) 4 months prior to the control group
individual-centered intervention in a group setting, duration 3 days
Experimental: system constellations seminar (control group)
Study participants randomized to this group receive the intervention (system constellations seminar) 4 months after the experimental group.
individual-centered intervention in a group setting, duration 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in psychological well-being at 2 weeks and four months
Time Frame: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
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.
Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Psychological distress after 2 weeks and 4 months
Time Frame: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
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.
Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
Change from Baseline in Incongruence at 2 weeks and 4 months
Time Frame: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
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.
Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
Goal achievement at 2 weeks and 4 months
Time Frame: day of treatment, 2 weeks after treatment, 4 months after treatment
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).
day of treatment, 2 weeks after treatment, 4 months after treatment
Change from Baseline in 'Experiences in family and organisational systems' at 2 weeks and 4 months
Time Frame: day of treatment, 2 weeks after treatment, 4 months after treatment
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.
day of treatment, 2 weeks after treatment, 4 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jochen Schweitzer-Rothers, Professor, Institute of Medical Psychology, University Hospital Heidelberg/Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

May 10, 2011

First Posted (Estimate)

May 11, 2011

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • SFBC11
  • SFB 619 project C11 (Other Identifier: German Research Council)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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