Efficacy of System Constellations in a General Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jochen Schweitzer-Rothers, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01352325
First received: May 4, 2011
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Psychological Well-being
Behavioral: system constellations seminar
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on the Efficacy of System Constellations on Psychological Well-being in a General Population Based Sample

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Goal achievement at 2 weeks and 4 months [ Time Frame: day of treatment, 2 weeks after treatment, 4 months after treatment ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 216
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: system constellations seminar
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.
Behavioral: system constellations seminar
individual-centered intervention in a group setting, duration 3 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352325

Locations
Germany
Institute of Medical Psychology, University Hospital Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69115
Sponsors and Collaborators
Heidelberg University
Investigators
Study Director: Jochen Schweitzer-Rothers, Professor Institute of Medical Psychology, University Hospital Heidelberg/Germany
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jochen Schweitzer-Rothers, Professor, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01352325     History of Changes
Other Study ID Numbers: SFBC11, SFB 619 project C11
Study First Received: May 4, 2011
Last Updated: February 8, 2012
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on July 22, 2014