Efficacy of System Constellations in a General Population

Psychological Well-being Clinical Trial

Official title:

Randomized Controlled Trial on the Efficacy of System Constellations on Psychological Well-being in a General Population Based Sample

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352325
• Other study ID #: SFBC11
• Secondary ID: SFB 619 project
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 4, 2011
• Last updated: February 8, 2012
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychological Well-being

Intervention

Behavioral:
• system constellations seminar
individual-centered intervention in a group setting, duration 3 days
• system constellations seminar
individual-centered intervention in a group setting, duration 3 days

Locations

Country	Name	City	State
Germany	Institute of Medical Psychology, University Hospital Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in psychological well-being at 2 weeks and four months	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	No
Secondary	Change from Baseline in Psychological distress after 2 weeks and 4 months	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	No
Secondary	Change from Baseline in Incongruence at 2 weeks and 4 months	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	No
Secondary	Goal achievement at 2 weeks and 4 months	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	No
Secondary	Change from Baseline in 'Experiences in family and organisational systems' at 2 weeks and 4 months	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	No