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Clinical Trials/NCT01352325
NCT01352325CompletedPhase 2

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

Heidelberg University1 site in 1 country216 target enrollmentStarted: February 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
216
Locations
1
Primary Endpoint
Change from Baseline in psychological well-being at 2 weeks and four months

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

system constellations seminar (exp. group)

Experimental

Study participants randomized to this group receive the intervention (system constellation seminar) 4 months prior to the control group

Intervention: system constellations seminar (Behavioral)

system constellations seminar (control group)

Experimental

Study participants randomized to this group receive the intervention (system constellations seminar) 4 months after the experimental group.

Intervention: system constellations seminar (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change from Baseline in Psychological distress after 2 weeks and 4 months(Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment)
  • Change from Baseline in Incongruence at 2 weeks and 4 months(Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment)
  • Goal achievement at 2 weeks and 4 months(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(day of treatment, 2 weeks after treatment, 4 months after treatment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jochen Schweitzer-Rothers

Professor

Heidelberg University

Study Sites (1)

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