System Constellations in Virtual Reality (VR) (SYSCO-VR)

May 6, 2024 updated by: Christina Hunger-Schoppe, University of Witten/Herdecke

Efficacy and Experience of System Constellations in Virtual Reality (VR): A Randomized Control Feasibility Study

The purpose of this study is to investigate the efficacy of system constellations in Virtual Reality (VR) in a monocentric, single-masked randomized controlled trial.

The method of system constellations refers to an approach which integrates ideas from organizational and family systems counseling with elements from psychodrama. The constellations are conducted in a group based VR-seminar, each VR-seminar lasting two to three days.

Based on the model of a general mental health, the effects of system constellations in VR on psychological and systems functioning are explored.

It is predicted that participation in a system constellation VR-seminar changes the level of psychological and systems functioning at 4 months.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

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

  • Germany
    • North Rhine-Westphalia
      • Witten, North Rhine-Westphalia, Germany, 58455
        • Witten/Herdecke University

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

No

Description

Inclusion Criteria:

  • agreement to participate in a 2 to 3-day system constellations VR-seminar
  • agreement to be randomized into treatment group or control group (waiting condition)
  • agreement not to participate in another system constellation VR-seminar or 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 Constellation VR-Seminar (exp. group)
By externalising significant elements, systemic constellations render the inner image someone has of a personally important social system in a visible and tangible way to get more clarity about psycho-social conflicts to make goal-oriented changes. In this study, the method System Constellation will be applied in a Virtual Reality (VR) setting during two to three day seminars.
Behavioral: System Constellation VR-Seminar
individual-centered intervention in a group VR-setting, duration 2 to 3 days
Experimental: System Constellation VR-Seminar (control group)
By externalising significant elements, systemic constellations render the inner image someone has of a personally important social system in a visible and tangible way to get more clarity about psycho-social conflicts to make goal-oriented changes. In this study, the method System Constellation will be applied in a Virtual Reality (VR) setting during two to three day seminars. Study participants randomized to this group receive the intervention (system constellations VR-seminar) 4 months after the experimental group.
Behavioral: System Constellation VR-Seminar
individual-centered intervention in a group VR-setting, duration 2 to 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline EB-45 Score within 4 months
Time Frame: Baseline, 2 weeks after treatment, 4 months after treatment
Changes in 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, 2 weeks after treatment, 4 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experience in Social Systems Questionnaire (EXIS)
Time Frame: Baseline, 2 weeks after treatment, 4 months after treatment
The subjective quality of family and organizational systems will be assessed by the EXIS (Questionnaire on experiences in systems), a self-constructed questionnaire comprising 24 items.
Baseline, 2 weeks after treatment, 4 months after treatment
Questionnaire for the Evaluation of Treatment Progress (FEP-2)
Time Frame: Baseline, 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, 2 weeks after treatment, 4 months after treatment
Bern Inventory of Psychotherapy Goals (BIT-C)
Time Frame: Baseline, 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)
Baseline, 2 weeks after treatment, 4 months after treatment
Incongruence Questionnaire (K-INK)
Time Frame: Baseline, 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, 2 weeks after treatment, 4 months after treatment

Collaborators and Investigators

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

Sponsor

University of Witten/Herdecke

Collaborators

FH Münster University of Applied Sciences
The Witten Institute For Family Business

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.

General Publications

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 (Actual)

December 1, 2023

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

September 23, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SYSCO-VR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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