NCT05557890

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

September 23, 2022

Last Update Submit

May 6, 2024

Conditions

Keywords

Systems ConstellationVirtual Reality (VR)Feasibility Study

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline EB-45 Score within 4 months

    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 Outcomes (4)

  • Experience in Social Systems Questionnaire (EXIS)

    Baseline, 2 weeks after treatment, 4 months after treatment

  • Questionnaire for the Evaluation of Treatment Progress (FEP-2)

    Baseline, 2 weeks after treatment, 4 months after treatment

  • Bern Inventory of Psychotherapy Goals (BIT-C)

    Baseline, 2 weeks after treatment, 4 months after treatment

  • Incongruence Questionnaire (K-INK)

    Baseline, 2 weeks after treatment, 4 months after treatment

Study Arms (2)

System Constellation VR-Seminar (exp. group)

EXPERIMENTAL

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

System Constellation VR-Seminar (control group)

EXPERIMENTAL

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

Interventions

individual-centered intervention in a group VR-setting, duration 2 to 3 days

System Constellation VR-Seminar (control group)System Constellation VR-Seminar (exp. group)

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • acute suicidal tendency
  • acute psychotic episode
  • acute drug or alcohol intoxication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Witten/Herdecke University

Witten, North Rhine-Westphalia, 58455, Germany

Location

Related Publications (6)

  • Hunger C, Bornhauser A, Link L, Schweitzer J, Weinhold J. Improving experience in personal social systems through family constellation seminars: results of a randomized controlled trial. Fam Process. 2014 Jun;53(2):288-306. doi: 10.1111/famp.12051. Epub 2013 Nov 19.

    PMID: 24251855BACKGROUND
  • Hunger C, Weinhold J, Bornhauser A, Link L, Schweitzer J. Mid- and long-term effects of family constellation seminars in a general population sample: 8- and 12-month follow-up. Fam Process. 2015 Jun;54(2):344-58. doi: 10.1111/famp.12102. Epub 2014 Sep 29.

    PMID: 25264190BACKGROUND
  • Weinhold J, Hunger C, Bornhauser A, Link L, Rochon J, Wild B, Schweitzer J. Family constellation seminars improve psychological functioning in a general population sample: results of a randomized controlled trial. J Couns Psychol. 2013 Oct;60(4):601-9. doi: 10.1037/a0033539. Epub 2013 Aug 19.

    PMID: 23957767BACKGROUND
  • Hunger C, Bornhauser A, Link L, Geigges J, Voss A, Weinhold J, Schweitzer J. The Experience in Personal Social Systems Questionnaire (EXIS.pers): Development and Psychometric Properties. Fam Process. 2017 Mar;56(1):154-170. doi: 10.1111/famp.12205. Epub 2016 Feb 8.

    PMID: 26858173BACKGROUND
  • Hunger, C. (2020). Family constellations as single intervention within the group setting in chronic psychosocial conflicts: short-, medium-, and long-term efficacy.Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 68(4), 263-273.

    BACKGROUND
  • van Bebber T, Tappe EH, Druyen T, Kleve H, Rusen T, Hunger-Schoppe C. Efficacy and experience of system constellations in virtual reality (VR): study protocol for a randomized controlled feasibility study. Pilot Feasibility Stud. 2024 Dec 12;10(1):149. doi: 10.1186/s40814-024-01513-4.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Clinical Psychology and Psychotherapy III

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 28, 2022

Study Start

December 1, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations