Abstract
BACKGROUND: Though evidence-based research about system constellations (SCs) appears marginal, it is applied in many psychiatric, psychological, and psychotherapeutic institutions as well as in different contexts of organizational counseling. To date, only one randomized controlled trial (RCT) has been conducted to assess the short- to long-term efficacy of SCs, which entail clients meeting at the same location in person. This study is to investigate the feasibility of a RCT investigating SCs in virtual reality (VR), and to calculate the number of clients needed for a confirmatory RCT. DESIGN: We will perform a prospective, monocentric, parallel-group, feasibility RCT with subsequent intervention. A total of 128 clients of 3-day group-based SC-VR seminars will be randomized to either the intervention group (IG; n = 64) or wait-list group (WLG; n = 64), which receives SCs in VR after 4 months. Feasibility and acceptability of the (1) research methodology and (2) intervention as well as the (3) estimation of effect sizes will be assessed using qualitative and quantitative data. Based on the model of a general mental health, the proposed primary outcome includes the SC-VR adherence, and the proposed secondary outcomes refer to psychological functioning (OQ-45.2), social system functioning (EXIS), psychological distress (FEP-2), motivational incongruence (INK-SF), and goal attainment (GAS). We plan to investigate the short-term efficacy at 2-week and 4-month follow-up within the RCT design (n = 128), and mid-term efficacy at 8- and 12-month follow-up for the intervention group (n = 64). DISCUSSION: The study is expected to be the first study on the feasibility of SC-VR. We will reflect on successfully implemented study procedures, and we will provide recommendations for changes considering the design, rationale, analyses, and interpretation of the study results where they became necessary. The discussion will conclude with an evaluation whether a confirmatory RCT on SC-VR is worth the investment of future resources, including the calculated number of clients needed based on the efficacy trends derived from this feasibility study. TRIAL REGISTRATION: ClinicalTrials.gov: ID = N CT05557890; date of registration: September 23, 2022; https://clinicaltrials.gov/ct2/show/NCT05557890 .