虚拟现实（VR）中系统排列的疗效与经验：一项随机对照可行性研究的研究方案

Efficacy and experience of system constellations in virtual reality (VR): study protocol for a randomized controlled feasibility study.

作者信息

van Bebber Tobias, Tappe Eik-Henning, Druyen Thomas, Kleve Heiko, Rüsen Tom, Hunger-Schoppe Christina

机构信息

Clinical Psychology and Psychotherapy III, Faculty of Health (Department of Psychology and Psychotherapy), Witten/Herdecke University, Alfred-Herrhausen-Str. 50, Witten, 58455, Germany.

Department of Social Work (Teaching and Research Area: Digitization and Media Pedagogy in Social Work), University of Applied Science Münster, Friesenring 32, Münster, 48147, Germany.

出版信息

Pilot Feasibility Stud. 2024 Dec 12;10(1):149. doi: 10.1186/s40814-024-01513-4.

DOI:10.1186/s40814-024-01513-4

PMID:39668350

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11636043/

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 .

摘要

背景

尽管关于系统排列（SCs）的循证研究似乎较少，但它已在许多精神科、心理科和心理治疗机构以及组织咨询的不同背景中得到应用。迄今为止，仅进行了一项随机对照试验（RCT）来评估系统排列的短期至长期疗效，系统排列要求来访者亲自在同一地点会面。本研究旨在调查一项在虚拟现实（VR）中研究系统排列的随机对照试验的可行性，并计算验证性随机对照试验所需的来访者数量。

设计

我们将进行一项前瞻性、单中心、平行组、可行性随机对照试验，并随后进行干预。总共128名参加为期3天的基于小组的系统排列 - 虚拟现实研讨会的来访者将被随机分为干预组（IG；n = 64）或等待名单组（WLG；n = 64），等待名单组在4个月后接受虚拟现实中的系统排列。将使用定性和定量数据评估（1）研究方法、（2）干预措施的可行性和可接受性以及（3）效应大小的估计。基于一般心理健康模型，拟议的主要结局包括系统排列 - 虚拟现实的依从性，拟议的次要结局包括心理功能（OQ - 45.2）、社会系统功能（EXIS）、心理困扰（FEP - 2）、动机不一致（INK - SF）和目标达成（GAS）。我们计划在随机对照试验设计（n = 128）中调查2周和4个月随访时的短期疗效，以及干预组（n = 64）在8个月和12个月随访时的中期疗效。