VR-STEM: Virtual Reality Schema Therapy Exercises With Parent and Child Modes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Screened and enrolled patients per month
Study Overview
Brief Summary
The goal of this clinical trial is to develop a Virtual Reality version of a Schema Therapy exercise and test its feasibility, acceptability and potential usefulness in people with psychiatric disorders (age 18-65). The main questions the investigators aim to answer are:
- Are dialogue exercises with virtual reality mode avatars feasible, acceptable and useful?
- How do patients experience VR schema therapy exercises (in terms of immersion, elicited emotions, therapeutic relationship or subjective efficacy) and are the exercises potentially effective (in terms of schema mode scores, self-criticism, self-compassion and self-esteem)?
- In case of a potential 'effect', is this moderated by mental imagery ability?
The investigators hypothesize that 1) dialogue exercises with virtual reality mode avatars are feasible, ac-ceptable and useful according the Technology Acceptance Model (TAM; Davis, 1989); 2) patients experience high levels of immersion, elicited emotions and subjective efficacy, a strong therapeutic relationship, and show effects on schema mode scores and self-compassion and self-esteem scores; and 3) these effects are moderated by patients' mental imagery ability in such a way that patients with less mental imagery abilities benefit most.
The development of the VR version of the exercise will be done in collaboration with patients and therapists.
To test its feasibility, acceptability and potential usefulness, participants will be invited to receive one session of the exercise. During this session, they will complete some questionnaires before and after the exercise, and they will be asked about their opinions about and experiences of the exercise.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-65 years of age
- •In treatment at a tertiary treatment facility (UCP, UMCG)
- •Whose current psychological distress is related to early life experiences as indicated by a clinician
- •Score of >3 on one of three schema modes on the SMI (Lobbestael et al., 2010)
Exclusion Criteria
- •Insufficient command of the Dutch language
- •Primary diagnosis of a substance use disorder, or organic brain disease (such as dementia)
- •Unable to provide informed consent
Arms & Interventions
VR Schema Therapy Chairwork Exercise
The intervention consists of a schema therapy chairwork exercise in Virtual Reality
Intervention: VR Schema Therapy Chairwork Exercise (Behavioral)
Outcomes
Primary Outcomes
Screened and enrolled patients per month
Time Frame: From start to end of recruitment (+/- 10 months)
The amount of screened and enrolled patients per month will be registered to evaluate feasibility and acceptability.
Drop-outs
Time Frame: From start to end of recruitment (+/- 10 months)
Total number of drop-outs will be registered to evaluate feasibility and acceptability.
Reasons for withdrawal
Time Frame: From start to end of recruitment (+/- 10 months)
Reasons for withdrawal from the study will be registered to evaluate feasibility and acceptability
Total and types of adverse events
Time Frame: From start to end of recruitment (+/- 10 months)
The total number and types of adverse events will be registered to evaluate feasibility and acceptability.
Experienced issues during sessions
Time Frame: During the 2-hour sessions (From start to end of recruitment [+/- 10 months])
Experienced issues during sessions will be registered to evaluate feasibility and acceptability
Evaluative questions
Time Frame: At the end of the 2-hour intervention session (at post-intervention assessment)
A questionnaire based on the Technology Acceptance Model (TAM) will be completed by patients to evaluate their feedback, perceived usefulness, the added value, and their attitude towards VR schema therapy. This measure is used to evaluate feasibility and acceptability. It consists of 16 questions, divided into two subsections: subjective experience (8 questions) and Technology Acceptance Model (TAM) (8 questions). Questions are scored on a Likert scale ranging from 1 to 7 (total min. 16, max. 112; per subsection min. 8, max. 56). A lower score means a lower evaluation/more negative experience of the intervention, and a higher score means a higher evaluation/more positive experience with the intervention.
Patients qualitative first experiences
Time Frame: At the end of the 2-hour intervention session, after the post-intervention assessment
Patients qualitative first experiences with the Virtual Reality intervention will be measured using a qualitative, semi-structured interview at the end of each session, to evaluate feasibility and acceptability. Standard questions are: 1. How did you find the exercise? 2. What did you find positive about the exercise? (how can we make the positive aspects even more positive?) 3. What is missing from the exercise? (what can we improve?) The questions are intended as a guiding structure rather than a fixed questionnaire, and allow for additional follow-up questions to explore relevant topics further.
Secondary Outcomes
- Momentary Schema Modes Questionnaire (MSMQ)(At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention))
- Visual Analogue Scales(At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention))
- Self-Compassion and self-Criticism Scales (SCCS)(At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention))
- Immersion(At the end of the 2-hour intervention session (at post-intervention assessment))
- Therapeutic relationship(At the end of the 2-hour intervention session (post-intervention asessment))