Virtual Reality Schema Therapy Exercises With Parent and Child Modes

NCT07373223 | Recruiting

• 1 other identifier: 22811
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

1. 1.Are dialogue exercises with virtual reality mode avatars feasible, acceptable and useful?
2. 2.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)?
3. 3.In case of a potential 'effect', is this moderated by mental imagery ability?

Conditions

Psychiatric Disorders

Keywords

Virtual Reality Schema Therapy

Outcome Measures

Primary Outcomes (7)

• Screened and enrolled patients per month

  The amount of screened and enrolled patients per month will be registered to evaluate feasibility and acceptability.

  From start to end of recruitment (+/- 10 months)

• Drop-outs

  Total number of drop-outs will be registered to evaluate feasibility and acceptability.

  From start to end of recruitment (+/- 10 months)

• Reasons for withdrawal

  Reasons for withdrawal from the study will be registered to evaluate feasibility and acceptability

  From start to end of recruitment (+/- 10 months)

• Total and types of adverse events

  The total number and types of adverse events will be registered to evaluate feasibility and acceptability.

  From start to end of recruitment (+/- 10 months)

• Experienced issues during sessions

  Experienced issues during sessions will be registered to evaluate feasibility and acceptability

  During the 2-hour sessions (From start to end of recruitment [+/- 10 months])

• Evaluative questions

  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.

  At the end of the 2-hour intervention session (at post-intervention assessment)

• Patients qualitative first experiences

  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.

  At the end of the 2-hour intervention session, after the post-intervention assessment

Secondary Outcomes (5)

• 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)

Other Outcomes (14)

• Vividness of Visual Imagery Questionnaire (VVIQ)

  At the start of the single intervention session of 2 hours (pre-intervention assessment)

• Visualizer-Verbalizer Questionnaire (VVQ)

  At the start of the single intervention session of 2 hours (pre-intervention assessment)

• Schema Mode Inventory (SMI)

  Screening before start of intervention (+/- 1 week before)

Study Arms (1)

VR Schema Therapy Chairwork Exercise

OTHER

The intervention consists of a schema therapy chairwork exercise in Virtual Reality

Behavioral: VR Schema Therapy Chairwork Exercise

Interventions

VR Schema Therapy Chairwork Exercise BEHAVIORAL

VR Schema Therapy chairwork exercise

VR Schema Therapy Chairwork Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Elise C. D. van der Stouwe, PhD

CONTACT

+31 (0)6 39199758; e.c.d.van.der.stouwe@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Explorative, non-randomized pilot study with pre-post design (N=30)

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: January 28, 2026
• Study Start: February 14, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon publication of the manuscript
• Access Criteria: Data will be shared upon reasonable request after publication of the manuscript

Locations

NL (1)