Psychiatric DisordersVR-STEMNCT07373223
Virtual Reality Schema Therapy Exercises With Parent and Child Modes
A study testing VR Schema Therapy Chairwork Exercise in people with Psychiatric Disorders, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychiatric Disorders
- What is being tested?
- VR Schema Therapy Chairwork Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Feb 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Centre Groningen
Groningen, Provincie Groningen, 9713GZ
Elise C.D. van der Stouwe, PhD, +31 (0)6 39199758, e.c.d.van.der.stouwe@umcg.nl
About this study
Official title: VR-STEM: Virtual Reality Schema Therapy Exercises With Parent and Child Modes
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?
Read more
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.
- Conditions
- Psychiatric Disorders
- Being tested
- VR Schema Therapy Chairwork Exercise
- Keywords
- Virtual Reality Schema Therapy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Schema Therapy Chairwork ExerciseBehavioural
VR Schema Therapy chairwork exercise
| Study group | Role | What they receive |
|---|---|---|
| VR Schema Therapy Chairwork Exercise | Other | The intervention consists of a schema therapy chairwork exercise in Virtual Reality Receives: Behavioral: VR Schema Therapy Chairwork Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screened and enrolled patients per month
The amount of screened and enrolled patients per month will be registered to evaluate feasibility and acceptability.
Measured: From start to end of recruitment (+/- 10 months)
Drop-outs
Total number of drop-outs will be registered to evaluate feasibility and acceptability.
Measured: 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
Measured: 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.
Measured: From start to end of recruitment (+/- 10 months)
Experienced issues during sessions
Experienced issues during sessions will be registered to evaluate feasibility and acceptability
Measured: 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.
Measured: 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:
- How did you find the exercise?
- What did you find positive about the exercise? (how can we make the positive aspects even more positive?)
- 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.
Measured: At the end of the 2-hour intervention session, after the post-intervention assessment
Secondary outcomes (5)
Momentary Schema Modes Questionnaire (MSMQ)
The Momentary Schema Modes Questionnaire (MSMQ) will be completed by patients during the session. Difference scores will be used for evaluation of preliminary effects. The MSMQ consists of 35 questions measuring the present-moment level of 11 schema modes. The questions are rated on a Visual Analogue Scale ranging from 0-100 (total min. 0, max. 3500). Lower scores represent a lower presence of a certain schema mode.
Measured: At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention)
Visual Analogue Scales
Visual Analogue Scales will be used to measure affect and self-esteem. The questionnaire is derived from previous ESM studies, and consists of 12 questions divided over 3 subscales: positive affect (3 questions), negative affect (3 questions), self-esteem (6 questions). Each question is scored on a scale ranging from 0-100. Difference scores for each subscale are used to evaluate preliminary effects. Higher scores represent higher levels of the measured variable (positive affect [min. 0, max. 300], negative affect [min. 0, max. 300], self-esteem [min. 0, max. 600]).
Measured: 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)
The Self-Compassion and self-Criticism Scales (SCCS) is a questionnaire that measures levels of self-criticism and self-compassion. It consists of 5 situations, for which participants have to score to what extent they would respond to themselves in a reassuring, soothing, contemptuous, compassionate, critical, and harsh way. For the current study, each of the reactions is scored on a Visual Analogue Scale ranging from 0-100 (Self-criticism scale min. 0, max. 1500; self-compassion scale min. 0, max. 1500). Higher scores on the self-criticism scale represent higher levels of self-criticism, whereas higher scores on the self-compassion scale represent higher levels of self-compassion. Difference scores for each scale will be used to evaluate preliminary effects.
Measured: At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention)
Immersion
Two questions from the Igroup Presence Questionnaire (IPQ) will be used to assess immersion into Virtual Reality (VR). Both questions are scored on a Visual Analogue Scale ranging from 0-100 (total min. score 0, max. 200). Lower scores represent lower levels of immersion into the VR environment.
Measured: At the end of the 2-hour intervention session (at post-intervention assessment)
Therapeutic relationship
The Session Rating Scale (SRS) will be used to assess working alliance/therapeutic relationship. The SRS consists of 4 questions which are scored on a Visual Analogue Scale ranging from 0-100 (total min. 0, max. 400). Lower scores represent lower levels of experienced therapeutic relationship/working alliance during the intervention session.
Measured: At the end of the 2-hour intervention session (post-intervention asessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start14 Feb 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Explorative, non-randomized pilot study with pre-post design (N=30)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373223
- Sponsor's protocol ID
- 22811
- Acronym
- VR-STEM
- Status last verified
- Jan 2026
- First submitted
- 8 Sep 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request after publication of the manuscript
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR-STEM: Virtual Reality Schema Therapy Exercises With Parent and Child Modes
- ClinicalTrials.gov ID
- NCT07373223
- Acronym / sponsor ID
- VR-STEM / 22811
- Conditions
- Psychiatric Disorders
- Keywords
- Virtual Reality Schema Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 14 Feb 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Explorative, non-randomized pilot study with pre-post design (N=30)
| Arm | Type | Receives |
|---|---|---|
| VR Schema Therapy Chairwork Exercise | Other | Behavioral: VR Schema Therapy Chairwork ExerciseThe intervention consists of a schema therapy chairwork exercise in Virtual Reality |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR Schema Therapy Chairwork ExerciseVR Schema Therapy chairwork exercise | Behavioural | VR Schema Therapy Chairwork Exercise |
Primary outcome
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.
5 secondary outcomes
Momentary Schema Modes Questionnaire (MSMQ)
Time frame: At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention)
Visual Analogue Scales
Time frame: 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)
Time frame: At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention)
Immersion
Time frame: At the end of the 2-hour intervention session (at post-intervention assessment)
Therapeutic relationship
Time frame: At the end of the 2-hour intervention session (post-intervention asessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request after publication of the manuscript
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Schema Therapy Chairwork Exercise in people with Psychiatric Disorders, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise C. D. van der Stouwe, PhD (+31 (0)6 39199758, e.c.d.van.der.stouwe@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screened and enrolled patients per month (time frame: From start to end of recruitment (+/- 10 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.