Virtual Reality Schema Therapy Exercises With Parent and Child Modes
ConditionPsychiatric Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Medical Center Groningen
About this trial
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. Are dialogue exercises with virtual reality mode avatars feasible, acceptable and useful? 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. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
VR Schema Therapy Chairwork Exercise
BehavioralVR Schema Therapy chairwork exercise
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: VR Schema Therapy Chairwork ExerciseOther 1 intervention
Trial outcomes
Primary outcomes
1
Screened and enrolled patients per month
The amount of screened and enrolled patients per month will be registered to evaluate feasibility and acceptability.
Time frame
From start to end of recruitment (+/- 10 months)2
Drop-outs
Total number of drop-outs will be registered to evaluate feasibility and acceptability.
Time frame
From start to end of recruitment (+/- 10 months)3
Reasons for withdrawal
Reasons for withdrawal from the study will be registered to evaluate feasibility and acceptability
Time frame
From start to end of recruitment (+/- 10 months)4
Total and types of adverse events
The total number and types of adverse events will be registered to evaluate feasibility and acceptability.
Time frame
From start to end of recruitment (+/- 10 months)Secondary outcomes
1
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.
Time frame
At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention)2
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 \[min. 0, max. 600\]).
Time frame
At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention)3
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.
Time frame
At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention)4
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.
Time frame
At the end of the 2-hour intervention session (at post-intervention assessment)Other outcomes
1
Vividness of Visual Imagery Questionnaire (VVIQ)
The Vividness of Visual Imagery Questionnaire (VVIQ) consists of 16 items assessing mental imagery ability. Each question is scored on a Likert scale ranging from 1 to 5, where higher scores represent lower ability of mental imagery. For purposes of interpretation, the scale is recoded in the current study, so that higher scores represent a higher ability of mental imagery.
Time frame
At the start of the single intervention session of 2 hours (pre-intervention assessment)2
Visualizer-Verbalizer Questionnaire (VVQ)
The Visualizer-Verbalizer Questionnaire (VVQ) consists of 30 items used in this study to assess mental imagery ability. The 30 items are divided over 3 subscales (10 items per subscale), namely visual, verbal, and dream items. These items measure a preference for either a visual or verbal learning style, and vividness of dreams. A more visual learning style and higher vividness of dreams is associated with mental imagery ability. Each question is scored on a binary scale choosing whether a statement is true or false for them. Total scores for each subscale are calculated (min. 0, max. 10), to assess the participants preference for either a visual or verbal learning style, and vividness of dreams. Higher scores represent a higher preference for a learning style or higher vividness of dreams.
Time frame
At the start of the single intervention session of 2 hours (pre-intervention assessment)3
Schema Mode Inventory (SMI)
The Schema Mode Inventory (SMI) will be used to screen participants for participation in the study. The SMI consists of 118 items assessing levels of presence of 14 schema modes. Questions are scored on a Likert scale ranging from 1 (never or almost never) to 6 (always). Mean scores are calculated for each schema mode (min. 1, max. 6). A score of \>3 on one of three schema modes (demanding parent, punitive parent, and/or vulnerable child) is used as a cut-off for inclusion in the study. Higher levels on the schema modes represent a higher level of presence of the schema mode.
Time frame
Screening before start of intervention (+/- 1 week before)4
Young Schema Questionnaire - Short Form version 3 (YSQ-SF)
The Young Schema Questionnaire - Short Form version 3 (YSQ-SF) will be used to assess schemas (core self-beliefs). The YSQ-SF consists of 90 statements (assessing 18 schemas, 5 questions each) which participants rate to what extent the statement is true for them (Likert scale 1 to 6). Mean scores are calculated for each schema (min. 1, max. 6). Higher scores represent a stronger presence of a schema.
Time frame
At the start of the single intervention session of 2 hours (at pre-intervention; baseline)Sponsors and contacts
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Source ClinicalTrials.gov