Psychiatric Disorders
Conditions
Keywords
Virtual Reality Schema Therapy
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. 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.
Interventions
BEHAVIORALVR Schema Therapy Chairwork Exercise
VR Schema Therapy chairwork exercise
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Explorative, non-randomized pilot study with pre-post design (N=30)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screened and enrolled patients per month | 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 | From start to end of recruitment (+/- 10 months) | Total number of drop-outs will be registered to evaluate feasibility and acceptability. |
| Reasons for withdrawal | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Momentary Schema Modes Questionnaire (MSMQ) | At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention) | 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. |
| Visual Analogue Scales | At the start (baseline) and at the end of the single session of 2 hours (pre- and post-intervention) | 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 \[min. 0, max. 600\]). |
| 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) | 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. |
| Immersion | At the end of the 2-hour intervention session (at post-intervention assessment) | 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. |
| Therapeutic relationship | At the end of the 2-hour intervention session (post-intervention asessment) | 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. |
Countries
Netherlands
Contacts
CONTACTElise C. D. van der Stouwe, PhD
Outcome results
None listed