None listed
Conditions
Brief summary
Body dysmorphic disorder (BDD) is a disorder that is characterized by a significantly disturbed perception of one’s own appearance. We propose to conduct a randomised within-group mixed-methods study on individuals with BDD to determine the feasibility and acceptability of VR-based mindfulness training. This study will be conducted at Swinburne University of Technology, Melbourne, Australia. The feasibility and acceptability of VR-based mindfulness training will be achieved in a number of ways: 1) qualitative semi-structured interviews; 2) self-report measures; 3) physiological measures (i.e. heart rate variability and galvanic skin response). This comprehensive, multimodal assessment of these experiences will be integral in refining our mindfulness training for this complex disorder. The effects of receiving VR-based mindfulness training will be assessed through comparing pre- and post-intervention state mindfulness, body image concerns and emotional regulation variables.
Interventions
This is a randomized 2x2 crossover pilot clinical trial investigating brief VR and audio-based mindfulness. It will be conducted at Swinburne University (single site but state-wide recruitment), adhering to standardised guidelines (Consolidated Standards of Reporting Trials (CONSORT) and Standard Protocol Items Recommendations for Intervention Trials (SPIRIT) as well as Good Clinical Practice (GCP) guidelines. Participants will participate in both interventions, with the order of the interventio
This is a randomized 2x2 crossover pilot clinical trial investigating brief VR and audio-based mindfulness. It will be conducted at Swinburne University (single site but state-wide recruitment), adhering to standardised guidelines (Consolidated Standards of Reporting Trials (CONSORT) and Standard Protocol Items Recommendations for Intervention Trials (SPIRIT) as well as Good Clinical Practice (GCP) guidelines. Participants will participate in both interventions, with the order of the interventions being assigned randomly in a 1:1 ratio across the two arms – VR-audio and audio-VR. The randomisation sequence will be computer-generated by the student investigator. Outcome assessments will occur at baseline and post-interventions. VR-based mindfulness An Oculus Quest 2 (OQ2) Head-Mounted Display will be used with the following specifications: Adreno 650 (~1.2 TFLOPS) graphics on an LCD display with a resolution of 1,832 x 1,920 pixels per eye (2,560 x 1,440 combined), a refresh rate of 72-120 Hertz and a field of view of 101 degrees. The VR-based mindfulness program will be delivered by the application TRIPP. The program consists of a female voiceover using inviting language to guide the user’s shift in attention and focus and introduces the virtual environment. The VR-based mindfulness intervention component is fully contained within the VR headset and TRIPP application; there is no need for interaction with a researcher during the intervention process. The intervention will be delivered through the VR headset in person. 1 x 20minutes session The intervention will be delivered in clinical research space at Swinburne University of Technology Trained research staff members will sit with participants to perform well-being checks. Senior researcher will be contacted if any further support is required. Wash out period There will be a 'wash out' period of 20 minutes between the two treatments.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants will i) be aged between 18-65 years (inclusive); ii) have a primary diagnosis of BDD according to the SCID-5 BDD-DM (diagnostic module); iii) score greater than or equal to 15 on the BDD-YBOCS (to ensure at least mild symptom severity); iv) have been stabilised on psychiatric medications, if prescribed, for 8weeks; and v) have capacity to consent to the study. Further, BDD patients frequently report co-morbid depression, social anxiety and psychoses. To ensure our sample is representative, participants with co-morbidities will be included and may be engaged in current psychological or psychiatric treatment either for BDD or comorbid psychological symptoms.
Exclusion criteria
Participants will be excluded if i) uncorrected hearing and/or visual impairments are present; ii) they are unable to meaningfully converse in, or read, English; iii) previous or current significant head and neck injuries; iv) they have a history of sever psychopathology, substance dependence disorders, or psychotic disorders; vi) lifetime; v) have lifetime history of neurological or ocular conditions, vi) have an ongoing dialectical behaviour therapy and acceptance and commitment therapy, or therapy that actively includes mindfulness.
Outcome results
None listed