|- candidate number||28192|
|- NTR Number||NTR6821|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-nov-2017|
|- Secondary IDs||ECSW2016-2208-412 ECSW2016-2208-412a|
|- Public Title||Take a DEEP breath: Testing the Effectiveness of a Virtual Reality Biofeedback Video Game for Anxiety Regulation |
|- Scientific Title||Take a DEEP breath: Testing the Effectiveness of a Virtual Reality Biofeedback Video Game for Anxiety Regulation |
|- hypothesis||This study will test the effectiveness of Virtual Reality Biofeedback Video Game DEEP in improving anxiety symptoms and related physiological arousal and appraisal patterns. It is expected that this game will lead to a greater improvement in these areas than a commercially available application that is focused on breath-based relaxation training. |
|- Healt Condition(s) or Problem(s) studied||Anxiety, Stress, Emotion regulation, Virtual Reality, Biofeedback|
|- Inclusion criteria||1. Individuals between the ages of 18 to 30 years old |
2. Elevated anxiety and stress symptoms on the DASS-21 screening questionnaire. This means that they score above the normal cut-off for anxiety (>8) and/or stress (>14).
3. Active consent from participants
|- Exclusion criteria||No active consent from participants |
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||3-nov-2017|
|- planned closingdate||1-jun-2018|
|- Target number of participants||200|
|- Interventions||1. Participants will be recruited through the SONA system of the Radboud University, an online recruitment system where individuals can sign up to participate in scientific studies. Once they have signed up they receive a link to the screening questionnaire. If they meet the criteria they are invited for further participation. |
2. Individuals are randomly assigned to the intervention or control condition. Individuals in the intervention condition will play DEEP, a Virtual Reality biofeedback video game that is controlled by diaphragmatic breathing. Individuals in the control group will use a commercially available (free) phone application (Paced Breathing) that guides individuals through a deep breathing exercise.
3. Both groups will first participate in 4 lab-sessions, distributed over 2-3 weeks, and a 3-month follow up. In all sessions they will be playing DEEP or using the breathing app for 10 minutes.
4. In the first session participants will have to do a performance task where they have to give an oral presentation to see how they respond to anxiety-provoking situations. Subsequently they will either be playing DEEP or they will be using the breathing app for 10 minutes.
5. In the second session, participants will again be playing either DEEP or they will be using the breathing app.
6. In the third session, participants will be either using the breathing app (control) or they will be playing DEEP, which will include an exposure element.
7. In the final session, participants will again be either using breathing app (control) or they will be playing DEEP, which will include an exposure element. Subsequently, they will again have to give an oral presentation.
8. After three months, participants will receive an e-mail asking them to fill out a follow-up questionnaire
|- Primary outcome||1. Pre-test (before 1st session), Post-test (after final session), and 3-month follow-up anxiety symptoms as measured by the Dutch version of the State-Trait Anxiety Inventory(STAI-DY; Van der Ploeg, Defares, & Spielberger, 1981)|
2. Patterns of self-reported state anxiety (STAI-DY) and physiological arousal (PAQ; Dieleman, Van der Einde, Verhulst, & Huizink, 2010) over the course of all the lab-sessions.
|- Secondary outcome||1. Changes in physiological measurements of heart-rate variability, breathing patterns and skin conductance over the course of all the lab-sessions. |
2. Changes in evaluations and appraisals e.g. engagement, self-efficacy, agency, and mindset over the course of all the lab-sessions.
3. Game/application evaluation: How much they liked it, what they liked about it (open-ended), what they did not like about it (open-ended), whether they would want to use it in the future and whether they would recommend it to someone else.
|- Timepoints||1. Screening (max 2 weeks before first session)|
2. Pre-test (before first session): demographics, anxiety symptoms
3. Throughout all intervention sessions: self-reported state anxiety, physiological arousal, appraisals and physiological measures.
4. Post-test (after final session): anxiety symptoms, game/application evaluation
5. 3-month follow up: anxiety symptoms
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Joanneke Weerdmeester|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Isabela Granic|
|- Sponsor/Initiator ||Radboud University Nijmegen, Behavioural Science Institute|
(Source(s) of Monetary or Material Support)
|NWO Creatieve Industrie (314-99-115), Stimuleringsfonds|
|- Brief summary||This study will test the effectiveness of Virtual Reality Biofeedback Video Game DEEP in improving anxiety symptoms and related physiological arousal and appraisal patterns. Individuals with elevated anxiety symptoms will be randomly assigned to play DEEP or a commercially available (free) phone application that guides individuals through a deep breathing exercise. Both applications will be used in 4 separate sessions over the course of 2-3 weeks. Anxiety symptoms will be assessed before the first session, after the final session and at a 3-month follow-up. Measurements of secondary outcomes such as changes in physiological arousal and appraisal patterns will be measured throughout all sessions. |
|- Main changes (audit trail)|
|- RECORD||13-nov-2017 - 1-dec-2017|