Stress management programme with virtual reality-based biofeedback

Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: The 4‐week intervention programme investigated in this study includes four training sessions of heart rate variability biofeedback in virtual reality conducted weekly in the laboratory, which are supplemented by brief daily at‐home exercises supported by a mobile application. The study also includes a wait‐list control group. Participants (50% male and 50% female) will be randomly assigned to either the intervention group or the wait‐list control group, which will both simultaneously undergo three assessments (pre‐assessment during week 1 of the intervention, post‐assessment in the week after the intervention and follow‐up‐assessment 4 weeks after the intervention). Randomisation takes place when participants sign up for their sessions. Experimenters have already pre‐assigned groups to a specific day and time. Participants will only be informed about their group assignment after they have signed up. Randomisation was achieved by hidden pre‐assigned groups (intervention or wail‐list control) for each session participants could sign up for. Specifically, participants were able to select one of ten possible first sessions (i.e. in the first week), without knowing the hidden pre‐assigned group of each sessions. Only after signing up for the study were the participants informed about the assigned group. CONDITION: Reduction of stress and stress‐related symptoms in healthy individuals ; Mental and Behavioural Disorders PRIMARY OUTCOME: 1. Levels of self‐reported stress are measured using the Perceived Stress Scale (PSS) and the subscale Stress of the Depression, Anxiety and Depression Scales (DASS) before the intervention (PRE) and one (POST) and four (FOLLOW‐UP) weeks after the intervention; 2. Heart rate at rest measured using a wearable chest belt (Polar H10) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW‐UP) weeks after the intervention.; 3. Systolic and diastolic blood pressure at rest measured using a blood pressure monitor (Omron HBP‐1120) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW‐UP) weeks after the intervention; 4. Heart rate variability features at rest measured using a wearable chest belt (Polar H10) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW‐UP) weeks after the intervention; 5. Levels of self‐reported psychological state using a Visual Analogue Scale (VAS) and the Multidimensional Mood Questionnaire (MDMQ) are measured before, during and after a psychosocial stress test one week after the intervention (POST); 6. Salivary cortisol and salivary alpha‐amylase measured using IBL‐Tecan SaliCaps® and heart rate and heart rate variability features measured using the wearable chest belt Polar H10 before, during and after a psychosocial stress test 1 week after the intervention (POST) INCLUSION CRITERIA: 1. Fluent in German 2. Have normal or corrected‐to‐normal vision 3. Exhibit no disability of arms or hands 4. Have obtained at least a secondary school diploma 5. 18‐40 years of age SECONDARY OUTCOME: 1. Levels of self‐reported anxiety are measured using the DASS before the intervention (PRE) and 1 (POST) and 4 (FOLLOW‐UP) weeks after the intervention; 2. Levels of self‐reported depression are measured using the DASS before the intervention (PRE) and 1 (POST) and 4 (FOLLOW‐UP) weeks after the intervention; 3. Levels of self‐reported mindfulness are measured using the Mindfulness Attention and Awareness Scale (MAAS) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW‐UP) weeks after the intervention; 4. Levels of self‐reported psychological well‐being are measured using the World Health Organisation‐Five Well‐Being Inde X(WHO‐5) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW‐UP) weeks after the intervention; 5. Levels of self‐reported health‐related quality of life are measured using the Short Form Health Survey (SF‐36) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW‐UP) weeks after the intervention; 6. Levels of self‐reported fatigue are measured using the Multidimensional Fatigue Inventory (MFI‐20) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW‐UP) weeks after the intervention; 7. Levels of self‐reported basic psychological needs satisfaction and frustration are measured using the Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW‐UP) weeks after the intervention
Epistemonikos ID: c1d6fb6b1d383913c79f3d18845967b75a31b866
First added on: Feb 20, 2024