scholarly journals Efficacy of the Digital Therapeutic Mobile App BioBase to Reduce Stress and Improve Mental Well-Being Among University Students: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Sonia Ponzo ◽  
Davide Morelli ◽  
Jamie M Kawadler ◽  
Nicola Rose Hemmings ◽  
Geoffrey Bird ◽  
...  
Keyword(s):  
University Students ◽  
Controlled Trial ◽  
Well Being ◽  
Mobile App ◽  
Control Group ◽  
Full Time ◽  
Digital Version ◽  
Sustained Effects ◽  
Mental Well Being

BACKGROUND University students in the United Kingdom are experiencing increasing levels of anxiety. A program designed to increase awareness of one’s present levels of well-being and suggest personalized health behaviors may reduce anxiety and improve mental well-being in students. The efficacy of a digital version of such a program, providing biofeedback and therapeutic content based on personalized well-being metrics, is reported here. OBJECTIVE The aim of this study was to test the efficacy and sustained effects of using a mobile app (BioBase) and paired wearable device (BioBeam), compared with a waitlist control group, on anxiety and well-being in university students with elevated levels of anxiety and stress. METHODS The study employed a randomized, waitlist-controlled trial with assessments at baseline, 2 weeks, postintervention (4 weeks), and follow-up (6 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored &gt;14 points on the Depression, Anxiety, and Stress Scale-21 items (DASS-21) stress subscale or &gt;7 points on the DASS-21 anxiety subscale, (3) owned an iOS mobile phone, (4) did not have any previous psychiatric or neurological conditions, (6) were not pregnant at the time of testing, and (7) were able to read and understand English. Participants were encouraged to use BioBase daily and complete at least one course of therapeutic content. A <i>P</i> value ≤.05 was considered statistically significant. RESULTS We found that a 4-week intervention with the BioBase program significantly reduced anxiety and increased perceived well-being, with sustained effects at a 2-week follow-up. Furthermore, a significant reduction in depression levels was found following the 4-week usage of BioBase. CONCLUSIONS This study shows the efficacy of a biofeedback digital intervention in reducing self-reported anxiety and increasing perceived well-being in UK university students. Results suggest that digital mental health interventions could constitute a novel approach to treat stress and anxiety in students, which could be combined or integrated with existing therapeutic pathways. CLINICALTRIAL Open Science Framework (OSF.io) 2zd45; https://osf.io/2zd45/

scholarly journals Efficacy of the Digital Therapeutic Mobile App BioBase to Reduce Stress and Improve Mental Well-Being Among University Students: Randomized Controlled Trial

10.2196/17767 ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. e17767 ◽  
Author(s):  
Sonia Ponzo ◽  
Davide Morelli ◽  
Jamie M Kawadler ◽  
Nicola Rose Hemmings ◽  
Geoffrey Bird ◽  
...  
Keyword(s):  
University Students ◽  
Controlled Trial ◽  
Well Being ◽  
Mobile App ◽  
Control Group ◽  
Full Time ◽  
Digital Version ◽  
Sustained Effects ◽  
Mental Well Being

Background University students in the United Kingdom are experiencing increasing levels of anxiety. A program designed to increase awareness of one’s present levels of well-being and suggest personalized health behaviors may reduce anxiety and improve mental well-being in students. The efficacy of a digital version of such a program, providing biofeedback and therapeutic content based on personalized well-being metrics, is reported here. Objective The aim of this study was to test the efficacy and sustained effects of using a mobile app (BioBase) and paired wearable device (BioBeam), compared with a waitlist control group, on anxiety and well-being in university students with elevated levels of anxiety and stress. Methods The study employed a randomized, waitlist-controlled trial with assessments at baseline, 2 weeks, postintervention (4 weeks), and follow-up (6 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored >14 points on the Depression, Anxiety, and Stress Scale-21 items (DASS-21) stress subscale or >7 points on the DASS-21 anxiety subscale, (3) owned an iOS mobile phone, (4) did not have any previous psychiatric or neurological conditions, (6) were not pregnant at the time of testing, and (7) were able to read and understand English. Participants were encouraged to use BioBase daily and complete at least one course of therapeutic content. A P value ≤.05 was considered statistically significant. Results We found that a 4-week intervention with the BioBase program significantly reduced anxiety and increased perceived well-being, with sustained effects at a 2-week follow-up. Furthermore, a significant reduction in depression levels was found following the 4-week usage of BioBase. Conclusions This study shows the efficacy of a biofeedback digital intervention in reducing self-reported anxiety and increasing perceived well-being in UK university students. Results suggest that digital mental health interventions could constitute a novel approach to treat stress and anxiety in students, which could be combined or integrated with existing therapeutic pathways. Trial Registration Open Science Framework (OSF.io) 2zd45; https://osf.io/2zd45/

Efficacy of a Smartphone App Intervention for Reducing Caregiver Stress: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Matthew Fuller-Tyszkiewicz ◽  
Ben Richardson ◽  
Keriann Little ◽  
Samantha Teague ◽  
Linda Hartley-Clark ◽  
...  
Keyword(s):  
Active Control ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Self Esteem ◽  
Mobile App ◽  
Control Group ◽  
Self Monitoring

BACKGROUND Caregivers play a pivotal role in maintaining an economically viable health care system, yet they are characterized by low levels of psychological well-being and consistently report unmet needs for psychological support. Mobile app–based (mobile health [mHealth]) interventions present a novel approach to both reducing stress and improving well-being. OBJECTIVE This study aims to evaluate the effectiveness of a self-guided mobile app–based psychological intervention for people providing care to family or friends with a physical or mental disability. METHODS In a randomized, single-blind, controlled trial, 183 caregivers recruited through the web were randomly allocated to either an intervention (n=73) or active control (n=110) condition. The intervention app contained treatment modules combining daily self-monitoring with third-wave (mindfulness-based) cognitive-behavioral therapies, whereas the active control app contained only self-monitoring features. Both programs were completed over a 5-week period. It was hypothesized that intervention app exposure would be associated with decreases in depression, anxiety, and stress, and increases in well-being, self-esteem, optimism, primary and secondary control, and social support. Outcomes were assessed at baseline, postintervention, and 3-4 months postintervention. App quality was also assessed. RESULTS In total, 25% (18/73) of the intervention participants were lost to follow-up at 3 months, and 30.9% (34/110) of the participants from the wait-list control group dropped out before the postintervention survey. The intervention group experienced reductions in stress (<i>b</i>=−2.07; <i>P</i>=.04) and depressive symptoms (<i>b</i>=−1.36; <i>P</i>=.05) from baseline to postintervention. These changes were further enhanced from postintervention to follow-up, with the intervention group continuing to report lower levels of depression (<i>b</i>=−1.82; <i>P</i>=.03) and higher levels of emotional well-being (<i>b</i>=6.13; <i>P</i>&lt;.001), optimism (<i>b</i>=0.78; <i>P</i>=.007), self-esteem (<i>b</i>=−0.84; <i>P</i>=.005), support from family (<i>b</i>=2.15; <i>P</i>=.001), support from significant others (<i>b</i>=2.66; <i>P</i>&lt;.001), and subjective well-being (<i>b</i>=4.82; <i>P</i>&lt;.001). On average, participants completed 2.5 (SD 1.05) out of 5 treatment modules. The overall quality of the app was also rated highly, with a mean score of 3.94 out of a maximum score of 5 (SD 0.58). CONCLUSIONS This study demonstrates that mHealth psychological interventions are an effective treatment option for caregivers experiencing high levels of stress. Recommendations for improving mHealth interventions for caregivers include offering flexibility and customization in the treatment design. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12616000996460; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371170

scholarly journals Efficacy of a Smartphone App Intervention for Reducing Caregiver Stress: Randomized Controlled Trial

10.2196/17541 ◽  
2020 ◽  
Vol 7 (7) ◽  
pp. e17541
Author(s):  
Matthew Fuller-Tyszkiewicz ◽  
Ben Richardson ◽  
Keriann Little ◽  
Samantha Teague ◽  
Linda Hartley-Clark ◽  
...  
Keyword(s):  
Active Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Self Esteem ◽  
Mobile App ◽  
Trial Registration ◽  
Control Group ◽  
Self Monitoring

Background Caregivers play a pivotal role in maintaining an economically viable health care system, yet they are characterized by low levels of psychological well-being and consistently report unmet needs for psychological support. Mobile app–based (mobile health [mHealth]) interventions present a novel approach to both reducing stress and improving well-being. Objective This study aims to evaluate the effectiveness of a self-guided mobile app–based psychological intervention for people providing care to family or friends with a physical or mental disability. Methods In a randomized, single-blind, controlled trial, 183 caregivers recruited through the web were randomly allocated to either an intervention (n=73) or active control (n=110) condition. The intervention app contained treatment modules combining daily self-monitoring with third-wave (mindfulness-based) cognitive-behavioral therapies, whereas the active control app contained only self-monitoring features. Both programs were completed over a 5-week period. It was hypothesized that intervention app exposure would be associated with decreases in depression, anxiety, and stress, and increases in well-being, self-esteem, optimism, primary and secondary control, and social support. Outcomes were assessed at baseline, postintervention, and 3-4 months postintervention. App quality was also assessed. Results In total, 25% (18/73) of the intervention participants were lost to follow-up at 3 months, and 30.9% (34/110) of the participants from the wait-list control group dropped out before the postintervention survey. The intervention group experienced reductions in stress (b=−2.07; P=.04) and depressive symptoms (b=−1.36; P=.05) from baseline to postintervention. These changes were further enhanced from postintervention to follow-up, with the intervention group continuing to report lower levels of depression (b=−1.82; P=.03) and higher levels of emotional well-being (b=6.13; P<.001), optimism (b=0.78; P=.007), self-esteem (b=−0.84; P=.005), support from family (b=2.15; P=.001), support from significant others (b=2.66; P<.001), and subjective well-being (b=4.82; P<.001). On average, participants completed 2.5 (SD 1.05) out of 5 treatment modules. The overall quality of the app was also rated highly, with a mean score of 3.94 out of a maximum score of 5 (SD 0.58). Conclusions This study demonstrates that mHealth psychological interventions are an effective treatment option for caregivers experiencing high levels of stress. Recommendations for improving mHealth interventions for caregivers include offering flexibility and customization in the treatment design. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12616000996460; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371170

scholarly journals Effects of smartphone-based stress management on improving work engagement among nurses in Vietnam: a secondary analysis of a three-arm randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Natsu Sasaki ◽  
Kotaro Imamura ◽  
Thuy Thi Thu Tran ◽  
Huong Thanh Nguyen ◽  
Kazuto Kuribayashi ◽  
...  
Keyword(s):  
Stress Management ◽  
Work Engagement ◽  
Controlled Trial ◽  
Well Being ◽  
Management Program ◽  
Control Group ◽  
Full Time ◽  
Small Effect Size ◽  
Stress Management Program

BACKGROUND Work engagement is important for employee’s well-being and work performance. However, no intervention study has investigated the effect of eMental Health intervention on work engagement among workers in low- and middle-income countries (LMICs). OBJECTIVE The aim of the study was to examine the effects of the newly developed smartphone-based stress management program (“ABC stress management”) on improving work engagement among hospital nurses in Vietnam, a LMIC. METHODS Full-time nurses (N= 949) were randomly assigned to two types of intervention groups and a control group. A 6-week, 6-lesson program offering basic cognitive behavioral therapy (CBT-based stress management skills); provided in free-choice (Program A) and fixed order (Program B). Work engagement was assessed at baseline, 3- and 7-month follow-ups in each of the three groups. RESULTS Program B showed a significant intervention effect on improving work engagement at 3-month follow-up (p = 0.049) with a small effect size (Cohen’s d = 0.16). Neither program achieved effectiveness at a 7-month follow-up. CONCLUSIONS The study demonstrated that a smartphone-based stress management program was effective in improving work engagement in nurses in Vietnam, but the effect was small and temporary. This smartphone-based low-cost intervention may improve work engagement for workers in LMICs. CLINICALTRIAL UMIN Clinical Trials Registry (UMIN-CTR) UMIN000033139.

scholarly journals Gratitude as Mood Mediates the Effects of a 6-Weeks Gratitude Intervention on Mental Well-Being: Post hoc Analysis of a Randomized Controlled Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Ernst Bohlmeijer ◽  
Jannis Kraiss ◽  
Marijke Schotanus-Dijkstra ◽  
Peter ten Klooster
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Sensitivity Analyses ◽  
Control Group ◽  
Multiple Mediation ◽  
Randomized Controlled ◽  
Gratitude Intervention ◽  
Mental Well Being ◽  
Gratitude Interventions

There is a gap of knowledge about the extent to which gratitude is indeed the working mechanism of change in gratitude interventions aiming to promote mental well-being. This study explores the mediational role of gratitude as mood in the context of a recently conducted randomized controlled trial on the effects of a 6-week gratitude intervention on mental well-being in comparison with a waitlist control group. Gratitude as mood was measured at 2, 4, and 6 weeks. Both simple and multiple mediation models were conducted as well as various sensitivity analyses. Results showed a gradual increase of gratitude as mood during the intervention. The effects of the 6-week gratitude intervention on mental well-being were mediated by increases of gratitude as mood at 4 weeks but not at 2 weeks. These findings suggest a dose-response relationship for gratitude interventions, but more research is warranted.

scholarly journals Using Smartphone-Based Psychoeducation to Reduce Postnatal Depression Among First-Time Mothers: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Ko Ling Chan ◽  
Wing Cheong Leung ◽  
Agnes Tiwari ◽  
Ka Lun Or ◽  
Patrick Ip
Keyword(s):  
Randomized Controlled Trial ◽  
Postnatal Depression ◽  
Controlled Trial ◽  
Mobile App ◽  
Control Group ◽  
Randomized Controlled ◽  
First Time Mothers ◽  
Expectant Mothers ◽  
First Time

BACKGROUND Smartphone-based psychoeducation interventions may be a low-cost, user-friendly alternative to resource-consuming, face-to-face antenatal classes to educate expectant mothers. OBJECTIVE This study aimed to empirically examine whether such an intervention would lead to reduced postnatal depression, anxiety, or stress and result in a better health-related quality of life. METHODS A single-blind randomized controlled trial was conducted in Hong Kong. All first-time expectant mothers with less than 24 weeks of gestation remaining and attending the antenatal clinic at a public hospital were included. Participants were assigned to the intervention group or the control group by drawing lots. The lots, presented in sealed opaque envelopes, were randomly designated as “intervention” or “control” by stratified randomization. The intervention, a psychoeducational mobile app, was provided in addition to the treatment as usual (TAU) services from the hospital. Follow up with participants took place at 4 weeks postpartum. The primary outcome was the difference in the levels of antenatal and postnatal depression, assessed by the Edinburgh Postnatal Depression Scale (EPDS). The intention-to-treat approach was employed in the analyses. RESULTS The final sample was 660 expectant mothers (nintervention=330 and ncontrol=330). The mean difference in EPDS scores between the two groups was −0.65 (95% CI −1.29 to 0.00; P=.049) after adjusting for confounding factors. Associations were found between participation in the intervention and reduced depression, and attendance in TAU classes and increased stress levels. CONCLUSIONS The smartphone-based intervention plus TAU services was effective in reducing postnatal depression at 4 weeks postpartum compared with a control condition of TAU only, making this a cost-effective alternative to TAU education for expectant mothers. Limitations of the study included the short postpartum period after which the follow-up assessment was conducted and the inclusion of first-time mothers rather than all mothers. CLINICALTRIAL HKU Clinical Trials Registry HKUCTR-2024; http://www.hkuctr.com/Study/Show/ 34f62a2f6d594273a290491827206384

scholarly journals Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Marjolein M. Iversen ◽  
Jannicke Igland ◽  
Hilde Smith-Strøm ◽  
Truls Østbye ◽  
Grethe S. Tell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Foot Ulcer ◽  
Well Being ◽  
Foot Ulcers ◽  
Control Group ◽  
Patient Reported ◽  
Reported Health

Abstract Background Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care. Methods The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer–Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up. Results In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life. Conclusions There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants’ health, well-being and quality of life. Trial registration Clinicaltrials.gov, NCT01710774. Registered October 19th, 2012.

scholarly journals Resilience@Work Mindfulness Program: Results From a Cluster Randomized Controlled Trial With First Responders (Preprint)

2018 ◽  
Author(s):  
Sadhbh Joyce ◽  
Fiona Shand ◽  
Tara J Lal ◽  
Brendan Mott ◽  
Richard A Bryant ◽  
...  
Keyword(s):  
High Risk ◽  
Controlled Trial ◽  
Intervention Group ◽  
First Responders ◽  
Well Being ◽  
Control Group ◽  
Resilience Training ◽  
Cluster Randomized ◽  
Adaptive Resilience

BACKGROUND A growing body of research suggests that resilience training can play a pivotal role in creating mentally healthy workplaces, particularly with regard to protecting the long-term well-being of workers. Emerging research describes positive outcomes from various types of resilience training programs (RTPs) among different occupational groups. One specific group of workers that may benefit from this form of proactive resilience training is first responders. Given the nature of their work, first responders are frequently exposed to stressful circumstances and potentially traumatic events, which may impact their overall resilience and well-being over time. OBJECTIVE This study aimed to examine whether a mindfulness-based RTP (the Resilience@Work [RAW] Mindfulness Program) delivered via the internet can effectively enhance resilience among a group of high-risk workers. METHODS We conducted a cluster randomized controlled trial (RCT) comprising 24 Primary Fire and Rescue and Hazmat stations within New South Wales. Overall, 12 stations were assigned to the 6-session RAW Mindfulness Program and 12 stations were assigned to the control condition. A total of 143 active full-time firefighters enrolled in the study. Questionnaires were administered at baseline, immediately post training, and at 6-month follow-up. Measurements examined change in both adaptive and bounce-back resilience as well as several secondary outcomes examining resilience resources and acceptance and mindfulness skills. RESULTS Mixed-model repeated measures analysis found that the overall test of group-by-time interaction was significant (P=.008), with the intervention group increasing in adaptive resilience over time. However, no significant differences were found between the intervention group and the control group in terms of change in bounce-back resilience (P=.09). At 6-month follow-up, the group receiving the RAW intervention had an average increase in their resilience score of 1.3, equating to a moderate-to-large effect size compared with the control group of 0.73 (95% CI 0.38-1.06). Per-protocol analysis found that compared with the control group, the greatest improvements in adaptive resilience were observed among those who completed most of the RAW program, that is, 5 to 6 sessions (P=.002). CONCLUSIONS The results of this RCT suggest that mindfulness-based resilience training delivered in an internet format can create improvements in adaptive resilience and related resources among high-risk workers, such as first responders. Despite a number of limitations, the results of this study suggest that the RAW Mindfulness Program is an effective, scalable, and practical means of delivering online resilience training in high-risk workplace settings. To the best of our knowledge, this is the first time a mindfulness-based RTP delivered entirely via the internet has been tested in the workplace. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12615000574549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368296 (Archived by WebCite at http://www.webcitation.org/75w4xtrpw).

scholarly journals Practicing Other-Focused Kindness and Self-Focused Kindness Among Those at Risk for Mental Illness: Results of a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
S. Katherine Nelson-Coffey ◽  
Ernst T. Bohlmeijer ◽  
Marijke Schotanus-Dijkstra
Keyword(s):  
At Risk ◽  
Mental Illness ◽  
Psychological Distress ◽  
Controlled Trial ◽  
Well Being ◽  
Added Value ◽  
Waitlist Control ◽  
Dutch Sample ◽  
Mental Well Being

People with reduced levels of mental well-being might be at risk for developing future mental illness. Although several positive psychology interventions successfully improve mental well-being and psychological distress, less is known about their efficacy in a sample at risk for mental disorders. A Dutch sample of 289 participants with low or moderate levels of well-being were randomly assigned to other-focused kindness with reflection, other-focused kindness without reflection, self-focused kindness, or waitlist control (Trial register: NTR6786). Results of multilevel growth curve analyses revealed that other-focused kindness, but not self-focused kindness, led to improvements in the primary outcome mental well-being relative to waitlist control up to 6-week follow-up. By contrast, only other-focused kindness without reflection led to improvements in psychological distress. The three kindness conditions mainly did not differ from one another, and mainly no differences were found up to 6-months follow-up. An exception was that perceived stress was significantly more reduced up to 6-week and 6-months follow-up when people practiced other-focused kindness without reflection then when participants had practiced self-focused kindness. These findings point to the benefits of practicing kindness for others when people might be at risk for future mental illness. The study also indicates that reflecting about practicing kindness does not seem to have added value.

scholarly journals Efficacy of a mindfulness-based intervention programme with and without virtual reality support to reduce stress in university students: protocol for a randomized controlled pragmatic trial

2021 ◽  
Author(s):  
Marta Modrego-Alarcón ◽  
María Teresa Navarro-Gil ◽  
María Beltrán-Ruiz ◽  
Alicia Monreal-Bartolomé ◽  
Santiago Gascón ◽  
...  
Keyword(s):  
Virtual Reality ◽  
University Students ◽  
Perceived Stress ◽  
Well Being ◽  
Self Report ◽  
Control Group ◽  
Large Sample Size ◽  
Randomized Controlled ◽  
The Impact

Abstract Background: There is growing concern about mental health problems in university students. For this reason, mindfulness training is becoming increasingly popular in university settings. However, mindfulness-based interventions (MBIs) usually present high attrition rates. This trial aims to evaluate the efficacy of a MBI to reduce perceived stress and to improve the psychological well-being of university students, as well as to explore the capacity of virtual reality (VR) to enhance adherence to the intervention. Methods: This study protocol presents a randomized controlled trial (RCT) involving assessment time points of baseline, posttreatment and 6-month follow-up. A total of 280 students from the Spanish National Distance Education University (UNED) or the University of Zaragoza will be randomly assigned to a mindfulness condition, a mindfulness condition complemented by VR, and a relaxation condition to serve as a control group. Stress will be the main outcome and will be measured using the 10-item self-report Perceived Stress Scale (PSS). Other well-being and academic functioning outcomes will be assessed, as well as variables that explore the impact of VR. Multilevel mixed-effects models will be calculated to estimate the efficacy of the programme, and effect size estimations will be carried out. Effects of VR in adherence to programme will be evaluated. Discussion: Some strengths of this study are the RCT design, which includes a suitable active control group and a 6-month follow-up assessment; a large sample size of university students at different stages of their courses and a variety of degrees; and the incorporation of the VR support to facilitate completion of the MBI programme. Potential limitations are the voluntary participation of the students and the utilization of self-report measures.Trial registration number: ClinicalTrials.gov NCT03771300.

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