scholarly journals Feasibility, Effectiveness, and Mechanisms of a Brief Mindfulness- and Compassion-Based Program to Reduce Stress in University Students: A Pilot Randomized Controlled Trial

2021 ◽  
Vol 19 (1) ◽  
pp. 154
Author(s):  
David Martínez-Rubio ◽  
Jaime Navarrete ◽  
Jesus Montero-Marin
Keyword(s):  
Mental Health ◽  
Psychological Distress ◽  
University Students ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Wait List ◽  
Mindfulness Skills ◽  
Randomized Controlled ◽  
Self Compassion ◽  
Pilot Randomized Controlled Trial

The mental health of university students is a public health concern, as psychopathology has significantly risen among this population. Mindfulness-based programs may support their mental health, though more research is needed. We used a two-armed pilot randomized controlled trial to study the feasibility, preliminary effectiveness, and potential mechanisms of a brief 6-week instructor-led mindfulness- and compassion-based program (MCBP for University Life) on perceived stress and psychological distress. Thirty undergraduate psychology students participated (15 in the intervention group, and 15 as wait-list controls). Those in the intervention arm engaged well with the course and formal at-home practice, attending at least five sessions and meditating between 4–6 days per week. Significant improvements in perceived stress, psychological distress, mindfulness skills, decentering, self-compassion, and experiential avoidance were found at the end of the intervention, while the wait-list group remained unchanged. There were significant differences between the two groups in those variables at post-test, favoring the intervention arm with major effects. Reductions in stress were mediated by improvements in mindfulness skills, decentering, and self-compassion; meanwhile reductions in psychological distress were mediated by improvements in decentering. These results suggest that this intervention might be feasible and effective for university students, but more high-quality research is needed.

scholarly journals Efficacy and moderation of mobile application-based mindfulness-based training, self-compassion training, and cognitive-behavioral psychoeducation on mental health: A randomized controlled trial (Preprint)

2017 ◽  
Author(s):  
Winnie Wing Sze Mak ◽  
Alan Chun Yat Tong ◽  
Sindy Ying Chi Yip ◽  
Wacy Wai Sze Lui ◽  
Floria Hin Ngan Chio ◽  
...  
Keyword(s):  
Mental Health ◽  
Psychological Distress ◽  
Mobile Applications ◽  
Mobile Application ◽  
Controlled Trial ◽  
Well Being ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Self Compassion

BACKGROUND Mindfulness-based interventions, self-compassion training, and cognitive behavioral therapy have garnered much evidence in its salutary effects on mental health. With increasing application of smartphone and mobile technology on health promotion, the present study investigated the efficacy and possible moderators of mindfulness, self-compassion, and cognitive behavioral psychoeducation training mobile applications in the improvement of mental health. OBJECTIVE Our aim was to examine the efficacy of three mobile application-based programs: mindfulness-based program (MBP), self-compassion program (SCP), and cognitive behavioral psychoeducation control (CBP) in improving well-being and reducing psychological distress. To further delineate the suitability of each program for which type of individuals, individual difference variables (i.e., nonattachment, self-criticism, discomfort with emotion, and tolerance for ambiguity) were explored for potential moderation. METHODS The present study was a three-arm randomized controlled trial examining the efficacy of MBP, SCP with CBP. The course contents of the three programs were composed by a clinical psychologist and the mobile application was fully automated. Participants were recruited online and offline via mass mail, advertisements in newspapers and magazines, and social networking site. They were randomized into either one of the three conditions and completed pre-program survey assessment. Throughout the 4-week, 28-session program, participants spent 10 minutes daily in reviewing the course content and practicing various related exercises. Post-assessment and 3-month follow-up surveys were administered to measure changes over time. Indicators of mental health and psychological distress, as well as proposed moderators were self-assessed online at pre-program, post-program, and 3-month follow-up. RESULTS Among the 2,161 study participants, 508 and 349 completed the post- and 3-month follow-up assessment respectively. All three conditions (MBP, N = 703; CBP, N = 753; SCP, N = 705) were found to be efficacious in improving mental well-being and reducing psychological distress. No significant differences regarding usage and users’ satisfaction were found among the three conditions. None of the proposed moderators were found to be significant. CONCLUSIONS Mindfulness-based, self-compassion, and cognitive behavioral psychoeducation mobile applications were efficacious in improving mental health and reducing psychological distress among young adults at post-program, and such improvements were maintained at 3-month follow-up. Future app-based psychological training programs should consider gamification and personalization of content or feedback to enhance engagement and mitigate the high attrition rate that are common in app-based health promotion programs. CLINICALTRIAL Chinese Clinical Trial Registry (ChiCTR) ChiCTR-TRC-13003468; https://www2.ccrb.cuhk.edu.hk/registry/public/217 (Archived by WebCite at http://www.webcitation.org/6oaPwga7z).

scholarly journals The Web-Based Uprise Program for Mental Health in Australian University Students: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Karra D Harrington ◽  
Robert Eres ◽  
Michelle H Lim
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Web Based ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support. OBJECTIVE The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students. METHODS This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program. RESULTS The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes. CONCLUSIONS The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/21307

scholarly journals The Web-Based Uprise Program for Mental Health in Australian University Students: Protocol for a Pilot Randomized Controlled Trial

10.2196/21307 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e21307
Author(s):  
Karra D Harrington ◽  
Robert Eres ◽  
Michelle H Lim
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Web Based ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support. Objective The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students. Methods This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program. Results The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes. Conclusions The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291 International Registered Report Identifier (IRRID) DERR1-10.2196/21307

scholarly journals Effectiveness of providing university students with a mindfulness-based intervention to increase resilience to stress: 1-year follow-up of a pragmatic randomised controlled trial

2020 ◽  
pp. jech-2020-214390
Author(s):  
Julieta Galante ◽  
Jan Stochl ◽  
Géraldine Dufour ◽  
Maris Vainre ◽  
Adam Peter Wagner ◽  
...  
Keyword(s):  
Mental Health ◽  
Psychological Distress ◽  
Randomised Controlled Trial ◽  
University Students ◽  
Controlled Trial ◽  
Well Being ◽  
Workload Management ◽  
Mindfulness Skills ◽  
Randomised Controlled

BackgroundThere is concern that increasing demand for student mental health services reflects deteriorating student well-being. We designed a pragmatic, parallel, single-blinded randomised controlled trial hypothesising that providing mindfulness courses to university students would promote their resilience to stress up to a year later. Here we present 1-year follow-up outcomes.MethodsUniversity of Cambridge students without severe mental illness or crisis were randomised (1:1, remote software-generated random numbers), to join an 8-week mindfulness course adapted for university students (Mindfulness Skills for Students (MSS)), or to mental health support as usual (SAU).ResultsWe randomised 616 students; 53% completed the 1-year follow-up questionnaire. Self-reported psychological distress and mental well-being improved in the MSS arm for up to 1 year compared to SAU (p<0.001). Effects were smaller than during the examination period. No significant differences between arms were detected in the use of University Counselling Service and other support resources, but there was a trend for MSS participants having milder needs. There were no differences in students’ workload management; MSS participants made more donations. Home practice had positive dose–response effects; few participants meditated. No adverse effects related to self-harm, suicidality or harm to others were detected.ConclusionLoss to follow-up is a limitation, but evidence suggests beneficial effects on students’ average psychological distress that last for at least a year. Effects are on average larger at stressful times, consistent with the hypothesis that this type of mindfulness training increases resilience to stress.Trial registration numberACTRN12615001160527.

scholarly journals A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial

10.2196/30339 ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. e30339
Author(s):  
Pattie P Gonsalves ◽  
Rhea Sharma ◽  
Eleanor Hodgson ◽  
Bhargav Bhat ◽  
Abhijeet Jambhale ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Secondary School ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Sample Size Calculation ◽  
Health Intervention ◽  
Mental Health Intervention ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background “POD Adventures” is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions. Objective Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. Methods We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization. Results The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. Conclusions This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. Trial Registration ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486 International Registered Report Identifier (IRRID) DERR1-10.2196/30339

Effect of psychoeducation website named “Imacoco-care” on improving psychological distress among workers under COVID-19 pandemic: a randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Kotaro Imamura ◽  
Natsu Sasaki ◽  
Yuki Sekiya ◽  
Kazuhiro Watanabe ◽  
Asuka Sakuraya ◽  
...  
Keyword(s):  
Mental Health ◽  
Adverse Effect ◽  
Psychological Distress ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychoeducational Intervention ◽  
Favorable Effect ◽  
Randomized Controlled ◽  
Small Effect Size

BACKGROUND The prolonged coronavirus disease 2019 (COVID-19) pandemic affected mental health among workers. Psychoeducational intervention via an Internet website could be effective for primary prevention of mental health among workers in the current COVID-19 pandemic. OBJECTIVE The aim of this randomized controlled trial (RCT) was to examine the effect of a newly developed online psychoeducational website named "Imacoco-care" on reducing psychological distress and fear about COVID-19 infection among workers. METHODS Participants in the present study were recruited from registered members of a web survey company in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to intervention or control groups. Participants in the intervention group were invited to access the Imacoco-care within a month after the baseline survey. Kessler’s Psychological Distress Scale (K6) and The Fear of COVID-19 Scale (FCV-19S) were obtained at baseline, 1-, and 3-month follow-ups. RESULTS A total of 1200 workers were randomly allocated to an intervention or control group (n = 600 for each). In the intention-to-treat (ITT) analyses, the Imacoco-care showed significant favorable effect on K6 (p = 0.03) with small effect size (d = -0.14), and adverse effect on FCV-19S (p = 0.01) with small effect size (d = 0.16) in the intervention group at 3-month follow-up. In the per-protocol analyses (only included participants who have read the Imacoco-care at least one time), the Imacoco-care also showed significant favorable effect on reducing K6 (p = 0.03), while adverse effect on FCV-19S was not significant (p = 0.06) in the intervention group at 3-month follow-up. CONCLUSIONS A web-based psychoeducation approach may be effective on improving psychological distress in a general working population, while it may be important not only distributing information but also encouraging to access and see the contents to prevent the adverse effect of psychoeducational intervention. CLINICALTRIAL The University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The registration number is UMIN000042556 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048548).

Work-directed rehabilitation or physical activity to support work ability and mental health in common mental disorders: a pilot randomized controlled trial

2019 ◽  
Vol 34 (2) ◽  
pp. 170-181 ◽  
Author(s):  
Louise Danielsson ◽  
Margda Waern ◽  
Gunnel Hensing ◽  
Kristina Holmgren
Keyword(s):  
Mental Health ◽  
Physical Activity ◽  
Mental Disorders ◽  
Work Ability ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Work Ability Index ◽  
Randomized Controlled ◽  
Ability Index ◽  
Pilot Randomized Controlled Trial

Objective: To evaluate feasibility and potential effectiveness of work-directed rehabilitation in people with common mental disorders. Design: Pilot randomized controlled trial. Setting: Primary healthcare, Sweden. Subjects: Working adults ( n = 42) of mean age 46.2 ± 11.1 years with depression or anxiety disorder. Interventions: Eight weeks of work-directed rehabilitation ( n = 21) or physical activity ( n = 21). Work-directed rehabilitation included sessions with a physiotherapist and/or an occupational therapist, to develop strategies to cope better at work. Physical activity included a planning session and access to a local gym. Main measures: Feasibility: attendance, discontinuation and adverse events. Measurements were the Work Ability Index, the Global Assessment of Functioning, the Montgomery–Asberg Depression Rating Scale, the Beck Anxiety Inventory and the World Health Organization—Five Well-Being Index. Results: Attendance to rehabilitation sessions was 88% ( n = 147/167) and discontinuation rate was 14% ( n = 3/21). No serious adverse events were reported. Within both groups, there was a significant improvement in Work Ability Index score (mean change: 3.6 (95% confidence interval (CI): 0.45, 6.7) in work-directed rehabilitation and 3.9 (95% CI: 0.9, 7.0) in physical activity) with no significant difference between groups. For the other outcomes, significant improvements were found within but not between groups. Per-protocol analysis showed a trend toward the antidepressant effect of work-directed rehabilitation compared to physical activity (mean difference in depression score −3.1 (95% CI: −6.8, 0.4), P = 0.075). Conclusion: Work-directed rehabilitation was feasible to persons with common mental disorders and improved their work ability and mental health. Comparable improvements were seen in the physical activity group. Suggested modifications for a larger trial include adding a treatment-as-usual control.

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