Clinical Trials Logo

Clinical Trial Summary

Excessive and chronic stress is a major public global health concern. Young adults are at particular risk to experience heightened stress because of life transitions. Short skills-focused self-guided applications (SGA) on mobile phones are a cost-effective and scalable way to equip users with better stress-coping skills, but many SGA stress-coping programmes are not evidence-based, existing research is flawed with methodological problems and is also predominantly conducted in Western countries. Questions also remain for whom SGAs work (moderators) and by which pathways (mediators). This study is a randomised-controlled trial (RCT) that evaluates the effectiveness of a recently developed mobile-phone SGA in improving stress coping in young adults. Hypothesis 1: The intervention group will report significantly lower stress symptoms at post-intervention and 1-month follow-up compared to the control group. Hypothesis 2: Coping self-efficacy will mediate the expected relationship between the use of the Stress-SGA and lower stress symptoms, i.e. people with higher coping self-efficacy will benefit more from the Stress-SGA than those with lower coping self-efficacy. Hypothesis 3: Psychological mindedness will moderate the expected relationship between the use of Stress-SGA and lower stress symptoms, i.e. people high in psychological mindedness will benefit more from the Stress-SGA than those with lower psychological mindedness.


Clinical Trial Description

Procedure: Participants will sign up for the study via a survey link posted on the university's recruitment sites, where they will first read through the Participant Information Sheet, which contains information about the study such as study aims, methods, benefits and risks, the confidentiality of data, and contact information of the investigators. If participants agree to participate, they will provide their consent on the online consent form. Thereafter, they will proceed to complete a series of self-report measures on an online survey platform (baseline ratings). The online survey consists of the primary outcome measures on stress (PSM-9, PHQ-9 & GAD7), secondary outcome measures on coping self-efficacy and psychological mindedness (CSES & PM), and demographic information (age, gender). Next, participants will be randomly assigned to either the intervention or active control condition and guided to download the SGA on their personal mobile devices from the Apple App Store or Google Play Store. A number code will be provided to them to unlock the app according to their assigned condition. The SGA is developed by Intellect Pte Ltd, a Singapore based technology firm that collaborates with the supervisor of the study. Participants in the intervention condition will take part in the 8-day stress management program while those in the active control condition will take part in the 8-day cooperation learning program. Both programs will involve content education and short daily activities, averaging about five minutes, to fulfil a series of tasks aimed at improving their wellbeing. Daily reminders to complete the program will be sent via text messages by the researcher to participants. All participants will be instructed to refrain from engaging in any self-guided wellbeing apps other than the given SGA during the duration of the study, lasting from the beginning until the end of the 1-month follow-up. This minimises potential confounding effects. Upon completion of the 8-day program, participants will receive a survey link to complete the same questionnaires and in addition, will fill out the App Engagement Scale. One month upon completion of the SGA, participants will be emailed the survey link to the self-report measures again, along with the debrief and an information sheet explaining the main purposes of the study. All participants will be given a link to access the complete version of the SGA, providing them with access to all the wellbeing programs available for their personal use. Participants will be reimbursed with either course credit or a small monetary fee for their time and effort.. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04978896
Study type Interventional
Source National University, Singapore
Contact
Status Completed
Phase N/A
Start date September 1, 2021
Completion date February 1, 2022

See also
  Status Clinical Trial Phase
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Recruiting NCT04038190 - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course Phase 2
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Active, not recruiting NCT05998161 - Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout N/A
Completed NCT03728062 - Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT06405789 - The Effect of Yoga on Mindfulness and Perceived Stress N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Completed NCT05245409 - Stress, EEG, ECG, and Chiropractic N/A
Completed NCT04722367 - Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT06057883 - Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females Phase 2
Completed NCT05312749 - The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students N/A
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Completed NCT05623826 - Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager N/A
Completed NCT04013451 - The Kiss of Kindness Study II N/A