Effectiveness of a Self-guided Mobile Application in Improving Wellbeing and Stress Coping

Study Overview
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Brief Summary
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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.

Detailed Description
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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..

Official Title
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Can a Self-guided Program on a Mobile Application Improve Wellbeing and Stress Coping? - A Randomized Controlled Trial

Conditions
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Stress

Intervention / Treatment
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* Device: Self-guided program on stress coping
* Device: Self-guided program on cooperation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-30 Good command of the English Language Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group: Stress-coping Program<br>Participants will complete an 8-day self-guided programme on stress-coping delivered via a mobile-phone application with daily exercises guided by cognitive-behavioural principles. | Device: Self-guided program on stress coping<br>* This is an 8-day program that provides psychoeducation on the negative effects of stress and effective stress-management skills to combat stress. Guided by principles of CBT, the program targets the thoughts and behaviours of participants and equips them with skills to alter negative cognitions pertaining to stress. Participants are engaging with a series of exercises involving reflection and mindfulness where they are required to spot and write down their stressors, the negative thoughts associated with the stressors, as well as positive affirmations. Participants will also be taught breathing exercises and are encouraged to practice them during 2 check-ins.<br>|
| Active Comparator: Control group<br>Participants will complete an 8-day self-guided programme on cooperation delivered via a mobile-phone application with daily exercises that differ to the intervention group in terms of content but are comparable in terms of duration. | Device: Self-guided program on cooperation<br>* The 8-day program on cooperation aims to provide psychoeducation for participants to understand and improve collaboration and interpersonal relationships. Short quizzes and practice exercises on feedback-giving will be included. The time and duration of the cooperation SGA is matched to the stress-coping SGA to ensure that participants spend a similar amount of time and effort across both the intervention and active-control conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of psychological stress | Psychological Stress Measure (PSM-9; Lemyre & Tessier, 1988) is used to measure the affective, cognitive, behavioural, and somatic components of psychological stress. This is a 9-item self-report measure utilising a 8-point scale (1 = 'Not at all', 8 = 'Extremely'). Some examples of the items include I feel calm and I feel a great weight on my shoulders. Low ratings on items 1 and 6 and high ratings on the other items demonstrate greater symptomatology. When calculating for the total score, the opposite value of the rating will be given to items 1 and 6, where a rating of 1 = 8 points and conversely, a rating of 8 = 1 point. This results in higher total scores reflecting more stress symptoms. The PSM-9 is found to have excellent internal consistency where Cronbach׳s α = .89. | Baseline, 8 days (completion of intervention), 4 weeks (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms | The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) is a widely-used 9-item measure of depression symptoms. Stress symptoms often include low mood and depression, rendering the measuring of depression symptoms to be valid in identifying stress levels. Items include Feeling down, depressed, or hopeless and Poor appetite or overeating. Items are scored on a 4-point scale (0 ='Not at all'; 3 = 'Nearly every day'). It has been found to have an excellent internal consistency of Cronbach's α=0.89. | Baseline, 8 days (completion of intervention), 4 weeks (follow-up) | 
| Change in generalised anxiety | Generalised Anxiety Disorder scale (GAD-7; Spitzer et al., 2006) is a 7-item self-report instrument used to measure symptoms of generalised anxiety in the past 2 weeks. Similar to depression, anxiety and low mood are recognised as stress symptoms. Hence, measuring anxiety symptoms will aid with identifying stress levels. Examples of the item are Worrying too much about different things and Trouble relaxing. The same response scale as PHQ-9 is used, where higher scores reflect more symptoms. Similar to the PHQ-9, the internal reliability of GAD-7 is excellent with Cronbach's α = .92. | Baseline, 8 days (completion of intervention), 4 weeks (follow-up) | 
| Change in coping self-efficacy | Coping Self-Efficacy Scale (CSES; Chesney et al., 2006) is a 26-item self-report instrument used to measure perceived self-efficacy for coping with threats and challenges. The items include Keep from feeling sad and Resist the impulse to act hastily when under pressure. A 11-point scale is used (0 = 'Cannot do at all'; 5 = 'Moderately certain can do'; 10 = 'Certain can do'). A higher score denotes greater belief in one's coping abilities. The CSE possesses an excellent internal consistency of Cronbach's α= 0.95. | Baseline, 8 days (completion of intervention), 4 weeks (follow-up) | 
| Psychological mindedness | Psychological Mindedness Scale (PM; Conte et al., 1990) measures an individual's ability to reflect on psychological processes, emotional processing and interpersonal relationships. PM is a 45-item self-report instrument consisting of items such as I often find myself thinking about what made me act in a certain way and I am sensitive to the changes in my own feelings. It utilises a 4-point scale to score items (4 = 'Strongly agree'; 1 = 'Strongly disagree'). Higher total scores indicate higher levels of psychological mindedness. The PM produced a good internal consistency of Cronbach's α= 0.86. | Baseline |