StressNCT04978896
Effectiveness of a Self-guided Mobile Application in Improving Wellbeing and Stress Coping
A study testing Self-guided program on stress coping and Self-guided program on cooperation in people with Stress, run by National University of Singapore at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Self-guided program on stress coping and Self-guided program on cooperation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Sep 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-30
- Good command of the English Language
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can a Self-guided Program on a Mobile Application Improve Wellbeing and Stress Coping? - A Randomized Controlled Trial
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.
Read more
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.
Read the detailed 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..
- Conditions
- Stress
- Being tested
- Self-guided program on stress coping, Self-guided program on cooperation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-guided program on stress copingDevice
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.
Self-guided program on cooperationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Stress-coping Program | Experimental | 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. Receives: Device: Self-guided program on stress coping |
| Control group | Active comparator | 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. Receives: Device: Self-guided program on cooperation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Sep 2021
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Intellect Pte. Ltd.
- Responsible party
- Principal investigator, Dr Oliver Suendermann, National University of Singapore
- Investigators
- Oliver Suendermann, Ph.D., Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978896
- Sponsor's protocol ID
- NUS-IRB-2021-242
- Status last verified
- Apr 2022
- First submitted
- 18 Jul 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bakker D, Rickard N. Engagement in mobile phone app for self-monitoring of emotional wellbeing predicts changes in mental health: MoodPrism. J Affect Disord. 2018 Feb;227:432-442. doi: 10.1016/j.jad.2017.11.016. Epub 2017 Nov 9.
PubMed 29154165Chesney MA, Neilands TB, Chambers DB, Taylor JM, Folkman S. A validity and reliability study of the coping self-efficacy scale. Br J Health Psychol. 2006 Sep;11(Pt 3):421-37. doi: 10.1348/135910705X53155.
PubMed 16870053Conte HR, Plutchik R, Jung BB, Picard S, Karasu TB, Lotterman A. Psychological mindedness as a predictor of psychotherapy outcome: a preliminary report. Compr Psychiatry. 1990 Sep-Oct;31(5):426-31. doi: 10.1016/0010-440x(90)90027-p.
PubMed 2225801Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Toh SHY, Tan JHY, Kosasih FR, Sundermann O. Efficacy of the Mental Health App Intellect to Reduce Stress: Randomized Controlled Trial With a 1-Month Follow-up. JMIR Form Res. 2022 Dec 14;6(12):e40723. doi: 10.2196/40723.
PubMed 36515984
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Self-guided Program on a Mobile Application Improve Wellbeing and Stress Coping? - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04978896
- Acronym / sponsor ID
- NUS-IRB-2021-242
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Intellect Pte. Ltd.
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Stress-coping Program | Experimental | Device: Self-guided program on stress copingParticipants 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. |
| Control group | Active comparator | Device: Self-guided program on cooperationParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-30
- Good command of the English Language
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-guided program on stress copingThis 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. | Device | Intervention group: Stress-coping Program |
| Self-guided program on cooperationThe 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. | Device | Control group |
Primary outcome
Change of psychological stress
Time frame: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
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.
4 secondary outcomes
Change in depressive symptoms
Time frame: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
Change in generalised anxiety
Time frame: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
Change in coping self-efficacy
Time frame: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)
Psychological mindedness
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Background: PubMed 29154165Bakker D, Rickard N. Engagement in mobile phone app for self-monitoring of emotional wellbeing predicts changes in mental health: MoodPrism. J Affect Disord. 2018 Feb;227:432-442. doi: 10.1016/j.jad.2017.11.016. Epub 2017 Nov 9.
- Background: PubMed 16870053Chesney MA, Neilands TB, Chambers DB, Taylor JM, Folkman S. A validity and reliability study of the coping self-efficacy scale. Br J Health Psychol. 2006 Sep;11(Pt 3):421-37. doi: 10.1348/135910705X53155.
- Background: PubMed 2225801Conte HR, Plutchik R, Jung BB, Picard S, Karasu TB, Lotterman A. Psychological mindedness as a predictor of psychotherapy outcome: a preliminary report. Compr Psychiatry. 1990 Sep-Oct;31(5):426-31. doi: 10.1016/0010-440x(90)90027-p.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Derived from this study: PubMed 36515984Toh SHY, Tan JHY, Kosasih FR, Sundermann O. Efficacy of the Mental Health App Intellect to Reduce Stress: Randomized Controlled Trial With a 1-Month Follow-up. JMIR Form Res. 2022 Dec 14;6(12):e40723. doi: 10.2196/40723.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Suendermann, Ph.D. principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-guided program on stress coping and Self-guided program on cooperation in people with Stress, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of psychological stress (time frame: Baseline, 8 days (completion of intervention), 4 weeks (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04978896, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.