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

NCT04978896 | Completed

• 1 other identifier: NUS-IRB-2021-242
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in depressive symptoms

  Baseline, 8 days (completion of intervention), 4 weeks (follow-up)

• Change in generalised anxiety

  Baseline, 8 days (completion of intervention), 4 weeks (follow-up)

• Change in coping self-efficacy

  Baseline, 8 days (completion of intervention), 4 weeks (follow-up)

• Psychological mindedness

  Baseline

Other Outcomes (1)

• Engagement with the mobile application

  8 days (completion of intervention)

Study Arms (2)

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.

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.

Device: Self-guided program on cooperation

Interventions

Self-guided program on stress coping DEVICE

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.

Intervention group: Stress-coping Program

Self-guided program on cooperation DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-30
• Good command of the English Language

You may not qualify if:

• None

Sponsors & Collaborators

• National University of Singapore: lead
• Intellect Pte. Ltd.: collaborator

Study Sites (1)

National University of Singapore

Singapore, Singapore

Location

Related Publications (6)

• 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.

  PMID: 29154165 BACKGROUND

• Chesney 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.

  PMID: 16870053 BACKGROUND

• Conte 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.

  PMID: 2225801 BACKGROUND

• Spitzer 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.

  PMID: 16717171 BACKGROUND

• Kroenke 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.

  PMID: 11556941 BACKGROUND

• Toh 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.

  PMID: 36515984 DERIVED

Study Officials

• Oliver Suendermann, Ph.D.

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director Master in Clinical Psychology Program

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 27, 2021
• Study Start: September 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)