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ID
Source
Brief title
Health condition
n.a.: apparently healthy individuals will be enrolled.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mental health, measures by the Mental Health Continuum questionnaire.
Secondary outcome
Measures of psychological distress (PSS-10, PHQ-9, GAD-7, PANAS, ERQ, FFMQ)
Sleep quality (PISQ)
Physical health (self-reported symptoms and health care use).
Background summary
Smartphones are increasingly used to promote physical and mental wellbeing. Numerous downloadable applications (“apps”) have been developed to improve physical and mental wellbeing utilizing mobile devices (mHealth) and these apps can be accessed via most smart phone operating systems. The potential of these apps to produce positive changes in either physical or mental wellbeing remains insufficiently understood. The primary goal of this project is to evaluate: (a) whether apps targeting psychological factors produce improvements in mental wellbeing; and (b) whether individual characteristics prior to the use of these apps predict app effectiveness in improving mental wellbeing. A pre-post repeated measures design will be used in which four publicly available and “free” (no-payment) apps are compared and a fifth group will comprise of a no-app control condition. Participants will use the app for 2 weeks and will provide self-report data at baseline (prior to randomization), and at 1, 2 and 4 weeks follow-up.
Study objective
Research Question 1: Do mental health apps improve mental wellbeing? This question will be investigated by testing the following hypothesis: There will be an interaction between condition (allocation to one of the 4 apps vs. no-app control; between-subjects factor) and time (pre- and post-app use assessments of the Mental Health Continuum questionnaire (MHC; within-subjects factor). Data will be analyzed using analysis of variance (general linear model) using a 5 x 2 mixed model design. Data will be analyzed using an intention-to-treat approach with carry-forward of missing values.
Ancillary Research Questons: Additional analyses will be conducted examining: (a) the nature of the mental health apps (i.e., whether or not users are encouraged to engage in specific behaviors or whether only self-monitoring is involved); (b) which psychological measures might function as explanatory variables for changes in MHC scores; (c) which app-related characteristics (e.g., user-friendlyness) play a role in the effectiveness of the app; and (d) other health outcomes (e.g., physical activity, sleep quality, and physical health status & symptoms).
Study design
Baseline (pre-randomization), 1, 2 and 4 weeks follow-up.
Intervention
Four open access, no-cost (free), publicly available apps will be compared with a no-app control condition and also among themselves (see hypothesis for details). After the initial assessments, participants will be randomized to one of the 4 apps or the control condition, and they will use the app for 2 weeks. The four 'active' apps focus on: daily monitoring of emotions, meditation, mindfulness, and keeping a gratitude diary.
The project was reviewed and approved by the Ethics Review Board (ERB) of the Tilburg School of Social and Behavioral Sciences (project #: RP110) and does not require full METC review. The project was reviewed and approved for compliance with GDPR regulations.
Inclusion criteria
(1) age > 18 years; (2) access to a smartphone; (3) sufficient understanding of the English language (i.e., US 8th grade reading level or equivalent: the informed consent document and all apps will be in English); and (4) not a student in this particular research project (all other students are eligible); and (5) providing informed consent.
Exclusion criteria
There are no a priori exclusion criteria.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL8471 |
Other | Tilburg University : RP110 |