None listed
Conditions
Brief summary
The aim of this study is to assess the effectives of a mindfulness-based and CBT-based mental health app on psychological stress in a sample of stressed (but otherwise healthy) individuals against an active control. The overall rationale for this study is to determine whether these apps can be used as a primary (prevention-focused) intervention for individuals who are are potentially at risk of developing a clinically significant psychological problem.
Interventions
Arm 1: Smiling Mind App
Smiling Mind is a free evidence-based electronic health smartphone application developed by a team of psychologists and is available on iOS and Android platforms. It contains hundreds of hours of guided and unguided mindfulness meditation instructions that target different demographics (e.g., adults, kids, and the classroom) and which have been designed to address different mental health needs (e.g., sleep, stress management, and relationships). The programs in Smiling M
Arm 1: Smiling Mind App Smiling Mind is a free evidence-based electronic health smartphone application developed by a team of psychologists and is available on iOS and Android platforms. It contains hundreds of hours of guided and unguided mindfulness meditation instructions that target different demographics (e.g., adults, kids, and the classroom) and which have been designed to address different mental health needs (e.g., sleep, stress management, and relationships). The programs in Smiling Mind are informed by theories and practices that draw on both contemplative traditions and evidence-based science, and the central therapeutic approach is based on sustained mindfulness meditation practice. Participants randomized into the Smiling Mind treatment group will be provided with instructions to download the application to their smartphone and will be asked to use any meditations available within “Adults” program. Participants will be recommended to use the app for 10 min per day for the duration of the study in line with recommendations from the developers of Smiling Mind. However, participants will be told that they are welcome to use the app in a manner that is suitable for their life needs and daily schedule, which may include sometimes using the app for more than 10 minutes (i.e., completing a 20 – 30 min meditation or multiple practices) or less than 10 minutes (e.g., completing a single 1 – 2-minute meditation or activity) so long as they attempt to use the app daily. Participants will be recommended to first complete “Mindfulness Foundations”, which contains 35 sessions covering formal mindfulness instruction (e.g., the body scan and mindfulness of breath) and informal mindfulness instruction (e.g., incorporating mindfulness practices into daily life) that form the framework of most mindfulness-based interventions. Following four weeks of use of the Smiling Mind app, participants will be instructed that they can use the app for the next four weeks in any manner they deem suitable. This may include continued use of the app, increasing or decreasing frequency of use, or discontinuation of use of the app altogether. Being a pragmatic trial, there is no adherence criteria. Objective measurements of app use (duration and frequency of use) will be obtained from the Smiling Mind research team and reported in the subsequent manuscript. Arm 2: MoodMission App MoodMission is also a free evidence-based electronic health smartphone application developed by a team of psychologists and is available on iOS and Android platforms. It recommends cognitive behavior therapy strategies in response to user-reported low moods and anxious feelings. When participants open MoodMission they are asked to input their current emotional distress and MoodMission will provide a tailored list of five CBT-based strategies (called ‘missions’ within the app) that the participant can choose from to complete. Each mission comes with an objective for the participant to complete and an evidence-based explanation for why that objective will help alleviate emotional distress. Missions are designed to help individuals replace or change one’s relationship with maladaptive coping methods, skills, cognitive, emotions, and behavior with more adaptive ones. Consistent with modern CBT therapies, MoodMission also includes some mindfulness meditation missions as methods of addressing maladaptive thoughts. However, unlike Smiling Mind and mindfulness-based interventions more generally, the therapeutic approach is grounded in evidence-based practices drawn from cognitive behavior therapy and sustained mindfulness training is not part of this approach. Participants randomized into the MoodMission treatment group will be provided with instructions to download the application and to fill in their user information (this also includes entering a study-specific code in a relevant field). Because MoodMission is mission-based rather than based on sustained formal meditation practice, it is not appropriate to recommend participants to use MoodMission for a pre-specified time per day. Instead, participants will be asked to use the app and complete at least one MoodMission ‘mission’ per day (or more if desired) at a time of their choosing. Following four weeks of use of the MoodMission app, participants will be instructed that they can use the app for the next four weeks in any manner they deem suitable. This may include continued use of the app, increasing or decreasing frequency of use, or discontinuation of use of the app altogether. Being a pragmatic trial, there is no adherence criteria. Objective measurements of app use (duration and frequency of use) will be obtained from the MoodMission research team and reported in the subsequent manuscript.
Sponsors
ISN Innovations
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Score at least 14 on the Perceived Stress Scale (PSS-10; Cohen & Williamson, 1988) which is indicative of ‘moderate stress’. 2. Have English as their first language or satisfy university-level English requirements (i.e., 80 on TOEFL or 6.5 on IELTS). 3. Consent to downloading an app to their smartphone and use that app for the duration of the trial. 4. Consent to being randomly allocated to a treatment group based on random allocation and understand that it is essential to remain part of that group for the duration of the study even if it is not their preferred group. 5. Consent to being contacted by researchers by email and mobile phone for the duration of the study. 6. Consent to being contacted if choosing to withdraw or end participation in the study in order to describe (briefly) the reasons for doing so (note: participants are not obliged to give a reason for withdrawing if they do not want to and can communicate this to the researchers involved). 7. Consent to app usage data being shared from app developers to the principal investigator of this study for the duration of the trial period, and understand that after the trial ends the data linking you to any app usage data will be destroyed by the app developers. 8. Consent to all responses provided in this study being stripped of all identifying information and deposited in a scientific public database (https://osf.io/) for independent verification of results and use of these data in future research for the betterment of human knowledge.
Exclusion criteria
1. Are currently suffering from severe periods of depression or anxiety. This might include feelings of sadness, hopelessness, excessive anxiety, or a loss of interest or pleasure in normal activities occurring nearly every day for more than two months and which impairs normal daily functioning. This also includes a formal clinical diagnosis of a depressive or anxiety disorder. 2. Have a past or present incidence of any other serious mental or physical health issue that would impact one’s capacity to participate in this trial. This includes past or present psychotic disorders.
Outcome results
None listed