Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000816853
Ethics application status
Approved
Date submitted
16/05/2021
Date registered
28/06/2021
Date last updated
18/01/2023
Date data sharing statement initially provided
28/06/2021
Date results information initially provided
18/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of a smartphone-delivered wellbeing program on psychological stress.
Scientific title
A pragmatic randomized pretest-posttest-follow up active controlled trial evaluating the effect of a mindfulness-based and cognitive behaviour therapy-based electronic health app on psychological stress in adults experiencing at least moderate psychological stress.
Secondary ID [1] 299866 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological Stress 320907 0
Condition category
Condition code
Mental Health 318724 318724 0 0
Anxiety
Mental Health 318725 318725 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319846 0
Prevention
Comparator / control treatment
Arm 3: Daily Scheduling in Evernote

Evernote is smartphone application with free and paid features and is available on both iOS and Android platforms. Evernote is designed for note taking, organizing work, and archiving information. This is achieved by creating notes that contain text and/or picture content which can be organized within digital notebooks using a tagging system. Unlike Smiling Mind and MoodMission, Evernote is not an electronic mental health app.

Participants randomized to the Evernote active-control group will be provided information that describes the mental health benefits of having a daily routine. The information that participants receive will be designed specifically for this study, and will draw on content provided in the following resources:

https://www.psychologytoday.com/au/blog/the-gen-y-psy/201810/the-power-routines-in-your-mental-health
https://www.psychologytoday.com/au/blog/living-the-questions/201808/6-reasons-why-you-should-use-daily-planner
https://www.webmd.com/mental-health/psychological-benefits-of-routine
https://www.verywellmind.com/the-importance-of-keeping-a-routine-during-stressful-times-4802638

Participants will also be given links to these resources as further reading. For this comparator treatment group, participants will be asked to use Evernote for 10 minutes per day writing notes on how they plan to organize their upcoming day, to describe the events of their previous day, and to identify whether there were any deviations to their plans the previous day. While the recommendation will be 10 minutes of use per day, 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 or less than 10 minutes, so long as they attempt to use the app daily.

Following four weeks of use of the Evernote 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. There will be no objective measurements of app use for the Evernote treatment group.
Control group
Active

Outcomes
Primary outcome [1] 326669 0
Psychological stress: Perceived Stress Scale (PSS-10)
Timepoint [1] 326669 0
Posttest (4 weeks post-commencement of intervention)
Secondary outcome [1] 392320 0
Psychological stress: Perceived Stress Scale (PSS-10)
Timepoint [1] 392320 0
Follow-up (8 weeks post-commencement of intervention)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed and performed by a third party not involved in recruitment and enrolment of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be generated using the blockrand package in R statistical software (v. 3.6.1; R Core Team). A 1:1:1 ratio using random block sizes of 3 and 6 will be implemented.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary Outcome Measure

- Psychological Stress measured using the Perceived Stress Scale (PSS-10).

Main Research Questions

- Research Question 1: Do the groups differ in psychological stress on the posttest?
- Research Question 2: Do the groups differ in psychological stress on the follow-up?
- Research Question 3: Are the group differences in stress the same at the posttest and the follow-up?
- Research Question 4: Do the groups differ in psychological stress on the average of the posttest and follow-up?

Hypotheses for Each Research Question

- Research Question 1

1. Individuals allocated to MoodMission will report lower psychological stress compared to those allocated to use the Evernote control app at posttest.
2. Individuals allocated to Smiling Mind will report lower psychological stress compared to those allocated to use the Evernote control app at posttest.

- Research Question 2

1. Individuals allocated to MoodMission will report lower psychological stress compared to those allocated to use the Evernote control app at follow-up.
2. Individuals allocated to Smiling Mind will report lower psychological stress compared to those allocated to use the Evernote control app at follow-up.

- Research Question 3

1. The group differences in psychological stress for MoodMisison compared to the Evernote control app will not be the same at the posttest and the follow-up
2. The group differences in psychological stress for Smiling Mind compared to the Evernote control app will not be the same at the posttest and the follow-up

- Research Question 4

1. Individuals allocated to MoodMission will report lower psychological stress compared to those allocated to use the Evernote control app at the average of the posttest and follow-up.
2. Individuals allocated to Smiling Mind will report lower psychological stress compared to those allocated to use the Evernote control app at the average of the posttest and follow-up.

Statistical Analysis of Primary Outcome Measure

- Hypotheses pertaining to Research Question 1

Each hypothesis will be analyzed using ANCOVA on the posttest scores with the pretest scores as the covariate. The omnibus effect for the ANCOVA is not relevant to the hypotheses of this research question and will not be reported. The primary analysis of interest is two pairwise contrasts: (1) MoodMission vs. Evernote, and (2) Smiling Mind vs. Evernote. An alpha level of .05 will be used for each contrast.

- Hypotheses pertaining to Research Question 2

Each hypothesis will be analyzed using ANCOVA on the follow-up scores with the pretest scores as the covariate. The omnibus effect for the ANCOVA is not relevant to the hypotheses of this research question and will not be reported. The primary analysis of interest is two pairwise contrasts: (1) MoodMission vs. Evernote, and (2) Smiling Mind vs. Evernote. An alpha level of .05 will be used for each contrast.

- Hypotheses pertaining to Research Question 3

Each hypothesis will be analyzed using ANCOVA on the follow-up minus posttest difference scores with the pretest scores as the covariate. The omnibus effect for the ANCOVA is not relevant to the hypotheses of this research question and will not be reported. The primary analysis of interest is two pairwise contrasts: (1) MoodMission vs. Evernote, and (2) Smiling Mind vs. Evernote. An alpha level of .05 will be used for each contrast.

- Hypotheses pertaining to Research Question 3

Each hypothesis will be analyzed using ANCOVA on the average of the posttest and follow-up scores with the pretest scores as the covariate. The omnibus effect for the ANCOVA is not relevant to the hypotheses of this research question and will not be reported. The primary analysis of interest is two pairwise contrasts: (1) MoodMission vs. Evernote, and (2) Smiling Mind vs. Evernote. An alpha level of .05 will be used for each contrast.

- Non-significant effects
Non-significant contrasts will be probed using an equivalence test with d = -0.50 and +0.50 as the equivalence bounds. An alpha level of .05 will be used for each test.

Target Sample Size:
N = 150 (n = 50 per group across three groups).

Sample Size Rationale:
The following parameters were used to determine the target sample size:

- Parameter 1: Target Effect Size

The minimally important difference with respect to health-related quality of life questionnaires often falls close to a standardized mean difference (hereby d) of 0.50 standard deviations (Norman et al., 2003). Therefore, this study will be designed to detect differences in means of a magnitude of d = 0.50.

- Parameter 2: Estimate of the correlation between (1) pre-test and post-test scores, and (2) pre-test and follow-up scores.

The sample size required for the proposed analyses (i.e., pairwise contrasts in an ANCOVA model) can be obtained through a power analysis for a simple independent groups t test and multiplying the result by a variance deflation factor of 1 – rho^2 (Borm et al., 2007). Rho represents the correlation between the (1) pre-test and post-test scores and (2) pre-test and follow-up scores, respectively. A previous study conducted by the current principal investigator
(anzctr.org.au identifier: ACTRN12621000610831) found that the correlation between pre-test scores and postest scores on the PSS-10 scale following a four week mindfulness intervention was r = 0.64, 95% CI [0.52, 0.74]. The lower limit of a two-tailed 60% CI on this correlation will be used as our estimate of rho in the variance deflation factor formula (see Perugini et al., 2014, for details on ‘safeguard effect sizes’). This yields an estimate of rho = 0.59 for this power analysis.

- Parameter 3: Alpha level

No alpha adjustment will be performed for the analysis of our primary variable (i.e., Smiling Mind vs. Evernote and MoodMission vs. Evernote) as this is not recommended for multi arm trials of distinct treatments (Parkeer and Weir, 2020). It is also not recommended to adjust alpha for having conducted the same analysis at posttest and follow-up, as these address distinct research questions and are considered separate hypothesis families. The alpha level for all analyses will therefore be alpha = .05.

- Parameter 4: Target power

We will target 80% power in this trial, which is a standard convention in psychological science.

Power Analysis Result

The following parameters were entered into a power analysis for an independent groups t test (pwr:pwr.t.test function in R) with the result multiplied by (1 – 0.59^2).

d = 0.50, alpha = .05 (two-sided), power = .80

This yields a required sample size of n = 126 participants (n = 42 per treatment group). To account for an approximate attrition rate of up to 20% we will aim to recruit an additional 25 participants for a total sample size of N = 150.

Power Analysis 2: Evaluation of non-significant findings

An equivalence test will be performed to follow-up a non-significant finding to determine if the mean difference is sufficiently small to be considered non-meaningful. This will involve two simultaneous one-sided t tests on pairs of means using the baseline score as a covariate.

- Parameter 1: Equivalence bounds

As described above, it has been shown that the minimally important difference with respect to health-related quality of life questionnaires falls consistently close to a standardized mean difference (hereby d) of 0.50 standard deviations (Norman et al., 2003). Therefore, in this study the equivalence bounds for a minimally important difference will be set at d = -0.50 and d = 0.50, such that the difference between two means will be considered equivalent if the standardized difference is simultaneously not less than -0.50 and not greater than 0.50.

- Parameter 2: Estimate of the pre-test covariate and post-test (and follow-up) outcome correlations

Once more, because the data collected in this trial will be analyzed using ANCOVA on the posttest (and follow-up) scores with the pretest score as a covariate, the sample size required for equivalence tests can be determined from a power analysis for two simultaneous one-sided independent groups t tests and then multiplying by a variance deflation factor of 1 – rho^2 (Borm et al., 2007). As above, our estimate of rho is 0.59.

- Parameter 3: Alpha level

Equivalence tests are usually assessed at the nominal alpha-level rather than as part of a hypothesis family because they are being used to follow-up non-significant findings. Therefore, no alpha adjustment is made for these analyses. Each equivalence test will be performed with an alpha level of .05.

- Parameter 4: Target power

We will target 80% power in this trial, which is a standard convention in psychological science.

Power Analysis Result

The following parameters were entered into a power analysis for two simultaneous one-sided t tests (i.e., an equivalence test) of two independent group means (TOSTER::powerTOSTtwo function in R) with the result multiplied by (1 – 0.59^2).

Equivalence Bounds = -0.50 and 0.50, alpha = .05, 1 – beta = .80

This yields a required sample size of n = 135 participants (n = 45 per treatment group). We will have sufficient power to perform equivalence tests using the total suggested sample size of 150.

Stopping Rule

Recruitment will proceed using a sequential (i.e., ‘trickle’) recruitment strategy across multiple recruitment waves until the target sample size of N = 150 is attained. (For example, this might include three waves of 50 participants that each start in different weeks or months). Because the analysis will comprise an intention-to-treat protocol all participants will be retained in the analyses regardless of dropout or non-adherence to protocol.

References

Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2003). Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation. Medical Care, 41(5), 582–592. https://doi.org/10.1097/01.MLR.0000062554.74615.4C

Borm, G. F., Fransen, J., & Lemmens, W. A. J. G. (2007). A simple sample size formula for analysis of covariance in randomized clinical trials. Journal of Clinical Epidemiology, 60(12), 1234–1238. https://doi.org/10.1016/j.jclinepi.2007.02.006

Perugini, M., Gallucci, M., & Costantini, G. (2014). Safeguard Power as a Protection Against Imprecise Power Estimates. Perspectives on Psychological Science, 9(3), 319–332. https://doi.org/10.1177/1745691614528519

Rausch, J. R., Maxwell, S. E., & Kelley, K. (2003). Analytic methods for questions pertaining to a randomized pretest, posttest, follow-up design. Journal of Clinical Child and Adolescent Psychology: The Official Journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53, 32(3), 467–486. https://doi.org/10.1207/S15374424JCCP3203_15

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/08/2021
Actual
19/09/2021
Date of last participant enrolment
Anticipated
Actual
24/01/2022
Date of last data collection
Anticipated
Actual
3/04/2022
Sample size
Target
150
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304327 0
University
Name [1] 304327 0
ISN Innovations
Country [1] 304327 0
Australia
Primary sponsor type
University
Name
ISN Innovations
Address
ISN Psychology
R15/443 Upper Heidelberg Rd, Ivanhoe,
Victoria, 3079
Australia
Country
Australia
Secondary sponsor category [1] 304573 0
None
Name [1] 304573 0
Address [1] 304573 0
Country [1] 304573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304779 0
ISN Psychology Human Research Ethics Committee (HREC)
Ethics committee address [1] 304779 0
ISN Psychology
R15/443 Upper Heidelberg Rd, Ivanhoe,
Victoria, 3079
Australia
Ethics committee country [1] 304779 0
Australia
Date submitted for ethics approval [1] 304779 0
16/02/2021
Approval date [1] 304779 0
25/05/2021
Ethics approval number [1] 304779 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98170 0
Dr Guy Prochilo
Address 98170 0
ISN Psychology
R15/443 Upper Heidelberg Rd, Ivanhoe,
Victoria, 3079
Australia
Country 98170 0
Australia
Phone 98170 0
+61 3 8900 0000
Fax 98170 0
Email 98170 0
gprochilo@isn.edu.au
Contact person for public queries
Name 98171 0
Dr Guy Prochilo
Address 98171 0
ISN Psychology
R15/443 Upper Heidelberg Rd, Ivanhoe,
Victoria, 3079
Australia
Country 98171 0
Australia
Phone 98171 0
+61 3 8900 0000
Fax 98171 0
Email 98171 0
gprochilo@isn.edu.au
Contact person for scientific queries
Name 98172 0
Dr Guy Prochilo
Address 98172 0
ISN Psychology
R15/443 Upper Heidelberg Rd, Ivanhoe,
Victoria, 3079
Australia
Country 98172 0
Australia
Phone 98172 0
+61 3 8900 0000
Fax 98172 0
Email 98172 0
gprochilo@isn.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified questionnaire responses and app usage data.
When will data be available (start and end dates)?
Upon completion of the trial and alongside submission of a scholarly manuscript on the study to a pre-print repository. Data will be available indefinitely (no end date).
Available to whom?
Publicly available on the Open Science Framework.
Available for what types of analyses?
No restrictions.
How or where can data be obtained?
The Open Science Framework: https://osf.io/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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