Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000911897
Ethics application status
Approved
Date submitted
28/05/2021
Date registered
14/07/2021
Date last updated
4/07/2022
Date data sharing statement initially provided
14/07/2021
Date results provided
4/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of a psychological skills-training App on the wellbeing and burnout risk among medical students
Scientific title
Evaluating the effect of an online individualised psychological flexibility skills training program on burnout and wellbeing among medical students
Secondary ID [1] 304331 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burnout 322087 0
Psychological Wellbeing 322088 0
Condition category
Condition code
Mental Health 319803 319803 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 320112 320112 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME:
Acceptance and Commitment Training (ACT)
• Arm 1: ACT (individualised)
• Arm 2: ACT (non-individualised)
• Arm 3: Waiting list (to receive ACT – individualised after waiting period)

MATERIALS:
Online App (BiSi), available via Google Play Store and Apple App Store
Digital device to access App (e.g. iPhone or Android phone, iPad or tablet) – provided by participant.

PROCEDURES:
1. Context
Acceptance and Commitment Training (ACT) is based on the well-established psychological flexibility model. Psychological flexibility is a set of adaptive behavioural skills that are associated with wellbeing outcomes. The ACT intervention approach facilitates the development of individual psychological flexibility skills for non-clinical populations, promoting and facilitating actions that support individual wellbeing (Biglan, Hayes, & Pistorello, 2008; Frögéli, Djordjevic, Rudman, Livheim, & Gustavsson, 2016). Rather than defining uncomfortable internal experiences (e.g. thoughts, emotions, physical sensations) as “symptoms” that need to be changed or eliminated, ACT focuses on altering the way individuals relate to these internal experiences (Steven C. Hayes, Strosahl, & Wilson, 2012; Reeve, Tickle, & Moghaddam, 2018) and empowering them to respond in ways that are more adaptive in their own lives (Larmar, Wiatrowski, & Lewis-Driver, 2014). This is accomplished through activities that normalise challenging internal experiences, as well as training individuals to strengthen present-moment awareness, recognise the influence of their internal experiences over their actions, learn to alter unworkable responses to these internal experiences, and develop more flexible behavioural repertoires that are consistent with their personally chosen values (Steven C. Hayes et al., 2012; Larmar et al., 2014; Moran, 2010; Reeve et al., 2018).
ACT is conceptually well defined and clearly links its interventions to the mechanisms through which it purportedly elicits change: that is, the 6 Psychological Flexibility processes and their corresponding inflexibility processes (Stockton et al., 2019). The components of an ACT intervention include:
1) Present-Moment Awareness (Mindfulness)
2) Cognitive Defusion
3) Self-as-Context
4) Acceptance
5) Values
6) Committed Action

2. Methods
Stage 1: All participants will complete a brief introductory module that provides education about burnout and wellbeing, as well as introducing the core concepts for each of the skills trained within the ACT model.

Upon completion of Stage 1, participants will be randomised into one of the 3 treatment arms. Participants in Arms 1 and 2 will be given access to Stage 2 of the App.

Stage 2:
During Stage 2, Arm 1 and 2 participants may access the App at any time during the intervention period.
“Part 1: Learn the concepts” - Participants will complete a more in-depth educational module outlining each of the 6 ACT components listed above.
“Part 2: Learn the behaviours” - There are six modules, one for each of the ACT intervention components listed above. Each module consists of 20 experiential skill-building activities (duration 3-7 mins each) that train the corresponding ACT skill (n total = 120 activities). The inclusion of this number of activities was guided by previous studies indicating that 28 activities were too few (Levin, Haeger, Pierce, & Cruz, 2017) and 136 were sufficient (Levin, Haeger, & Cruz, 2019).

Each time participants access Part 2, they will complete a check-in assessment. This is a single-item question assessing which of the ACT skills they are having the most difficulty with in that moment.
• Arm 1 (ACT - Individualised): During Part 2, an Arm 1 participant’s check-in assessment rating at each login session will be used to individualise their intervention experience. Participants indicate which ACT skill they are having the most difficulty with at the time of each check-in, and are subsequently given access to the dashboard for the training module that corresponds with that skill (e.g. if a participant identifies that they are having the most difficulty attending to the present moment, they will be given access to the present-moment awareness module dashboard). The dashboard allows them to either choose one of the 20 skill activities within that module from a list, or request the App to select one of the activities at random. Once they have completed the activity, they have the option of completing another activity or exiting the App. Participants can complete this process as many times as they choose during the intervention period.
• Arm 2 (ACT - non-individualised): During Part 2, Arm 2 participants have access to the same intervention materials as those in Arm 1. The only difference between the modules is the method used to select which activity they receive each session. Participants complete the check-in assessment at the beginning of each login session. For this group, the outcomes of this assessment will not be used to select the activity the participant is presented with during that session. Instead, an activity from any of the 6 psychological flexibility modules (n activities = 120) will be presented at random. Upon completion of the random activity, participants will have the option of completing another activity, which will also be selected at random from the full activity pool. If they choose not to complete another activity, they can exit the App.

WHO WILL DELIVER THE INTERVENTION
The online intervention materials were developed and created by an experienced clinical psychologist, Elizabeth Ditton (19 years’ clinical experience, and 15 years’ experience and training in the intervention model). The intervention is based on established psychological theory, research, and methods.
A second clinical psychologist (Brendon Knott) with equivalent experience contributed to the development of the intervention content, and checked the overall intervention for fidelity to the ACT approach and psychological flexibility model.
Audio content within the App is delivered by Elizabeth Ditton.

MODE OF DELIVERY:
All intervention components will be delivered online via the BiSi App, and are presented in a combination of written and audio formats.

NUMBER OF TIMES:
Stage 1: Participants are required to complete the Stage 1 information session before randomisation to an intervention arm.
Stage 2: During Stage 2, participants will be required to complete “Part 1: Learn the concepts” before they are given access to “Part 2: Learn the behaviours”. They may subsequently revisit any element of “Part 1: Learn the concepts” if they choose to, via the App Dashboard.
During “Part 2: Learn the behaviours”, participants will be encouraged to practice at least 4 skill activities. Each participant will ultimately choose their own usage frequency. Engagement will be facilitated using daily App notification or email reminders and positive reinforcement pertaining to progress through the App.
For both stages, we will collect usage data so we can examine the impact of degree and frequency of intervention engagement on outcomes.

DURATION:
Stage 1: The introductory module will take approximately 10 mins to complete
Stage 2: Participants will have access to Stage 2 for 5 weeks.
- Part 1 (Learn the Concepts): This will take approximately 30-40 mins to complete, and can be completed either in one sitting, or multiple sittings within a 2-week period.
- Part 2 (Learn the Behaviours): Participants will have access to Part 2 for up to 5 weeks in total, depending on how quickly they complete Part 1 (e.g. participants who complete Part 1 on the first day will have the remaining 5 weeks to use Part 2, while participants who take the full 2 weeks to complete Part 1 will have the remaining 3 weeks to use Part 2). Participants will be asked to complete a minimum of 4 skill activities in Part 2.
Participants may use the App at their own chosen frequency.

LOCATION:
Due to the online and portable nature of the App, participants can engage in the intervention in any location suitable to them.
The App is available for free download onto Apple and Android devices. Use of the App will require a study access code, provided to participants after consent is obtained.

TAILORING:
As previously outlined, the Stage 2 intervention for Arm 1 participants will be individualised, such that they will receive targeted skill activities each time they use the App (compared with the random skill delivery method used for the Arm 2 version of Stage 2).
The current study will adopt a “treatment utility” methodology (Steven C. Hayes et al., 2019) that compares the individualised ACT program and the non-individualised ACT program. Using this methodology, we address individual heterogeneity with respect to psychological flexibility at the intervention level, allowing for the group-level comparison of outcomes between individualised and non-individualised intervention groups.
Intervention code [1] 320682 0
Prevention
Intervention code [2] 320683 0
Treatment: Other
Intervention code [3] 320684 0
Behaviour
Comparator / control treatment
Arm 3 (Waiting list): Upon completion of Stage 1, Arm 3 participants will wait for 5 weeks. Once they have completed T2 follow up questionnaires, they will be given access to the Arm 1 version of the App. This group receives the basic Stage 1 introductory module, but does not receive any further intervention during the following 5 weeks. We will compare treatment Arms 1 and 2 to Arm 3 to determine whether participants who completed the 5-week ACT App (Stage 2) achieved superior outcomes.

Arm 2 is also an active comparison group. Both Arms 1 and 2 deliver the same ACT intervention. The difference between the groups is the mode of delivery: individualised or non-individualised during Stage 2. By comparing Arm 1 (individualised) with Arm 2 (non-individualised), we aim to determine whether the individualised intervention produces additional benefits over a generic non-targeted intervention
Control group
Active

Outcomes
Primary outcome [1] 327666 0
Burnout:
Maslach Burnout Inventory – General Survey for Students (MBI – GS (S)) (Schaufeli, Martínez, Pinto, Salanova, & Bakker, 2002)
Timepoint [1] 327666 0
• T1: Pre-intervention
• T2: Post-intervention (5 weeks after randomisation into Stage 2)
Secondary outcome [1] 396187 0
Wellbeing:
Mental Health Continuum – Short Form (MHC-SF) (Keyes, 2005)
Timepoint [1] 396187 0
• T1: Pre-intervention
• T2: Post-intervention (5 weeks after randomisation into Stage 2)
Secondary outcome [2] 396189 0
Psychological Flexibility:
Multidimensional Psychological Flexibility Inventory (MPFI) – Short Form (J. L. Rolffs et al., 2018)
Timepoint [2] 396189 0
• T1: Pre-intervention
• T2: Post-intervention (5 weeks after randomisation into Stage 2)
Secondary outcome [3] 396190 0
Mental health:
Depression Anxiety and Stress Scale-21 (DASS-21) (Lovibond & Lovibond, 1995)
Timepoint [3] 396190 0
• T1: Pre-intervention
• T2: Post-intervention (5 weeks after randomisation into Stage 2)

Eligibility
Key inclusion criteria
- Enrolled in first, second, fourth, or fifth year undergraduate medicine at the University of Newcastle or University of New England
- Regular access to reliable wifi
- Regular access to an electronic device compatible with App utilisation (smartphone or tablet)
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic - Minimisation. In order to maintain the allocation ratio of 1:1:1 under conditions where we may not reach our target recruitment numbers, we will adopt an adaptive minimisation randomisation process (generated within the App) where each new participant's likelihood of allocation to a particular Arm will be influenced by the number of participants already allocated to each arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We conducted a power analysis to determine an appropriate sample size for repeated measures multivariate ANOVA (3 groups, 2 time points, high correlation between pre-and post measures (=0.6) and measuring 2 time points (baseline and post). The calculation allowed for a small effect size (0.25), given this is the most conservative approach but still clinically meaningful. For power = 80% and alpha = 0.05, the total required sample size is 117 (39 per intervention arm). We are allowing for an attrition rate of up to a 30%, which is a conservative assessment on the basis that Levin et al. (2019) observed a 15% attrition rate using a similar study design for an online psychological flexibility intervention. In order to allow for this attrition rate, our target sample size for recruitment is 153 participants (51 per intervention arm).

Analyses will be conducted using both intention-to-treat (ITT) and efficacy subset analysis. This approach is recommended for preventive interventions in order to address the risks of bias with both methods (Frögéli et al., 2016). ITT reduces the risk of Type I errors (i.e. sample skewed towards participants with positive outcomes). However, this method increases the risk of Type 2 errors (i.e. sample skewed by participants who did not complete the intervention). This is considered important in a preventive study, as there may be an increased possibility of early withdrawal from participants who do not consider burnout to be a problem for them. Efficacy subset analyses reduce the risk of Type II errors.
- We will assess between groups differences, as well as within group differences over time for each outcome (burnout, wellbeing, and psychological flexibility) using repeated measures ANOVA between groups (Hypotheses 1 to 4).
- We will assess whether psychological flexibility outcomes mediate burnout and wellbeing outcomes using regression analyses (Hypothesis 5).
- Descriptive analyses will be performed for usage data obtained from the intervention platform in order to assess engagement, including engagement frequency, recruitment, retention, and adherence rates.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/07/2021
Actual
20/08/2021
Date of last participant enrolment
Anticipated
30/09/2021
Actual
30/09/2021
Date of last data collection
Anticipated
5/11/2021
Actual
31/10/2021
Sample size
Target
153
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307841 0
University
Name [1] 307841 0
University of Newcastle
Country [1] 307841 0
Australia
Funding source category [2] 308705 0
University
Name [2] 308705 0
Centre for Rehab Innovations, University of Newcastle
Country [2] 308705 0
Australia
Funding source category [3] 308706 0
University
Name [3] 308706 0
Priority Research Centre for Stroke and Brain Injury, University of Newcastle
Country [3] 308706 0
Australia
Primary sponsor type
University
Name
University of Newcastle, Centre for Rehab Innovations
Address
University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 309594 0
None
Name [1] 309594 0
Address [1] 309594 0
Country [1] 309594 0
Other collaborator category [1] 281808 0
Individual
Name [1] 281808 0
Brendon Knott
Address [1] 281808 0
Contextual Interventions / Esteem Psychology
735 Hunter Street
Newcastle West NSW 2302
Country [1] 281808 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307840 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 307840 0
Ethics committee country [1] 307840 0
Australia
Date submitted for ethics approval [1] 307840 0
27/11/2020
Approval date [1] 307840 0
29/04/2021
Ethics approval number [1] 307840 0
H-2020-0311
Ethics committee name [2] 308631 0
University of New England Human Research Ethics Committee
Ethics committee address [2] 308631 0
Ethics committee country [2] 308631 0
Australia
Date submitted for ethics approval [2] 308631 0
04/02/2021
Approval date [2] 308631 0
05/02/2021
Ethics approval number [2] 308631 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108694 0
Prof Michael Nilsson
Address 108694 0
Centre for Rehab Innovations
University of Newcastle
University Drive
Callaghan NSW 2308
Country 108694 0
Australia
Phone 108694 0
+61 2 4042 0570
Fax 108694 0
Email 108694 0
[email protected]
Contact person for public queries
Name 108695 0
Elizabeth Ditton
Address 108695 0
Centre for Rehab Innovations, University of Newcastle, University Drive, Callaghan NSW 2308
Country 108695 0
Australia
Phone 108695 0
+61 2 4042 0738
Fax 108695 0
Email 108695 0
[email protected]
Contact person for scientific queries
Name 108696 0
Elizabeth Ditton
Address 108696 0
Centre for Rehab Innovations, University of Newcastle, University Drive, Callaghan NSW 2308
Country 108696 0
Australia
Phone 108696 0
+61 2 4042 0738
Fax 108696 0
Email 108696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy and confidentiality for the cohort


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11788Study protocol  [email protected] Will be provided directly to researchers pending r... [More Details]
11789Ethical approval  [email protected] Will be provided directly to researchers pending r... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIAssessing the Efficacy of an Individualized Psychological Flexibility Skills Training Intervention App for Medical Student Burnout and Well-being: Protocol for a Randomized Controlled Trial2022https://doi.org/10.2196/32992
EmbaseEvaluation of an App-Delivered Psychological Flexibility Skill Training Intervention for Medical Student Burnout and Well-being: Randomized Controlled Trial.2023https://dx.doi.org/10.2196/42566
N.B. These documents automatically identified may not have been verified by the study sponsor.