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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 information initially 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Burnout

Psychological Wellbeing

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Mental Health

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]

Prevention

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

Burnout:
Maslach Burnout Inventory – General Survey for Students (MBI – GS (S)) (Schaufeli, Martínez, Pinto, Salanova, & Bakker, 2002)

Timepoint [1]

• T1: Pre-intervention
• T2: Post-intervention (5 weeks after randomisation into Stage 2)

Secondary outcome [1]

Wellbeing:
Mental Health Continuum – Short Form (MHC-SF) (Keyes, 2005)

Timepoint [1]

• T1: Pre-intervention
• T2: Post-intervention (5 weeks after randomisation into Stage 2)

Secondary outcome [2]

Psychological Flexibility:
Multidimensional Psychological Flexibility Inventory (MPFI) – Short Form (J. L. Rolffs et al., 2018)

Timepoint [2]

• T1: Pre-intervention
• T2: Post-intervention (5 weeks after randomisation into Stage 2)

Secondary outcome [3]

Mental health:
Depression Anxiety and Stress Scale-21 (DASS-21) (Lovibond & Lovibond, 1995)

Timepoint [3]

• 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]

University

Name [1]

University of Newcastle

Address [1]

University Drive
Callaghan
NSW 2308

Country [1]

Australia

Funding source category [2]

University

Name [2]

Centre for Rehab Innovations, University of Newcastle

Address [2]

University of Newcastle
University Drive
Callaghan NSW 2308

Country [2]

Australia

Funding source category [3]

University

Name [3]

Priority Research Centre for Stroke and Brain Injury, University of Newcastle

Address [3]

University of Newcastle
University Drive
Callaghan NSW 2308

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Brendon Knott

Address [1]

Contextual Interventions / Esteem Psychology
735 Hunter Street
Newcastle West NSW 2302

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

University of Newcastle
University Drive
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/11/2020

Approval date [1]

29/04/2021

Ethics approval number [1]

H-2020-0311

Ethics committee name [2]

University of New England Human Research Ethics Committee

Ethics committee address [2]

University of New England, Elm Avenue, Armidale NSW 2351

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

04/02/2021

Approval date [2]

05/02/2021

Ethics approval number [2]

Summary

Brief summary

Burnout is a common problem among medical doctors, with difficulties emerging as early as undergraduate medical training. The current study will deliver a psychological flexibility skills training intervention (Acceptance and Commitment Training) to medical students via an online App, which aims to provide early intervention to improve burnout and wellbeing outcomes. The App-based delivery format aims to make the intervention accessible among a time-poor group that tends not to seek out support due to perceived stigma, as well as facilitate the delivery of an intervention that can be adapted to suit individual skill-building needs (individualised). We will compare the efficacy of an individualised version of the App with a non-individualised version. We expect that medical students who complete either version of the intervention will demonstrate better burnout and wellbeing outcomes than students who have not completed the intervention. We also expect that students who receive the individualised version will benefit more from the intervention than those who receive the non-individualised version.

Trial website

centrerehabinnovations.com.au/bisi

Trial related presentations / publications

Public notes

Adopting intervention methodologies that account for individual differences is becoming increasingly important, as there is a high degree of heterogeneity evident both in the way burnout symptoms develop between individuals over time (Mäkikangas & Kinnunen, 2016) and in individual recovery patterns during and following burnout interventions (Ahola, Toppinen-Tanner, & Seppänen, 2017; Kinnunen, Puolakanaho, Tolvanen, Mäkikangas, & Lappalainen, 2019; Mäkikangas & Kinnunen, 2016). These findings demonstrate that individuals might require different types of intervention that target their individual risk factors in order to experience improvements in burnout risk and wellbeing outcomes (Berjot, Altintas, Grebot, & Lesage, 2017; Hofmann & Hayes, 2019; Kinnunen et al., 2019; Mäkikangas & Kinnunen, 2016; J. L. Rolffs, Rogge, & Wilson, 2018).
Modularised interventions that are individualised to target specific identified needs of each person engaging in a program can address this issue of heterogeneity. By identifying which ACT skills individuals may require assistance with, and delivering skills training activities that align with these identified risk factors, we anticipate that burnout prevention and wellbeing interventions can be delivered with increased efficacy, efficiency, and individual relevance (Steven C. Hayes et al., 2019; Hofmann & Hayes, 2019).

Contacts

Principal investigator

Name

Prof Michael Nilsson

Address

Centre for Rehab Innovations
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 4042 0570

Fax

[email protected]

Contact person for public queries

Name

Ms Elizabeth Ditton

Address

Centre for Rehab Innovations, University of Newcastle, University Drive, Callaghan NSW 2308

Country

Australia

Phone

+61 2 4042 0738

Fax

[email protected]

Contact person for scientific queries

Name

Ms Elizabeth Ditton

Address

Centre for Rehab Innovations, University of Newcastle, University Drive, Callaghan NSW 2308

Country

Australia

Phone

+61 2 4042 0738

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Privacy and confidentiality for the cohort

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11788	Study protocol			[email protected]	Will be provided directly to researchers pending r... [More Details]
11789	Ethical approval			[email protected]	Will be provided directly to researchers pending r... [More Details]

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Preliminary support for efficacy of the app in tra... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Evaluation of an App-Delivered Psychological Flexibility Skill Training Intervention for Medical Student Burnout and Well-being: Randomized Controlled Trial.	2023	https://dx.doi.org/10.2196/42566
Dimensions AI	Assessing the Efficacy of an Individualized Psychological Flexibility Skills Training Intervention App for Medical Student Burnout and Well-being: Protocol for a Randomized Controlled Trial	2022	https://doi.org/10.2196/32992

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically