ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000180819

Ethics application status

Approved

Date submitted

4/12/2020

Date registered

22/02/2021

Date last updated

17/01/2022

Date data sharing statement initially provided

22/02/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Impact of the Be Well Plan on university students' wellbeing and mental health

Scientific title

Impact of the Be Well Plan on university students' wellbeing and mental health

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Psychological distress

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

The Be Well Plan is a 5-session program that helps individuals to identify and master easy-to-use evidence-based skills to build mental health and wellbeing. The 5 sessions focus on:
1. Getting on the same page: Participants explore the reasons for participating in the program, their personal drivers and acquire basic knowledge on mental health and its malleability. They explore the evidence for different psychological interventions and start creating their first Be Well Plan.
2. Using your mental health profile: Participants reflect on week 1. They get introduced to the concept of self-compassion (as opposed to self-criticism) and how it can be used to learn from failure and shape our thinking patterns. They practice a self-compassion activity. They subsequently pick another activity from the activity bank to add to their Be Well Plan and will set new goals for the week.
3. Your resources and challenges: Participants reflect on week 2. They work with (and are reminded of) existing resources to their own mental health via two practical activities. They are introduced to a second activity finder that maps evidence-based activities to each of the challenges and resources. They pick a new activity from the activity bank to add to the Be Well Plan.
4. Stress, coping and resilience: Participants reflect on week 3. This session focuses on stressful times and effective ways to cope (e.g., avoidance-focused coping versus more helpful ways, e.g. problem-focused coping). They are asked to identify social support for when times get tough and are reminded of various professional services.
5. Future-proofing your Be Well Plan: Participants reflect on the past 4 weeks. Participants will build their final Be Well Plan, which aims to summarise key learnings from the previous weeks into a standalone plan. They summarise what their best possible mental health looks like, highlight their unique drivers and motivations, and existing resources and challenges in their life. They identify their key supporters and reflect on what support services they need in case of emergency.

Weekly 2-hour online sessions are delivered by trained facilitators via Zoom in a group format (up to 20 participants per group). Facilitators have undergone extensive training in delivering psychological skills training; the program was specifically designed to be facilitated by up-skilled trainers from the community. Attendance of participants will be monitored with session attendance checklists.

Intervention code [1]

Prevention

Comparator / control treatment

Wait-list control: intervention will be offered to wait-list participants after 6 weeks intervention period

Control group

Active

Outcomes

Primary outcome [1]

Depression severity as measured using the PHQ-9

Timepoint [1]

Pre-intervention and post-completion of program

Primary outcome [2]

Anxiety severity as measured using the GAD-7

Timepoint [2]

Pre-intervention and post-completion of program

Primary outcome [3]

Level of mental wellbeing as measured using the Warwick Edinburgh Mental Well-Being Scale

Timepoint [3]

Pre-intervention and post-completion of program

Secondary outcome [1]

Level of resilience as measured using the Connor-Davidson Resilience Scale

Timepoint [1]

Pre-intervention and post-completion of programm

Secondary outcome [2]

Level of self-efficacy as measured using the General Self-efficacy Scale

Timepoint [2]

Pre-intervention and post-completion of program

Secondary outcome [3]

Level of intolerance of uncertainty as measured using the Intolerance of Uncertainty Scale

Timepoint [3]

Pre-intervention and post-completion of program

Secondary outcome [4]

Level of cognitive flexibility as measured using the Cognitive Flexibility Scale

Timepoint [4]

Pre-intervention and post-completion of program

Secondary outcome [5]

Level of sense of control as measured using the Sense of Control Measure

Timepoint [5]

Pre-intervention and post-completion of program

Secondary outcome [6]

Level of life satisfaction using the Satisfaction with Life Scale

Timepoint [6]

Pre-intervention and post-completion of program

Secondary outcome [7]

Response to pandemic related study-specific questions

Timepoint [7]

Pre-intervention and post-completion of program

Secondary outcome [8]

Level of self-care assessed using study-specific self-care questions

Timepoint [8]

Pre-intervention and post-completion of program

Eligibility

Key inclusion criteria

Any student from Flinders University

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 computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Intention-to-treat

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

6/08/2020

Date of last participant enrolment

Anticipated

Actual

13/05/2021

Date of last data collection

Anticipated

Actual

18/06/2021

Sample size

Target

120

Accrual to date

Final

215

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

Sturt Road, Bedford Park South Australia 5042

Country [1]

Australia

Primary sponsor type

University

Name

Flinders University

Address

Sturt Road, Bedford Park South Australia 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Flinders Social and Behavioural Research Ethics Committee

Ethics committee address [1]

Union Basement Building
Flinders University
Sturt Road, Bedford Park, South Australia, 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/02/2020

Ethics approval number [1]

Summary

Brief summary

The Be Well Plan comprises of five online group sessions (2 hours each) which are delivered by trained facilitaters. The program helps participants identify strategies to build and maintain strong levels of mental health, wellbeing and resilience. A particular strength of the program is that participants develop their own, personalised wellbeing plan including activities that they identify as beneficial during participation in the program. All activities in the Be Well Plan are evidence-based and were selected from an extensive meta-analysis of psychological interventions to improve mental wellbeing conducted by the team members.
The proposed research aims to investigate the efficacy of the Be Well Plan in a cohort of Flinders university students. We plan to recruit 120 student who will be randomised to the interactive, online facilitated version of the Be Well Plan intervention or to a wait-list control condition.
Validated measures will be used to assess psychological distress (i.e., anxiety, mood and stress), wellbeing (emotional, social and psychological), and resilience in order to evaluate pre- to post-intervention changes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Dan Fassnacht

Address

College of Education, Psychology & Social Work
Flinders University

Sturt Road, Bedford Park South Australia 5042

Country

Australia

Phone

+61 8 8201 2621

Fax

dan.fassnacht@flinders.edu.au

Contact person for public queries

Name

Dan Fassnacht

Address

College of Education, Psychology & Social Work
Flinders University

Sturt Road, Bedford Park South Australia 5042

Country

Australia

Phone

+61 8 8201 2621

Fax

dan.fassnacht@flinders.edu.au

Contact person for scientific queries

Name

Dan Fassnacht

Address

College of Education, Psychology & Social Work
Flinders University

Sturt Road, Bedford Park South Australia 5042

Country

Australia

Phone

+61 8 8201 2621

Fax

dan.fassnacht@flinders.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 pre- and post-intervention data for the primary outcome measures.

When will data be available (start and end dates)?

Following publication, no end date.

Available to whom?

Available to researchers who provide a methodologically sound proposal.

Available for what types of analyses?

Only to achieve the aims in the approved proposal.

How or where can data be obtained?

Access subject to approvals by Principal Investigator: Dan Fassnacht, dan.fassnacht@flinders.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9893	Ethical approval			dan.fassancht@flinders.edu.au
9895	Informed consent form			dan.fassancht@flinders.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A Group-Facilitated, Internet-Based Intervention to Promote Mental Health and Well-Being in a Vulnerable Population of University Students: Randomized Controlled Trial of the Be Well Plan Program.	2022	https://dx.doi.org/10.2196/37292

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

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