Trial Review

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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
Date results information initially provided
17/01/2022
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] 302904 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 319914 0
Condition category
Condition code
Mental Health 317858 317858 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 318202 318202 0 0
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] 319190 0
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] 326184 0
Depression severity as measured using the PHQ-9
Timepoint [1] 326184 0
Pre-intervention and post-completion of program
Primary outcome [2] 326185 0
Anxiety severity as measured using the GAD-7
Timepoint [2] 326185 0
Pre-intervention and post-completion of program
Primary outcome [3] 326186 0
Level of mental wellbeing as measured using the Warwick Edinburgh Mental Well-Being Scale
Timepoint [3] 326186 0
Pre-intervention and post-completion of program
Secondary outcome [1] 390416 0
Level of resilience as measured using the Connor-Davidson Resilience Scale
Timepoint [1] 390416 0
Pre-intervention and post-completion of programm
Secondary outcome [2] 390425 0
Level of self-efficacy as measured using the General Self-efficacy Scale
Timepoint [2] 390425 0
Pre-intervention and post-completion of program
Secondary outcome [3] 390426 0
Level of intolerance of uncertainty as measured using the Intolerance of Uncertainty Scale
Timepoint [3] 390426 0
Pre-intervention and post-completion of program
Secondary outcome [4] 390427 0
Level of cognitive flexibility as measured using the Cognitive Flexibility Scale
Timepoint [4] 390427 0
Pre-intervention and post-completion of program
Secondary outcome [5] 390428 0
Level of sense of control as measured using the Sense of Control Measure
Timepoint [5] 390428 0
Pre-intervention and post-completion of program
Secondary outcome [6] 390429 0
Level of life satisfaction using the Satisfaction with Life Scale
Timepoint [6] 390429 0
Pre-intervention and post-completion of program
Secondary outcome [7] 390430 0
Response to pandemic related study-specific questions
Timepoint [7] 390430 0
Pre-intervention and post-completion of program
Secondary outcome [8] 392098 0
Level of self-care assessed using study-specific self-care questions
Timepoint [8] 392098 0
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)
SA

Funding & Sponsors
Funding source category [1] 307324 0
University
Name [1] 307324 0
Flinders University
Country [1] 307324 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road, Bedford Park South Australia 5042
Country
Australia
Secondary sponsor category [1] 307963 0
None
Name [1] 307963 0
Address [1] 307963 0
Country [1] 307963 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307414 0
Flinders Social and Behavioural Research Ethics Committee
Ethics committee address [1] 307414 0
Union Basement Building
Flinders University
Sturt Road, Bedford Park, South Australia, 5042
Ethics committee country [1] 307414 0
Australia
Date submitted for ethics approval [1] 307414 0
Approval date [1] 307414 0
24/02/2020
Ethics approval number [1] 307414 0

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 107154 0
Dr Dan Fassnacht
Address 107154 0
College of Education, Psychology & Social Work
Flinders University

Sturt Road, Bedford Park South Australia 5042
Country 107154 0
Australia
Phone 107154 0
+61 8 8201 2621
Fax 107154 0
Email 107154 0
[email protected]
Contact person for public queries
Name 107155 0
Dr Dan Fassnacht
Address 107155 0
College of Education, Psychology & Social Work
Flinders University

Sturt Road, Bedford Park South Australia 5042
Country 107155 0
Australia
Phone 107155 0
+61 8 8201 2621
Fax 107155 0
Email 107155 0
[email protected]
Contact person for scientific queries
Name 107156 0
Dr Dan Fassnacht
Address 107156 0
College of Education, Psychology & Social Work
Flinders University

Sturt Road, Bedford Park South Australia 5042
Country 107156 0
Australia
Phone 107156 0
+61 8 8201 2621
Fax 107156 0
Email 107156 0
[email protected]

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, [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9893Ethical approval  [email protected]
9895Informed consent form  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA 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.2022https://dx.doi.org/10.2196/37292
N.B. These documents automatically identified may not have been verified by the study sponsor.