Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000181404
Ethics application status
Approved
Date submitted
5/08/2024
Date registered
17/02/2025
Date last updated
17/02/2025
Date data sharing statement initially provided
17/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Wellbeing at Scale – Effectiveness of Two Versions of the Be Well Plan for Mental Health and Wellbeing in University Students
Scientific title
Effectiveness of Two Versions of the Be Well Plan in Managing Symptoms of Depression and Anxiety and Enhancing Mental Wellbeing in University Students
Secondary ID [1] 312173 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 333827 0
Depression 333826 0
Eating concerns 334681 0
Stress 334682 0
Shape Concerns 335666 0
Weight Concerns 335665 0
Condition category
Condition code
Mental Health 331253 331253 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 330497 330497 0 0
Anxiety
Mental Health 330496 330496 0 0
Depression
Mental Health 330498 330498 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the Be Well Plan program, an evidence based mental health and wellbeing program. The Be Well Plan is a five week program introducing participants to a range of evidence-based skills and activities (derived from a large meta-analysis) to assist mental wellbeing. These include, for example, self-compassion, mindfulness, and thought challenging. Participants will be randomised into the Flipped Classroom Format (intervention).

The Flipped Classroom Format (intervention) entails participants completing one-hour of self-paced pre-session activities on psychological concepts, followed by attending a weekly one-hour facilitated group session with approximately 5-30 participants (in-person or online) over five weeks. The group sessions are delivered by trained Be Well Plan facilitators, all of whom are researchers and/or psychologists and who have received accreditation to deliver the program from Be Well Co.

The Flipped Classroom pre-session material includes watching pre-recorded videos (approximately 30-minutes), accessed online via a learning management system (CANVAS), and completing the Be Well Plan workbook activities and reflections (approximately 30-minutes). These activities aim to build on the content covered during each Be Well Plan session and may include reflecting on personal strengths and values, and identifying sources of meaning in one's life. Participants will also be required to practise evidence-based wellbeing activities of their choice in their Be Well Plan, that they are taught in the program to start building habits. These activities, for example, include practising mindfulness meditation, completing a daily mindful walk or cultivating personal strengths in daily activities. Participants will be enrolled in the Be Well Plan course on CANVAS and the videos and activities are released each week to align with the sessions.

The content of the of the flipped classroom format includes the following:
Week 1:
Pre-session: The video content covers - An introduction to the Be Well Plan, theories and an understanding of mental health and wellbeing, and an introduction to mindfulness and guided mindfulness activities. The Be Well Plan workbook includes reflections on the participants learnings from the videos and participants unique Be Well Plan which is created each week from the mental wellbeing activities participants choose.

Group Session 1: The participants then join a weekly one-hour facilitated group session (in-person or online) which involves reflections and discussions on the pre-session materials and reviewing their Be Well Plan for that week.

Week 2:
Pre-session: The video content covers - A Reflection on last week, an introduction to self-compassion, and an understanding of participants current mental health profile. The Be Well Plan workbook includes reflections on the participants learnings from the videos, self-compassion exercises, and participants unique Be Well Plan.

Group Session 2: The participants then join a weekly one-hour facilitated group session (in-person or online) which involves reflections and discussions on the pre-session materials and reviewing their Be Well Plan for that week.

Week 3:
Pre-session: The video content covers - A reflection on last week, understanding resources, strengths, and challenges, and setting priorities for working on mental wellbeing. The Be Well Plan workbook includes reflections on the participants learnings from the videos, understanding their own strengths and challenges, and completing participants Be Well Plan.

Group Session 3: The participants then join a weekly one-hour facilitated group session (in-person or online) which involves reflections and discussions on the pre-session materials and reviewing their Be Well Plan for that week.

Week 4:
Pre-session: The video content covers - A reflection on last week, understanding stress, introducing coping styles, cognitive strategies for managing stress (e.g., thought defusion) and when to seek additional support for mental health. The Be Well Plan workbook includes reflections on the participants learnings from the videos, understanding their own coping styles, and completing their Be Well Plan.

Group Session 4: The participants then join a weekly one-hour facilitated group session (in-person or online) which involves reflections and discussions on the pre-session materials and reviewing their Be Well Plan for that week.

Week 5:
Pre-session: The video content covers - A reflection on the Be Well Plan program, introducing realistic optimism and positive re-framing, and setting mental wellbeing goals for the future. The Be Well Plan workbook includes reflections on the participants learnings from the videos, setting mental health goals and reflecting on how to continue their Be Well Plan once the program finishes.

Group Session 5: The participants then join the final weekly one-hour facilitated group session (in-person or online) which involves reflections and discussions on the pre-session materials and reviewing how they can continue using their Be Well Plan once the program ends.

Adherence will be monitored using adherence checklists at each session, and sending a follow up email to participants who did not attend the group session.
Intervention code [1] 328616 0
Treatment: Other
Comparator / control treatment
The control group is the Be Well Plan (Standard Format). Results from participants in the Standard Format will be compared to results from participants in the Flipped Classroom Format to determine the effect of delivery on key outcomes.

The Be Well Plan (Standard Format) involves a weekly 2hr session delivered either online or face-to-face. Participants will attend 1 x 2hr sessions weekly for 5 weeks. This will be delivered either online in the participants' environment or face-to-face in a university classroom. The session will be delivered in a group setting of approximately 5-20 participants/group. This will be delivered by trained Be Well Plan facilitators, all of whom are researchers and/or mental health clinicians and who have received accreditation to deliver the session from the Be Well Co.
Control group
Active

Outcomes
Primary outcome [1] 338270 0
Mental Wellbeing
Assessment method [1] 338270 0
Warwick Edinborough Mental Wellbeing Scale
Timepoint [1] 338270 0
Baseline, at intervention completion (primary timepoint) and three months post-intervention completion
Primary outcome [2] 338269 0
Anxiety
Assessment method [2] 338269 0
Generalized Anxiety Disorders Assessment-7
Timepoint [2] 338269 0
Baseline, at intervention completion (primary time point) and three months post intervention completion
Primary outcome [3] 338268 0
Depression
Assessment method [3] 338268 0
Patient Health Questionnaire-9
Timepoint [3] 338268 0
Baseline, at intervention completion (primary time point) and three months post intervention completion
Secondary outcome [1] 435226 0
Resilience
Assessment method [1] 435226 0
Connor-Davidson Resilience Scale
Timepoint [1] 435226 0
Baseline, at intervention completion and three months post-intervention completion
Secondary outcome [2] 441426 0
Eating Disorders
Assessment method [2] 441426 0
Eating Disorder Examination Questionnaire (EDE-Q 7) with additional behavioural questions from EDE-Q 28. This will be assessed as a composite outcome.
Timepoint [2] 441426 0
Baseline, at intervention completion and three months post intervention completion
Secondary outcome [3] 441419 0
Chronic Stress
Assessment method [3] 441419 0
Psychosocial and lifestyle questionnaire
Timepoint [3] 441419 0
Baseline, at intervention completion and three months post intervention completion
Secondary outcome [4] 441416 0
Body Appreciation
Assessment method [4] 441416 0
Body Appreciation Scale (BAS-2)
Timepoint [4] 441416 0
Baseline, at intervention completion and three months post intervention completion
Secondary outcome [5] 435229 0
Eating Disorder Impairment
Assessment method [5] 435229 0
Clinical Impairment Assessment Questionnaire
Timepoint [5] 435229 0
Baseline, at intervention completion and three months post-intervention completion
Secondary outcome [6] 435227 0
Self-Compassion
Assessment method [6] 435227 0
Self-Compassion Scale
Timepoint [6] 435227 0
Baseline, at intervention completion and three 3 months post-intervention completion
Secondary outcome [7] 441420 0
Health services utilisation
Assessment method [7] 441420 0
Use of health and social service questionnaire
Timepoint [7] 441420 0
Baseline, at intervention completion and three months post intervention completion
Secondary outcome [8] 441417 0
Body Image Flexibility
Assessment method [8] 441417 0
Body Image Acceptance and Action Questionnaire Five (BI-AAQ-5)
Timepoint [8] 441417 0
Baseline, at intervention completion and three months post intervention completion

Eligibility
Key inclusion criteria
University students enrolled at the University of Sunshine Coast who are 18 years of age or older. Students who have identified that they are experiencing eating or body image concerns will be invited to take part in interviews/focus groups about the Be Well Plan for eating and body image concerns.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will occur and allocation will be completed by a third party (researcher) who is not involved with the delivery of the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation will be used for randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/03/2025
Actual
Date of last participant enrolment
Anticipated
14/11/2025
Actual
Date of last data collection
Anticipated
26/12/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 316540 0
University
Name [1] 316540 0
University of Sunshine Coast
Country [1] 316540 0
Australia
Primary sponsor type
University
Name
University of Sunshine Coast
Country
Australia
Secondary sponsor category [1] 318723 0
None
Name [1] 318723 0
None
Country [1] 318723 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315333 0
Human Research Ethics Committee of the University of the Sunshine Coast
Ethics committee address [1] 315333 0
Ethics committee country [1] 315333 0
Australia
Date submitted for ethics approval [1] 315333 0
25/03/2024
Approval date [1] 315333 0
08/05/2024
Ethics approval number [1] 315333 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 134370 0
Dr Kathina Ali
Address 134370 0
University of the Sunshine Coast, 90 Sippy Downs Dr, Sippy Downs, QLD, 4556
Country 134370 0
Australia
Phone 134370 0
+61 7543 02872
Email 134370 0
kali@usc.edu.au
Contact person for public queries
Name 134371 0
Kathina Ali
Address 134371 0
University of the Sunshine Coast, 90 Sippy Downs Dr, Sippy Downs, QLD, 4556
Country 134371 0
Australia
Phone 134371 0
+61 7543 02872
Email 134371 0
kali@usc.edu.au
Contact person for scientific queries
Name 134372 0
Kathina Ali
Address 134372 0
University of the Sunshine Coast, 90 Sippy Downs Dr, Sippy Downs, QLD, 4556
Country 134372 0
Australia
Phone 134372 0
+61 7543 02872
Email 134372 0
kali@usc.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.