Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001614886
Ethics application status
Approved
Date submitted
26/09/2021
Date registered
26/11/2021
Date last updated
23/11/2022
Date data sharing statement initially provided
26/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Learning to Thrive: Investigating the effects of an online intervention program for university students' mental health and well-being
Scientific title
Learning to Thrive: Investigating the effects of an online intervention program (behavioural activation, self-compassion, social identification) for university students' mental health and well-being
Secondary ID [1] 305414 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Academic worry 323784 0
Anxiety 324025 0
Depression 324026 0
Condition category
Condition code
Mental Health 321296 321296 0 0
Anxiety
Mental Health 321530 321530 0 0
Depression
Mental Health 321531 321531 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two online intervention groups. The first condition includes training modules in Behavioural Activation (BA) and Self-compassion. The second online intervention group includes training modules on Behavioural Activation (BA), Self-compassion (SC), and Social Identification (SI).
First, after consenting, participants will answer a questionnaire containing well-being (i.e., anxiety, depression, academic worry, social anxiety, loneliness, and life-satisfaction) and psychological processes (self-compassion, behavioural activation, social identification, trait avoidance, and intolerance of uncertainty) measures. They will then write about a university-related issue that is worrying them. They will then be randomly assigned to one of three online conditions: the Behavioural Activation + Self-Compassion (BA+SC) condition; the Behavioural Activation + Self-Compassion + Social identification condition (BA+SC+SI); or the control condition. Each one of these conditions will take a total of five sessions, each of 15 to 30 minutes to avoid fatigue. The sessions will be administered once per week for 5 weeks. Email reminders will be sent to participants reminding them to complete each session.

The amount of time that participants spend on the homework exercises will be at their discretion. Homework tasks will be referred back to in future sessions to encourage homework completion.
To monitor adherence to the training program, researchers will review participant responses through the online program.

In the BA+SC condition (in line with Tee, 2015), participants will first engage in behavioural activation. The first step will be to do an exercise in which they learn about the concept avoidance, and how it relates to their current university-related worry (introduction of concepts). They will then do an activity that helps identify the thoughts, feelings and behaviours related to their avoidance (activity monitoring). In the next activity, they will determine a university-related goal that will help them address the worry delineated in the first exercise (assessing goals and values). Once this goal has been established, they will do an activity that helps them schedule up to two activities in an activity planner (activity scheduling). Lastly, participants will be instructed to practice the activities by following the schedule they have created (homework). After the behavioural activation exercise, participants will then engage in self-compassion exercises. Participants will be first introduced to two concepts in addition to avoidance, namely isolation and self-judgement, in the context of their university life. They will then learn about individual-level concepts to counter these negative emotions/thoughts by using self-compassion strategies, namely self-kindness, common humanity and mindfulness (introduction of concepts). After this, they will listen to an audio recording with instructions to practise self-kindness, common humanity and mindfulness (self-compassion exercise).

The BA+SC+SI condition combines behavioural activation and self-compassion with additional elements of social identification and group belonging. Therefore, it follows a similar procedure to the BA+SC condition but with some variations. The first variation is that participants will learn about the importance of social groups in addition to engaging in behavioural activation. They will reflect on the university groups to which they belong to, their importance in providing clear goals/values and in helping achieve their personal goals. After that, participants are directed to think about their university worry (as identified in the first exercise) and how the different groups to which they belong can help them set up priorities and achieve goals that minimise worries. Following this, participants will engage in the activity scheduling and homework, as per the BA+SC condition, with the additional group elements. The self-compassion element will also include group elements. Participants will learn about avoidance, isolation and self-judgement, but instead of focusing on individual-level thoughts/emotions to counter them, they will learn about group-level thoughts/emotions: kindness to all (vs. self-kindness) and community connection (vs. common humanity; mindfulness will stay at the individual level). The audio recording and homework will reflect these variations. Finally, participants will be asked to practice group-level-compassion before the next session and to record this in a worksheet (homework).
Intervention code [1] 321820 0
Behaviour
Comparator / control treatment
In control condition, participants will be asked to review the content of three websites associated with health issues during the 1st, 3rd and 5th session (www.eatforhealth.gov.au; https://www.sunsmart.com.au/; https://www.health.gov.au/health-topics/physical-activity-and-exercise/physical-activity-and-exercise-guidelines-for-all-australians). During the 2nd and 4th sessions, participants in the control group will complete activities such as Sudoku, brain teaser puzzles, word search puzzles and fast arithmetic. Participants will be provided links to puzzles which they can follow to an external site. A timer is built in to the program to indicate to participants when they may stop the activities, to encourage engagement in the tasks for the duration of the session.

The sessions will be administered once per week for 5 weeks and each 15 to 30 minutes in duration to avoid fatigue and reflect the session duration in the intervention groups.. Email reminders will be sent to participants reminding them to complete each session.
Control group
Active

Outcomes
Primary outcome [1] 329075 0
Anxiety (Penn State Worry Questionnaire)
Timepoint [1] 329075 0
Measured at 4 time points.
- Pre-intervention
- Post-intervention (immediately after intervention is completed, primary endpoint.)
- 3-month follow-up post intervention completion
- 6-month follow up post intervention completion
Primary outcome [2] 329076 0
Social Anxiety ( SPIN - Social Phobia Inventory)
Timepoint [2] 329076 0
Measured at 4 time points.
- Pre-intervention
- Post-intervention (immediately after intervention is completed, primary endpoint.)
- 3-month follow-up post intervention completion
- 6-month follow up post intervention completion
Primary outcome [3] 329077 0
Depression (Behavioural Activation for Depression scale -short form BADS-SF)
Timepoint [3] 329077 0
Measured at 4 time points.
- Pre-intervention
- Post-intervention (immediately after intervention is completed, primary endpoint.)
- 3-month follow-up post intervention completion
- 6-month follow up post intervention completion
Secondary outcome [1] 401379 0
Intolerance of Uncertainty (Intolerance of Uncertainty Scales-short form UIS-12)
Timepoint [1] 401379 0
Measured at 4 time points.
- Pre-intervention
- Post-intervention (immediately after intervention is completed)
- 3-month follow-up post intervention completion
- 6-month follow up post intervention completion
Secondary outcome [2] 401380 0
Avoidance (Brief Experiential Avoidance Questionnaire)
Timepoint [2] 401380 0
Measured at 4 time points.
- Pre-intervention
- Post-intervention (immediately after intervention is completed)
- 3-month follow-up post intervention completion
- 6-month follow up post intervention completion
Secondary outcome [3] 401381 0
Loneliness (The UCLA Loneliness scale ULS)
Timepoint [3] 401381 0
Measured at 4 time points.
- Pre-intervention
- Post-intervention (immediately after intervention is completed)
- 3-month follow-up post intervention completion
- 6-month follow up post intervention completion
Secondary outcome [4] 401382 0
Life satisfaction (Satisfaction with Life scale - Pavot & Diener 1991)
Timepoint [4] 401382 0
Measured at 4 time points.
- Pre-intervention
- Post-intervention (immediately after intervention is completed)
- 3-month follow-up post intervention completion
- 6-month follow up post intervention completion
Secondary outcome [5] 401383 0
In-Group identification. Questionnaire as employed by Leach et al., 2008
Timepoint [5] 401383 0
Measured at 4 time points.
- Pre-intervention
- Post-intervention (immediately after intervention is completed)
- 3-month follow-up post intervention completion
- 6-month follow up post intervention completion

Eligibility
Key inclusion criteria
- Current university student (The aims of this project are to help university students manage their academic distress and improve their mental health and well-being. Therefore university students will be the population tested.)
- Proficiency in reading, writing and listening in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil additional exclusion criteria.

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)
A random number, generated off site will be provided to participants. The researcher that provides this number to the participant will have no way of knowing which condition the number is associated with at the point of allocation. Once the participants commences the program, the condition that they have been assigned to will become clear to the researcher.
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). A list of random numbers will be generated off site.
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
Recruiting
Date of first participant enrolment
Anticipated
24/01/2022
Actual
17/07/2022
Date of last participant enrolment
Anticipated
5/12/2022
Actual
Date of last data collection
Anticipated
5/06/2023
Actual
Sample size
Target
100
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309774 0
University
Name [1] 309774 0
Australian National University - Research School of Psychology
Country [1] 309774 0
Australia
Primary sponsor type
Individual
Name
Junwen Chen
Address
Australian National University - Research School of Psychology: Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 310806 0
Individual
Name [1] 310806 0
Diana Cardenas
Address [1] 310806 0
Australian National University - Research School of Psychology: Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country [1] 310806 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309529 0
Human Research Ethics Committee - Australian National University
Ethics committee address [1] 309529 0
Ethics committee country [1] 309529 0
Australia
Date submitted for ethics approval [1] 309529 0
06/09/2021
Approval date [1] 309529 0
08/04/2022
Ethics approval number [1] 309529 0

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

Contacts
Principal investigator
Name 114470 0
Dr Junwen Chen
Address 114470 0
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country 114470 0
Australia
Phone 114470 0
+61 02 612 52038
Fax 114470 0
Email 114470 0
[email protected]
Contact person for public queries
Name 114471 0
Junwen Chen
Address 114471 0
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country 114471 0
Australia
Phone 114471 0
+61 02 612 52038
Fax 114471 0
Email 114471 0
[email protected]
Contact person for scientific queries
Name 114472 0
Junwen Chen
Address 114472 0
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country 114472 0
Australia
Phone 114472 0
+61 02 612 52038
Fax 114472 0
Email 114472 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
The data collected will be presented as group summaries for the purpose of a students Master thesis and in relevant academic journals and conferences. If participants are interested in the findings of the study, they can access a brief report for it on the study Facebook page at https://www.facebook.com/Learning-to-Thrive-Improving-university-students-mental-health-109006848071619/. No participant will be able to access their individual responses, and no individual feedback will be provided.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13376Ethical approval    Once ethical approval has been obtained it can be ... [More Details]



Results publications and other study-related documents

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