Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000447651
Ethics application status
Approved
Date submitted
11/04/2023
Date registered
2/05/2023
Date last updated
17/04/2024
Date data sharing statement initially provided
2/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Social Media Psychoeducation and Well-being Outcomes
Scientific title
The effect of a cognitive behavioural therapy (CBT)-based micro-intervention on the negative impact of social networking site use on well-being in healthy adults and adolescents.
Secondary ID [1] 309403 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well-being 329636 0
Condition category
Condition code
Mental Health 326559 326559 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed study aims to examine the effectiveness of the Social Media Aware (SMA) program in improving mental health outcomes via a randomised controlled trial (RCT). The SMA program based on cognitive behaviour therapy (CBT) designed to help reduce the negative impact of social media use on well-being outcomes. It is an interactive video written and narrated by the primary author, a Clinical Psychologist with 19 years clinical experience and 4.5 years of experience as a Research Psychologist.

Participants will be informed that the study is assessing the outcomes of two social media psychoeducation videos and that they will be randomly allocated to view one of the videos, in addition to undertaking other survey-related tasks. When accessing the survey via the link provided, participants will be randomly allocated to either the experiment group (EG) or the control group (CG) via the Qualtrics online survey platform.

Participants in the EG will be requested to complete baseline data (T1) before watching the 13-minute SMA micro-intervention video, which will include brief interactive tasks. Participants will also be provided with a record form containing key points from the video and will be requested to record their answers to interactive tasks, which they will keep for their future reference (see below for video summary). They will then be requested to passively view the platform Instagram for 10 minutes before completing further surveys (T2; and further surveys 3 days later T3).

Overview of intervention video content:
Psychoeducation - Why highly visual social networking site (HVSNS) exposure can be harmful for well-being (passive use and social comparison). Why people tend to post more positive information then negative, leading to inaccurate social comparisons. The role of thoughts in how we feel and importance of questioning.
Thought challenging - Examples of thoughts stemming from social comparisons that could be triggered by HVSNS use and how to challenge. Examples of general helpful coping statements.

Written tasks (during video) -“What negative thoughts typically come up for you when using HVSNS?”
-“Write down any thought challenging questions that were generated while watching the video that you think could be useful for managing any negative thoughts triggered in the future (please record two, if possible)”.
-“Write down any coping statements that may be helpful for you to use in the future (please record two, if possible)”.

The study will occur online. To assess adherence and fidelity, the amount of time spent viewing the videos will be recorded and participants will be asked to confirm the percentage of time they spent undertaking the Instagram exposure task passively immediately following the task.
Intervention code [1] 325838 0
Prevention
Comparator / control treatment
In place of the intervention video, participants in the active CG will view a 10-minute educational video outlining the development of the Instagram platform and algorithms, with no reference to mental health outcomes or strategies to manage such. Participants will also be asked to engage in a written task at the end of the survey, asking them to summarise the key points of the video, to provide an interactive learning task similar to that done in the EG (see below for summary of control video content). All other survey and passive Instagram use requirements outlined above will be identical.

Overview of control video(s) content:

(Two videos separated by written task) -Discussion of the people who started the platform, the development of the idea, visual nature of the platform, the growth in popularity and money raised over the years, financial offers made to buy the platform, updates of platform features, competitors in the market and the incorporation of advertisements to make profit.
-What algorithms are and how they work, potential problems and benefits of algorithms.

Written tasks (at video completion) “Please record some of the key messages you recall from the video about the development of Instagram that you found interesting”.
“Please record any of the potential negative outcomes of algorithms that were discussed (please record two, if possible).
“Please record any potential benefits of algorithms for the user (please record two, if possible).”

Links to the CG videos are below:
The Story Behind the Rise of Instagram - YouTube
https://www.youtube.com/watch?v=wjpFPsdfuVA
Control group
Active

Outcomes
Primary outcome [1] 334402 0
Emotional well-being (positive and negative affect). Emotional well-being will be measured by the short form of the Positive and Negative Affect Schedule (Watson et al., 1988).
Timepoint [1] 334402 0
All outcomes will be assessed prior to intervention (T1), immediately post intervention/ Instagram task - (T2) and again 3 days later (T3).
Primary outcome [2] 334403 0
Cognitive well-being (life satisfaction). Cognitive well-being will be measured by the Satisfaction with Life Scale (SWLS; (Diener et al., 1985).
Timepoint [2] 334403 0
All outcomes will be assessed prior to intervention (T1), immediately post intervention/ Instagram task - (T2) and again 3 days later (T3).
Primary outcome [3] 334404 0
State body satisfaction. This will be measured by three visual analogue scales (VAS), as was done in previous media and social media exposure studies (Heinberg & Thompson, 1995, Slater, 2019, Gordon et al., 2021; Durkin & Paxton, 2002). Participants will be asked to rate how they are feeling in the moment by moving a vertical marker to the appropriate place on a horizontal line, ranging from 0 (not at all) to 100 (extremely). Three items were used to measure state body satisfaction: “satisfied with my overall appearance”, “satisfied with my weight,” and “satisfied with my body shape.” Responses will be averaged with higher scores will indicating higher body satisfaction.
Timepoint [3] 334404 0
All outcomes will be assessed prior to intervention (T1), immediately post intervention/ Instagram task - (T2) and again 3 days later (T3).
Secondary outcome [1] 420534 0
Negative automatic thoughts (frequency and believability). The Automatic Thoughts Questionnaire – Believability (ATQ-B-15; Netemeyer et al., 2002) will be used to assess the degree of believability of negative automatic thoughts about the self. The frequency of negative automatic thoughts was measured by the ATQ-N. (ATQ-N-15; Hollon & Kendall, 1980; Netemeyer et al., 2002).
Timepoint [1] 420534 0
All outcomes will be assessed prior to intervention (T1), immediately post intervention/ Instagram task - (T2) and again 3 days later (T3).

Eligibility
Key inclusion criteria
Participants will be required to have an Instagram account for at least 1 week and own a smartphone with access to this Instagram account on the day of intervention. Participants must also have access to a laptop/another piece of technology on the day of the initial experiment, be fluent in English, and be at least 16 years of age.
Minimum age
16 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
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation by computer program (Qualtrics)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2023
Actual
31/07/2023
Date of last participant enrolment
Anticipated
1/12/2023
Actual
16/03/2024
Date of last data collection
Anticipated
4/01/2024
Actual
19/03/2024
Sample size
Target
224
Accrual to date
Final
159
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313597 0
University
Name [1] 313597 0
University of Adelaide
Country [1] 313597 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace SA 5005
Country
Australia
Secondary sponsor category [1] 315386 0
None
Name [1] 315386 0
Address [1] 315386 0
Country [1] 315386 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312774 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 312774 0
Ethics committee country [1] 312774 0
Australia
Date submitted for ethics approval [1] 312774 0
03/05/2023
Approval date [1] 312774 0
17/07/2023
Ethics approval number [1] 312774 0
H-2023-154

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

Contacts
Principal investigator
Name 125866 0
Prof Rachel Roberts
Address 125866 0
The University of Adelaide, North Terrace SA 5005
Country 125866 0
Australia
Phone 125866 0
+61 08 8313 5228
Fax 125866 0
Email 125866 0
[email protected]
Contact person for public queries
Name 125867 0
Zoe Herriman
Address 125867 0
The University of Adelaide, North Terrace SA 5005
Country 125867 0
Australia
Phone 125867 0
+61413328533
Fax 125867 0
Email 125867 0
[email protected]
Contact person for scientific queries
Name 125868 0
Zoe Herriman
Address 125868 0
The University of Adelaide, North Terrace SA 5005
Country 125868 0
Australia
Phone 125868 0
+61413328533
Fax 125868 0
Email 125868 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?
All de-identified collected data
When will data be available (start and end dates)?
Data is expected to be available following publication, with no end date determined
Available to whom?
Researchers who provide a methodologically sound proposal will be able to access the data, as per the discretion of the data custodian.
Available for what types of analyses?
Any reasonable purpose, such as a meta-analysis
How or where can data be obtained?
Access subject to approvals by data custodian Professor Rachel Roberts - [email protected]


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.