Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001057774
Ethics application status
Approved
Date submitted
26/07/2022
Date registered
29/07/2022
Date last updated
13/04/2024
Date data sharing statement initially provided
29/07/2022
Date results information initially provided
13/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to assess the feasibility, acceptability, and impact of an intervention to address the potential effects of social networking site use on well-being.
Scientific title
A pilot study to assess the feasibility, acceptability, and impact of a CBT-based micro-intervention to address the potential effects of social networking site use on well-being.
Secondary ID [1] 307167 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social media use 326707 0
depression
 327193 0
Condition category
Condition code
Mental Health 323951 323951 0 0
Depression
Public Health 323952 323952 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will take the form of a 13-minute educational video, introducing people to cognitive restructuring techniques (CBT-based) aimed at reducing the negative emotional impact of highly visual social networking site use on well-being outcomes. It will include psychoeducation regarding the potential negative impacts of highly visual social networking site use on mental health outcomes and an introduction to thought challenging techniques. The video will then provide examples of some negative thoughts that may be triggered by highly visual social networking site use and examples of how to challenge these via socratic questioning. A summary of general helpful coping statements will also be provided. During the video, participants will be asked to reflect on and record the strategies that may be most useful for them. The intervention will be administered once.

The video has been designed and narrated by the primary researcher and specifically designed for this study. Participants will be requested to watch the video and take related tasks (i.e. questionnaires and brief interactive learning tasks) via a zoom meeting to ensure compliance with study protocol.
Intervention code [1] 323825 0
Prevention
Intervention code [2] 324133 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331747 0
Acceptability and feasibility.
Acceptability will be measured after watching the video via quantitative questions (Likert scale) asking participants about their level of satisfaction with the video components. Three qualitative open-ended questions will also be asked to seek additional information regarding intervention suggested improvements.
Timepoint [1] 331747 0
Outcome measures will be assessed immediately following the intervention.
Secondary outcome [1] 411001 0
Frequency of negative automatic thoughts will be assessed using the Automatic thoughts questionnaire-negative (ATQ)',
Timepoint [1] 411001 0
Immediately prior to and following intervention. Follow-up data will also be taken 1-week post-intervention.
Secondary outcome [2] 412327 0
Body image will be measured by 3 visual analogue scales.
Timepoint [2] 412327 0
Will be assessed immediately prior to and following the intervention. Follow-up data will also be taken 1-week post-intervention.
Secondary outcome [3] 412328 0
Well-being (emotional).
Emotional well-being will be assessed via the Positive and Negative Affect Scales - short scale (PANAS).
Timepoint [3] 412328 0
Outcome measures will be assessed prior to and immediately following intervention video. Follow-up data will also be taken 1-week post-intervention.
Secondary outcome [4] 412383 0
Believability of negative automatic thoughts will be assessed using the Automatic Thoughts Questionnaire – Believability (ATQ-B-15),
Timepoint [4] 412383 0
Immediately prior to and after intervention, in addition to 1-week following.
Secondary outcome [5] 412384 0
Cognitive well-being will be assessed via the Satisfaction With Life Scale (SWLS).
Timepoint [5] 412384 0
Immediately prior to and post- intervention. Follow-up data will also be obtained 1-week after intervention.

Eligibility
Key inclusion criteria
Have had an Instagram account for at least 1 week prior to experiment and access to a smartphone providing access to that Instagram account on the day of the experiment. Must be fluent in English and over the age of 16 years.
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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



Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/08/2022
Actual
18/08/2022
Date of last participant enrolment
Anticipated
31/10/2022
Actual
1/02/2023
Date of last data collection
Anticipated
7/11/2022
Actual
2/02/2023
Sample size
Target
36
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311470 0
University
Name [1] 311470 0
University of Adelaide
Country [1] 311470 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace, Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 312868 0
None
Name [1] 312868 0
n/a
Address [1] 312868 0
n/a
Country [1] 312868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310938 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 310938 0
North Terrace, Adelaide SA 5005
Ethics committee country [1] 310938 0
Australia
Date submitted for ethics approval [1] 310938 0
26/07/2022
Approval date [1] 310938 0
27/07/2022
Ethics approval number [1] 310938 0
22/73

Summary
Brief summary
Despite the increasing recognition of the negative impacts of HVSNS use on mental health outcomes, there is a paucity of research focused on possible interventions to reduce such negative outcomes. The current study is an extension of the review already completed as part of the project, that mapped the literature to date focusing on such interventions and that identified gaps in the literature. As outlined in that review, much of the existing research in this area has adopted exposure reduction or abstinence strategies, with mixed findings, and a need for other easily accessible psychology-informed treatment programs. The current project aims to fill the gap identified in the literature by developing an easily accessible, time and cost-effective solution through a CBT-based online micro-intervention designed to ameliorate the negative impacts of online highly visual social networking site (HVSNS) use on well-being outcomes.

The proposed research aims to evaluate the acceptability of the CBT-based micro-intervention video. The current project also aims to assess the feasibility of recruiting, retaining and collecting outcome data in a university population. Secondary objectives will be to undertake a preliminary assessment of the potential impact of the program on reducing the negative impact of mental health outcomes. Through this study, the acceptability of the program and feasibility of a larger study will be assessed. The current study will also provide valuable information provide required information about sample size required for any larger studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119422 0
Ms Zoe Herriman
Address 119422 0
The University of Adelaide
North Terrace
Adelaide SA 5005
Country 119422 0
Australia
Phone 119422 0
+61413328533
Fax 119422 0
Email 119422 0
zoe.herriman@adelaide.edu.au
Contact person for public queries
Name 119423 0
Ms Zoe Herriman
Address 119423 0
The University of Adelaide
North Terrace
Adelaide SA 5005
Country 119423 0
Australia
Phone 119423 0
+61413328533
Fax 119423 0
Email 119423 0
zoe.herriman@adelaide.edu.au
Contact person for scientific queries
Name 119424 0
Ms Zoe Herriman
Address 119424 0
The University of Adelaide
North Terrace
Adelaide SA 5005
Country 119424 0
Australia
Phone 119424 0
+61413328533
Fax 119424 0
Email 119424 0
zoe.herriman@adelaide.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?
All of the individual participant data collected during the trial will be shared, after de-identification.
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, Assoc. Prof. Rachel Roberts - rachel.roberts@adelaide.edu.au


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.