ANZCTR - Registration

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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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

social media use

depression

Condition category

Condition code

Mental Health

Depression

Public Health

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]

Prevention

Intervention code [2]

Behaviour

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Outcome measures will be assessed immediately following the intervention.

Secondary outcome [1]

Frequency of negative automatic thoughts will be assessed using the Automatic thoughts questionnaire-negative (ATQ)',

Timepoint [1]

Immediately prior to and following intervention. Follow-up data will also be taken 1-week post-intervention.

Secondary outcome [2]

Body image will be measured by 3 visual analogue scales.

Timepoint [2]

Will be assessed immediately prior to and following the intervention. Follow-up data will also be taken 1-week post-intervention.

Secondary outcome [3]

Well-being (emotional).
Emotional well-being will be assessed via the Positive and Negative Affect Scales - short scale (PANAS).

Timepoint [3]

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]

Believability of negative automatic thoughts will be assessed using the Automatic Thoughts Questionnaire – Believability (ATQ-B-15),

Timepoint [4]

Immediately prior to and after intervention, in addition to 1-week following.

Secondary outcome [5]

Cognitive well-being will be assessed via the Satisfaction With Life Scale (SWLS).

Timepoint [5]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Adelaide

Address [1]

North Terrace, Adelaide SA 5005

Country [1]

Australia

Primary sponsor type

University

Name

University of Adelaide

Address

North Terrace, Adelaide SA 5005

Country

Australia

Secondary sponsor category [1]

None

Name [1]

n/a

Address [1]

n/a

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Adelaide Human Research Ethics Committee

Ethics committee address [1]

North Terrace, Adelaide SA 5005

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/07/2022

Approval date [1]

27/07/2022

Ethics approval number [1]

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

Ms Zoe Herriman

Address

The University of Adelaide
North Terrace
Adelaide SA 5005

Country

Australia

Phone

+61413328533

Fax

zoe.herriman@adelaide.edu.au

Contact person for public queries

Name

Zoe Herriman

Address

The University of Adelaide
North Terrace
Adelaide SA 5005

Country

Australia

Phone

+61413328533

Fax

zoe.herriman@adelaide.edu.au

Contact person for scientific queries

Name

Zoe Herriman

Address

The University of Adelaide
North Terrace
Adelaide SA 5005

Country

Australia

Phone

+61413328533

Fax

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.

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