Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000237684
Ethics application status
Approved
Date submitted
26/02/2023
Date registered
6/03/2023
Date last updated
5/05/2023
Date data sharing statement initially provided
6/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Content Specificity in Interpretation Training for Adults with Social Anxiety Symptoms
Scientific title
Effect of Content Specificity in Cognitive Bias Modification on Interpretation Bias for Adults with Social Anxiety Symptoms
Secondary ID [1] 309084 0
None
Universal Trial Number (UTN)
U1111-1289-0748
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social anxiety 329147 0
Condition category
Condition code
Mental Health 326127 326127 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to examine the content specificity of Cognitive Bias Modification of Interpretations (CBM-I), by examining whether fear-domain match leads to greater changes in bias and symptoms than fear-domain mismatch. The study will focus on training adults with elevated levels of social anxiety towards positive and/or non-threatening interpretations of ambiguous situations. Participants will be randomly assigned to training scenarios that are relevant to social anxiety (content specific), or training scenarios that are associated with an irrelevant fear domain (fear of heights; non content specific).

The intervention will be a single session of CBM-I. The CBM-I intervention is expected to take approximately 60 minutes. Participants allocated to the intervention group will receive the CBM-I intervention with training scenarios that are relevant to social anxiety. Participants allocated to the control group will receive the CBM-I intervention with training scenarios that are related to an irrelevant fear domain (fear of heights). Participants will complete the intervention on a computer in a lab at Macquarie University. The intervention will be delivered via computer, with no direct experimenter involvement. One of the researchers will supervise each session in case of participant distress.

During the single-session intervention, participants will be presented with 60 ambiguous scenarios. During every trial, participants will be presented with a short 2-3 sentence scenario describing an uncertain situation that might happen to them. A benign or positive interpretation of the scenario is induced by the participant completing a word fragment (by typing a missing letter) which disambiguates the sentence. Next, a comprehension question is posed to check their understanding. This also accentuates the benign or positive interpretation of the scenario. All participants in the intervention group will receive the same scenarios. All participants in the control group will receive the same scenarios. An example of an ambiguous social scenario is provided below:

Scenario: You are giving a presentation in class. Everyone is staring at you as you speak. They are staring at you because you sound

Word fragment: inter_sting (missing letter = e)

Comprehension question: Is everyone staring at you because you sound interesting? (correct answer = yes)
Intervention code [1] 325528 0
Behaviour
Comparator / control treatment
This study will compare CBM-I training that is content specific (intervention group), to CBM-I training that is not consent specific (control group). The control group in this study will complete a single-session of CBM-I training, utilising ambiguous scenarios that are about an irrelevant anxiety domain (fear of heights).
Control group
Active

Outcomes
Primary outcome [1] 333993 0
The first primary outcome is interpretation bias. Interpretation bias will be measured using the Interpretation Recognition Task (IREC-T).
Timepoint [1] 333993 0
Interpretation bias will be measured on the IREC-T immediately before (pre-training) and after (post-training) the single-session CBM-I intervention.
Secondary outcome [1] 418981 0
Social anxiety symptoms will be measured using two related scales. The first scale is the Social Interaction Anxiety Scale (SIAS). The SIAS measures social anxiety symptoms related to social interactions. The prompt for the scale will ask participants to answer as per their feelings/perspectives “right now” at each time point.
Timepoint [1] 418981 0
Social anxiety symptoms will be measured on the SIAS immediately before (pre-training) and after (post-training) the single-session CBM-I intervention.
Secondary outcome [2] 418982 0
Social anxiety symptoms will be measured using two related scales. The second scale is the Social Phobia Scale (SPS). The SPS measures social anxiety symptoms related to being observed or scrutinised during everyday situations. The prompt for the scale will ask participants to answer as per their feelings/perspectives “right now” at each time point.
Timepoint [2] 418982 0
Social anxiety symptoms will be measured on the SPS immediately before (pre-training) and after (post-training) the single-session CBM-I intervention.
Secondary outcome [3] 419225 0
The second secondary outcome is state anxiety, which will be measured using the anxiety-tension subscale of the Profile of Mood States (POMS-SF).
Timepoint [3] 419225 0
State anxiety will be measured on the POMS-SF immediately before (pre-training) and after (post-training) the single-session CBM-I intervention.

Eligibility
Key inclusion criteria
To be eligible for this study, participants will be required to meet the following criteria:
1) Aged 18 years and above
2) Fluent in English
3) Elevated symptoms of social anxiety (based on a cut off score on validated scales)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) No identified fear of heights

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)
Eligibility for inclusion in the trial will be determined automatically, based on participants' responses in the Qualtrics screener survey. The survey will determine eligibility based on answers to self-report questions. The Qualtrics survey will automatically score the self-report screening questions, and will only provide participants who meet the inclusion criteria with the code to enrol to participate in the study. Once participants elect to participate in the study, after the screening, participants will be randomly allocated (via computerised randomisation) to the intervention or control group. Given that determination of eligibility is conducted automatically by Qualtrics, and allocation is conducted via a computerised randomisation program, allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out using a computerised randomisation procedure.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To determine the efficacy of the training on each of the primary (interpretation bias) and secondary (state anxiety and social anxiety), three separate 2 (group 1 vs group 2) x2 (pre-training vs post-training) mixed factorial analysis of variance tests will be conducted. Due to multiple planned AVNOVAs, p-values will be Bonferroni corrected for analysis.
Missing values are expected to be minimal due to the single-session design. In the case of missing values, if at least 80% of the scales were completed, means will be imputed for missing items.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2023
Actual
22/03/2023
Date of last participant enrolment
Anticipated
30/09/2023
Actual
3/05/2023
Date of last data collection
Anticipated
30/09/2023
Actual
3/05/2023
Sample size
Target
110
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313287 0
University
Name [1] 313287 0
Macquarie University
Country [1] 313287 0
Australia
Primary sponsor type
Individual
Name
Emily Daniel
Address
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 315027 0
Individual
Name [1] 315027 0
Dr Carly Johnco
Address [1] 315027 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country [1] 315027 0
Australia
Other collaborator category [1] 282570 0
Individual
Name [1] 282570 0
Dr Gemma Sicouri
Address [1] 282570 0
Black Dog Institute, Hospital Road, Prince of Wales Hospital,
Randwick NSW 2031
Country [1] 282570 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312517 0
Macquarie University - Human Research Ethics Committie
Ethics committee address [1] 312517 0
Ethics committee country [1] 312517 0
Australia
Date submitted for ethics approval [1] 312517 0
30/10/2022
Approval date [1] 312517 0
13/12/2022
Ethics approval number [1] 312517 0

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

Contacts
Principal investigator
Name 124942 0
Dr Carly Johnco
Address 124942 0
Macquarie University - Balaclava Rd, Macquarie Park NSW 2109
Country 124942 0
Australia
Phone 124942 0
+61 2 9850 8053
Fax 124942 0
Email 124942 0
[email protected]
Contact person for public queries
Name 124943 0
Emily Daniel
Address 124943 0
Macquarie University - Balaclava Rd, Macquarie Park NSW 2109
Country 124943 0
Australia
Phone 124943 0
+61 2 9065 9163
Fax 124943 0
Email 124943 0
[email protected]
Contact person for scientific queries
Name 124944 0
Emily Daniel
Address 124944 0
Macquarie University - Balaclava Rd, Macquarie Park NSW 2109
Country 124944 0
Australia
Phone 124944 0
+61 2 9065 9163
Fax 124944 0
Email 124944 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


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.