Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001301459
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
13/11/2025
Date registered
Help: Date registered
21/11/2025
Date last updated
Help: Date last updated
21/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
21/11/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Tailored Cognitive Bias Modification of Interpretations Intervention for Adolescents with Anxiety
Scientific title
Evaluation of a Tailored Cognitive Bias Modification of Interpretations Intervention for Adolescents with Anxiety
Additional trial identifiers [1] 315634 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Anxiety 339702 0
Condition category
Condition code
Mental Health 335951 335951 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This project aims to evaluate user engagement, acceptability, and efficacy of a cognitive bias modification of interpretations (CBM-I) intervention for adolescents aged 14 to 17 years old with anxiety symptoms. The trial is a single-arm pilot trial design – all participants will receive the intervention. We aim to evaluate efficacy by comparing baseline and post-intervention outcomes. The study will also collect data associated with user engagement (e.g., attrition) and use of the intervention (e.g., number of sessions completed).

Participants will receive CBM-I intervention delivered in an online format via the Qualtrics platform. It will involve reading through brief psychoeducation information on unhealthy and healthy thinking habits, before moving on to complete 8, 10-15 minute sequential sessions four times per week over two to four weeks. Each session will comprise of 3 practice scenarios, followed by maximum 30 intervention scenarios, drawn from a larger bank of scenarios. The entire intervention will comprise maximum 240 intervention scenarios in total. On completion of a session, the next session is only available for completion on the following day. Scenario content will be relevant to domains of generalised anxiety, social anxiety, and panic disorder.

The intervention is designed to encourage positive or benign interpretations of ambiguous situations and is based on the word fragment paradigm used in previous CBM-I studies and members of the project team. Participants will be asked to imagine scenarios as happening to themselves as vividly as possible. During every trial, participants will be presented with a short 2-3 sentence scenario describing an uncertain situation that might happen to them, with the final word of each scenario missing to create ambiguity (e.g., “You messaged your friend yesterday asking about their day. Your friend has “seen” the message but hasn’t replied.”). This is followed by a word fragment that would disambiguate the sentence in a neutral or positive manner (“They must be b_sy”). Participants are required to input the correct letter to complete the word fragment, and this is followed by a simple yes/no comprehension question (“Is your friend ignoring you because they’re upset with you?”). The ratio of yes/no responses to the comprehension question will be equal across the intervention. Non-negative interpretations are positively reinforced (“That’s right! Your friend is really busy and hasn’t had time to respond to your text yet.”).

Unique to this study, scenarios will be tailored to participants concerns in both relevancy and content-specificity ( to GAD/SAD/Panic Disorder). At the start of each CBM-I session, adolescents will be provided a list of topics to choose from (e.g., ‘Academics/School, ‘Health, Injury, Illness’, ‘Future Planning’, ‘Performance in social situations’). Session content will be comprised of scenarios designed to target biases specific to anxiety subtypes of participants (i.e., generalised anxiety, social anxiety, and panic disorder). Participants will be shown a random selection of unique scenarios based on their selection of module/topic.

Participants will receive a weekly reminder email to complete their sessions for that week.
Intervention code [1] 332526 0
Behaviour
Intervention code [2] 332618 0
Treatment: Other
Description of the comparator or control
This is a single arm pilot trial with no comparator/control treatment arm. All participants recruited to this trial will receive the intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 343473 0
The first primary outcome is user engagement.
Timepoint [1] 343473 0
This data will be continuously collected throughout the study.
Primary outcome [2] 343474 0
The second primary outcome is digital program satisfaction.
Timepoint [2] 343474 0
This questionnaire will be completed at post-intervention, immediately upon completion of final session. .
Primary outcome [3] 343475 0
The second primary outcome is barriers to digital program use.
Timepoint [3] 343475 0
This questionnaire will be completed at post-intervention, immediately upon completion of final session.
Secondary outcome [1] 454504 0
The first secondary outcome is anxiety and depressive symptoms.
Timepoint [1] 454504 0
This questionnaire will be administered at post-intervention, immediately upon completion of final session.
Secondary outcome [2] 454505 0
The second secondary outcome is the extent of daily life interference due to anxiety symptoms.
Timepoint [2] 454505 0
This will be administered at baseline and at post-intervention (immediately upon completion of final session).
Secondary outcome [3] 454506 0
The third secondary outcome is interpretation bias.
Timepoint [3] 454506 0
This will be administered at baseline and at post-intervention (immediately upon completion of final session).
Secondary outcome [4] 454928 0
The fourth primary outcome is subjective user experience of the intervention.
Timepoint [4] 454928 0
This measure will be optional – during the post-intervention questionnaire (immediately after completion of the intervention) participants will be offered the opportunity to engage in a brief (5-15 minute) phone call. Contingent on scheduling, the call will be organised to occur as soon as possible.

Eligibility
Key inclusion criteria
Key inclusion criteria
1. Aged between 14 to 17 years old (self-report).
2. Located in Australia (self-report and geographic location as reported by Qualtrics).
3. Must experience elevated anxiety symptoms, as determined by:
a. Meeting clinical cut-off on the RCADS on the social anxiety subscale and/or generalised anxiety subscale and/or separation anxiety subscale, AND;
b. above cut-off for the overall anxiety score.
4. Adolescent is fluent in English and can independently read and answer questions in English at Grade 7 level (to ensure comprehension of content).
5. Own or have access to an internet-enabled device.
6. If participant is 14-15 years of age, they must be assessed to be a “mature minor” (I.e., determined to be Gillick competent as per Gillick competency test).
7. Must provide contact details (mobile number and email address) of a parent/caregiver.
Minimum age
14 Years
Maximum age
17 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Experiencing life-threatening suicidal ideation and/or had serious suicidal ideation in the last month.
2. Have a diagnosis of an organic brain injury, psychosis, severe developmental disability, vision impairment, or physical disability that would prevent them using a computer.
3. Participants will be immediately withdrawn from the study upon a parent opting out on their behalf.
4. If participants only meet the RCADS overall anxiety clinical cutoff due to elevated scores on the OCD subscale and/or Separation anxiety subscale.
5. Fail to satisfy any of the inclusion criteria.

All inclusion and exclusion criteria will be assessed through a self-report online eligibility screener hosted on the study website. Excluded participants will be provided with a generic message and details of child mental health services and other trusted mental health organisations.

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/12/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 320235 0
University
Name [1] 320235 0
University of New South Wales
Country [1] 320235 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 323136 0
None
Name [1] 323136 0
Address [1] 323136 0
Country [1] 323136 0
Other collaborator category [1] 283753 0
Other Collaborative groups
Name [1] 283753 0
Black Dog Institute
Address [1] 283753 0
Country [1] 283753 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318778 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 318778 0
Ethics committee country [1] 318778 0
Australia
Date submitted for ethics approval [1] 318778 0
11/03/2025
Approval date [1] 318778 0
16/07/2025
Ethics approval number [1] 318778 0

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

Contacts
Principal investigator
Name 145230 0
Prof Jennifer L. Hudson
Address 145230 0
Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 145230 0
Australia
Phone 145230 0
+61 2 9065 9251
Fax 145230 0
Email 145230 0
[email protected]
Contact person for public queries
Name 145231 0
Jessica Wang
Address 145231 0
UNSW Sydney, Mathews Building, F23 Library Walk, Kensington NSW 2033
Country 145231 0
Australia
Phone 145231 0
+61 435439590
Fax 145231 0
Email 145231 0
[email protected]
Contact person for scientific queries
Name 145232 0
Jessica Wang
Address 145232 0
UNSW Sydney, Mathews Building, F23 Library Walk, Kensington NSW 2033
Country 145232 0
Australia
Phone 145232 0
+61 435439590
Fax 145232 0
Email 145232 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.