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Evaluation of a Tailored Cognitive Bias Modification of Interpretations Intervention for Adolescents with Anxiety

Evaluation of a Tailored Cognitive Bias Modification of Interpretations Intervention for Adolescents with Anxiety

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001301459
Enrollment
38
Registered
2025-11-21
Start date
2025-12-08
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The current project is a single-arm pilot trial which aims to evaluate user engagement, feasibility, and acceptability of a tailored digital CBM-I intervention for adolescents who have elevated symptoms of generalised anxiety, social anxiety, and/or panic disorder, above a clinical threshold. An improved CBM-I program has been developed in consultation with adolescents and mental health professionals to maximise engagement and relevance of content and features for adolescents with anxiety. Adolescents aged 14-17 years who are reported to experience anxiety symptoms above a clinical cut-off on a self-report diagnostic measure are eligible to participate. User engagement will be assessed by objective usage data (i.e., number of sessions completed, participant dropout, time spent using program) as well as a questionnaire and semi-structured exit interview immediately post-intervention or at time of dropout. Changes in anxiety (and, secondarily, depressive symptoms) and life interference, and interpretation bias will be assessed before and after the intervention period.

Interventions

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 (

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.

Sponsors

University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
14 Years to 17 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026