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Evaluating CBT Bytesize: a mixed-methods feasibility trial of a blended digital CBT intervention for adolescent anxiety and low mood

Evaluating CBT Bytesize: a mixed-methods feasibility trial of a blended digital CBT intervention for adolescent anxiety and low mood

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17872625
Enrollment
50
Registered
2025-06-04
Start date
2021-12-21
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Anxiety disorders in children and young people Mental and Behavioural Disorders

Interventions

Current interventions as of 08/07/2025: The intervention group consisted of children and young people who voluntarily opted into the CBT Bitesize programme following identification from Healios’ ex

Sponsors

Manchester Metropolitan University
Lead Sponsor
Healios Ltd
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 08/07/2025: 1. Being referred to Healios by contracted NHS trusts supporting young people in the UK 2. Having anxiety symptoms/anxiety disorder(s) and low mood as the primary presentation(s). Young people with comorbidities were not excluded, as long as the primary presentation was ‘anxiety’. 3. Access to a smartphone and the Internet 4. Good level of conversational English 5. Aged 11 to 17 years 6. Willing to talk about their experiences and provide feedback on the CBT Bitesize programme _____ Previous inclusion criteria: 1. Children and young people (CYP) aged 8 to 17 years 2. Referred to a CAMHS (Child and Adolescent Mental Health Services) team for anxiety-related difficulties 3. Deemed clinically appropriate for brief cognitive-behavioural therapy (CBT) by their care team 4. Able to understand and communicate in English, sufficient to engage with the intervention and complete outcome measures 5. Have access to a device (e.g., smartphone, tablet, or computer) and the internet to engage with the digital content 6. Provided informed consent/assent (with parental/guardian consent as appropriate based on age and service policy)

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 08/07/2025: 1. Presence of sight/hearing problems 2. Suicide attempts within the last three months and/or actively suicidal 3. Current safeguarding concerns, safeguarding investigations or criminal investigations 4. Not able/willing to provide assent to take part in CBT Bytesize, or parents/legal guardians not providing consent to take part in the programme. _____ Previous exclusion criteria: 1. Primary presenting difficulties that are not anxiety-related (e.g., severe depression, eating disorders, trauma, or psychosis) and are not suitable for brief CBT. 2. Level of clinical complexity or risk (e.g., high self-harm or safeguarding concerns) that would require more intensive or specialist interventions. 3. Insufficient English proficiency to understand intervention content or complete outcome measures. 4. Significant cognitive impairments or learning difficulties that would prevent engagement with the app-based or self-guided content. 5. Lack of access to a digital device or the internet, preventing full participation in the hybrid model of care.

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 08/07/2025: 1. Symptoms of various anxiety disorders and low mood, measured using the Revised Child Anxiety and Depression Scale (RCADS) at baseline (T1), mid-intervention (T2) and post-intervention (T3). _____ Previous primary outcome measure: Symptoms of various anxiety disorders and low mood, measured using the Revised Child Anxiety and Depression Scale (RCADS) at baseline, post-intervention, and 6-month follow-up

Secondary

MeasureTime frame
Current secondary outcome measures as of 08/07/2025: 1. Psychological distress and functioning measured using the Young Person’s CORE (YP-CORE) at baseline (T1), mid-intervention (T2) and post-intervention (T3). 2. Feasibility, assessed through session attendance and completion rates over the intervention period. 3. Acceptability, evaluated post-intervention using qualitative interviews and satisfaction surveys with participants (young people) and therapists. _____ Previous secondary outcome measures: 1. Psychological distress and functioning measured using the Young Person’s CORE (YP-CORE) at baseline, post-intervention, and 6-month follow-up 2. Progress toward self-identified goals measured using the Goal-Based Outcomes (GBOs) at baseline, post-intervention, and 6-month follow-up 3. Feasibility assessed through session attendance and completion rates over the intervention period 4. Acceptability evaluated using qualitative interviews and satisfaction surveys with participants and therapists post-intervention

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactDaniela;Frank Di Basilio;Burbach

;

d.dibasilio@lancaster.ac.uk;+44 (0)7312255301;

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026