Orbi: a self-guided CBT smartphone app to support adjustment to long-term physical conditions
A Randomised Controlled Cross-over Feasibility Trial of a Self-guided Smartphone App to Support Psychological Adjustment in Long-term Physical Conditions Compared to Usual Charity Support
This trial will try a self-guided CBT-based smartphone app called Orbi to help adults in the UK who are experiencing anxiety or depression related to long-term physical health conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London, London) |
| Trial ID | NCT07099365 on ClinicalTrials.gov |
What this trial studies
This is a two-arm randomized cross-over feasibility trial, with an optional nested qualitative study, comparing the Orbi smartphone app against usual charity support for people with long-term physical conditions. Orbi is an app adaptation of the evidence-based COMPASS web intervention and delivers CBT-informed modules for psychological adjustment. Participants are randomized to receive Orbi or usual charity support first, then cross over to the other condition, while feasibility, acceptability and user experience are measured. The study excludes people with severe mental health issues, active psychological treatment, substance dependency, or high suicide risk and is limited to adults resident in the UK.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) living in the UK with a long-term physical health condition who are experiencing distress related to that condition, have basic computer literacy and an email address, are proficient in English, and are not currently receiving active psychological treatment or showing severe mental health risk on screening.
Not a fit: People with substance dependency, cognitive impairment, severe mental health conditions, a high suicide-risk screen, PHQ-4 scores over the eligibility threshold, or those already in active therapy are excluded and unlikely to benefit from this app within the trial.
Why it matters
Potential benefit: If successful, Orbi could provide an easy-to-access, on-demand CBT-based tool to reduce anxiety and depression related to long-term physical conditions.
How similar studies have performed: Web-based CBT programs such as COMPASS have shown benefit for psychological distress in long-term conditions, but smartphone app adaptations like Orbi are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥18-years * Verbal and written proficiency in English * United Kingdom resident (General Practitioner registered) * Basic computer literacy * Email address to register with Orbi * Have a long-term physical health condition * Are experiencing distress related to their long-term physical condition Exclusion Criteria: * Evidence of substance dependency, cognitive impairment, severe mental health conditions identified by adhering to usual care Improving Access to Psychological Therapies (IAPT) screening practices that are employed at assessment and triage * Those with evidence of severe depression and/ or anxiety scoring over 6 on the Patient Health Questionnaire-4 (PHQ-4) eligibility questionnaire or scoring 1 or above on the eligibility Patient Health Questionnaire-9 (PHQ-9) suicide risk question * Receiving active psychological treatment from psychologist/counsellor/therapist or online psychological intervention
Where this trial is running
London, London
- Health Psychology Department, King's College London — London, London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Rona Moss-Morris, PhD — King's College London
- Study coordinator: Rona Moss-Morris, PhD
- Email: rona.moss-morris@kcl.ac.uk
- Phone: +44 (0)20 7188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.