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Orbi / Depression, Anxiety / Chronic Disease · Interventional Study
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered feasibility cross-over trial of a smartphone app (Orbi) based on CBT principles for psychological distress in long-term physical conditions, compared to usual charity support. The study has completed recruitment of 58 participants and measures feasibility, retention, reach, and acceptability over a 24-week period (12 weeks per arm), but results are not yet posted in this registry record.
Interventional, Randomized, Crossover, Single masking, Supportive Care purpose. Depression, Anxiety, Chronic Disease; age from 18 Years. Intervention: Orbi + Usual Charity Support (UCS). Compared with: Usual Charity Support (UCS) — No Intervention. n = 58. 1 site: United Kingdom.
This is a registered feasibility cross-over trial of a smartphone app (Orbi) based on CBT principles for psychological distress in long-term physical conditions, compared to usual charity support. The study has completed recruitment of 58 participants and measures feasibility, retention, reach, and acceptability over a 24-week period (12 weeks per arm), but results are not yet posted in this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This feasibility study will inform the design and conduct of a future definitive trial and cannot guide clinical practice pending results. Clinicians should await outcome data on acceptability and retention before considering Orbi for patient recommendations.
This is a feasibility trial registration with recruitment completed but no results posted; it measures feasibility and acceptability endpoints rather than clinical outcomes.
As stated by the source record.
Quoted from the source exactly as published.
This feasibility study will inform the design and conduct of a future definitive trial and cannot guide clinical practice pending results. Clinicians should await outcome data on acceptability and retention before considering Orbi for patient recommendations.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07099365). This is a study registration, not published results. Lead sponsor: King's College London. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 58 participants (ACTUAL). Conditions: Depression, Anxiety, Chronic Disease. Interventions: DEVICE: Orbi. Primary outcome measures: Recruitment , At baseline; Retention , At baseline, 6 weeks (mid-study) and 12 weeks (end of study); Reach , At baseline; Acceptability , 6 weeks (mid-study) and 12 weeks (end of study). Brief summary: This study is a two-arm, randomised controlled cross-over feasibility study with a nested, optional qualitative study. The intervention consists of a self-guided smartphone app (Orbi) based on cognitive behavioural therapy (CBT) principles, which is designed to support psychological adjustment in long-term physical conditions. Orbi is an app adaption of an existing, evidence-based web-based intervention COMPASS. The control condition consists of usual charity support (UCS) for the relevant long-term physical health conditions (LTCs). All charity support includes a helpline which can be accessed via telephone or email. The goal of this trial is to evaluate the feasibility of Orbi and the main questions it aims to answer are: 1. Is Orbi a feasible and acceptable intervention for individuals experiencing psychological distress related to LTCs? 2. Which aspects of the Orbi app and the trial enhance or diminish participants' experiences? Participants will: * Be randomised and each participant has an equal (50 %) chance of being assigned either to the Orbi+UCS group or to UCS group alone for 12 weeks. After 12 weeks, they will be crossed over to the alternate condition for another 12 weeks * Complete questionnaires to assess psychological distress and intervention engagement at baseline, 6 weeks, and 12 weeks. * A subset of participants will be invited to take part in a nested, optional semi-structured interviews to explore their experiences using Orbi and participating in the study.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.