At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Orbi (device)
- How long the study runs
- Study runs about 13 months (dates as stated)
- About the drug or intervention
- Orbi — device: Orbi is adapted from COMPASS, a web-based cognitive behavioural therapy (CBT) intervention based on the Transdiagnostic Model of Adjustment in Long-Term (physical) Conditions Model.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 58
- Started
- 2025-06-10
- Last checked
- 2025-01
Plain English Summary
What is this study?
- • Testing a new treatment for depression, anxiety
- • NA - 58 participants
- • This study is a two-arm, randomised controlled cross-over feasibility study with a nested, optional qualitative study
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with depression, anxiety
Where?
- • London - Health Psychology Department, King's College London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Aged ≥18-years
- ✓Verbal and written proficiency in English
- ✓United Kingdom resident (General Practitioner registered)
- ✓Basic computer literacy
- ✓Email address to register with Orbi
Who cannot take part
- ✗Receiving active psychological treatment from psychologist/counsellor/therapist or online psychological intervention
See the full criteria
Where Is This Study? (1 UK site)
Health Psychology Department, King's College London
London SE1 9RT, United Kingdom