Overview
This study is a two-arm, randomised controlled cross-over feasibility study with a nested, optional qualitative study and nested, optional, non-invasive brain activity study. The intervention consists of a self-guided smartphone app (Orbi) based on cognitive behavioural therapy 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 (Hulme et al., 2021; Picariello et al., 2024). The control condition consists of usual charity (UCS) support for the relevant LTC(s). 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:
- Is Orbi a feasible and acceptable intervention for individuals experiencing psychological distress related to LTCs?
- Which aspects of the Orbi app and the trial enhance or diminish participants' experience?
Participants will:
- Be randomly assigned to receive Orbi + UCS or UCS alone in a 1:1 allocation ratio, 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.
- A subset of participants will be invited to take part in a nested, optional, non-invasive brain activity study to evaluate potential cognitive changes (e.g. attentional shifts).
Eligibility
Inclusion Criteria:
i. Aged ≥18-years ii. Verbal and written proficiency in English iii. UK resident (GP registered) iv. Basic computer literacy v. Email address to register with Orbi vi. Have a long-term physical health condition vii. Are experiencing distress related to their long-term physical condition
Exclusion Criteria:
i) Evidence of substance dependency, cognitive impairment, severe mental health conditions identified by adhering to usual care IAPT screening practices that are employed at assessment and triage ii) Those with evidence of severe depression and/ or anxiety scoring over 6 on the PHQ-4 eligibility questionnaire or scoring 1 or above on the eligibility PHQ-9 suicide risk question iii) Receiving active psychological treatment from psychologist/counsellor/therapist or online psychological intervention