RecruitingNot ApplicableNCT07099365

Psychological Adjustment to Long-term (PAL) Physical Conditions: A Randomised Cross-over Feasibility Trial of a Self-guided App

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


Sponsor

King's College London

Enrollment

60 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a self-guided smartphone app called Orbi for people in the UK who are living with a long-term physical health condition (such as diabetes, heart disease, or chronic pain) and are experiencing emotional distress as a result. The app provides psychological support through evidence-based techniques and is compared to a waitlist control in a crossover design. **You may be eligible if...** - You are 18 or older - You live in the UK and are registered with a GP - You have a long-term physical health condition - You are experiencing emotional distress related to your health condition - You have basic computer skills and an email address - You have verbal and written proficiency in English **You may NOT be eligible if...** - You have severe depression or anxiety (PHQ-4 score above 6 or any score on the suicide risk question) - You have a substance dependency, cognitive impairment, or severe mental health condition - You are currently receiving active psychological treatment (therapy, counselling, or another online program) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOrbi

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. Orbi is made up of 13 topics, each exploring a different challenge faced by individuals with a LTC(s). Orbi is a self-guided CBT programme with no therapist involvement.


Locations(1)

Health Psychology Department, King's College London

London, London, United Kingdom

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NCT07099365


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