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

Sponsor
King's College London
Study ID
NCT07099365
Status
Recruiting
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Conditions

  • Chronic Disease
  • Depression, Anxiety

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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. 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.

Study Details

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.

Key Dates

First listed
Aug 1, 2025
Start date
Jun 10, 2025
Status verified
Jan 2025
Primary completion
Mar 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Orbi + Usual Charity Support (UCS)
    Participants randomised to this condition receive access to a self-guided smartphone app (Orbi) based on cognitive behavioural therapy principles in addition to Usual Charity Support (Orbi + UCS) to support Psychological Adjustment in long-term physical conditions.
  • No Intervention: Usual Charity Support (UCS)
    Participants randomised to this condition access Usual Charity Support (UCS) for their long-term physical condition(s). Resources provided by the charities include supportive listening, online support groups, information resources and local community support groups.

Primary Outcome Measure

Recruitment [ Time Frame: At baseline ]

Central Contacts

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