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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease; Depression, Anxiety
• Intervention / Treatment: Device: Orbi

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rona Moss-Morris, PhD; Phone Number: 0178 +44 (0)20 7188; Email: rona.moss-morris@kcl.ac.uk

Study Locations

• United Kingdom
  • London
    • London, London, United Kingdom, SE1 9RT
      • Recruiting
      • Health Psychology Department, King's College London
      • Contact: Rona Moss-Morris, PhD; Phone Number: 0178 +44 (0)20 7188; Email: rona.moss-morris@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged ≥18-years
• Verbal and written proficiency in English
• United Kingdom resident (General Practitioner registered)
• Basic computer literacy
• Email address to register with Orbi
• Have a long-term physical health condition
• Are experiencing distress related to their long-term physical condition

Exclusion Criteria:

• Evidence of substance dependency, cognitive impairment, severe mental health conditions identified by adhering to usual care Improving Access to Psychological Therapies (IAPT) screening practices that are employed at assessment and triage
• Those with evidence of severe depression and/ or anxiety scoring over 6 on the Patient Health Questionnaire-4 (PHQ-4) eligibility questionnaire or scoring 1 or above on the eligibility Patient Health Questionnaire-9 (PHQ-9) suicide risk question
• Receiving active psychological treatment from psychologist/counsellor/therapist or online psychological intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Orbi; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Frequencies and percentages of the number of potential participants recruited to the study	At baseline
Retention	Frequencies and percentages of the number of participants retained in the study	At baseline, 6 weeks (mid-study) and 12 weeks (end of study)
Acceptability	Quantitative: Frequencies and percentages or means and standard deviations of the Theoretical Framework of Acceptability (TFA) questionnaire Qualitative: Framework Thematic Analysis	6 weeks (mid-study) and 12 weeks (end of study)
Reach	Frequencies and percentages of recruited participants who are from under-represented ethnic groups for research conducted in the United Kingdom (e.g. ethnic groups other than white British)	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
App usability	Qualitative: Usability of the app will be evaluated within the interviews and Framework Thematic Analysis.	6 weeks (mid-study) and 12 weeks (end of study)
Primary adherence and engagement: App usage data	Frequencies and percentages or means and standard deviations of: Number of intervention sessions accessed and/or completed; time spent or time to completion, number of log-ins, pages viewed.	6 weeks (mid-study) and 12 weeks (end of study)
Compare post intervention scores on Work and Social Adjustment Scale (WSAS) adjusting for baseline differences between groups	A 5-item scale measuring the impact of mental health issues on daily functioning across work, home management, social leisure, private leisure, and close relationships. Each item is scored from 0 (no impairment) to 8 (severe impairment). Total score ranges from 0 to 40, with higher scores indicating greater functional impairment.	At baseline, 6 weeks (mid-study) and 12 weeks (end of study)
Compare post intervention scores on Patient Enablement Instrument (PEI) adjusting for baseline differences between groups	A 6-item questionnaire assessing patient enablement (i.e. patients' ability to understand and cope with their health and illness) on a 4-point scale (much better, better, same or less, not applicable). Total scores range from 0 to 12, with higher scores indicating greater patient enablement.	6 weeks (mid-study) and 12 weeks (end of study)
Compare post intervention scores on Patient Global Impression of Improvement (PGI-I) adjusting for baseline differences between groups	A one-item questionnaire assessing how patient's health condition has changed since the beginning of the study on a 7-point scale with scoring ranges from 0 to 6. Higher scores indicate greater deterioration.	6 weeks (mid-study) and 12 weeks (end of study)
Compare post intervention scores on Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS-15) adjusting for baseline differences between groups	A 15-item scale assessing symptoms of anxiety and depression. It includes items from the Patient Health Questionnaire Scale (PHQ-8) for depression and the Generalised Anxiety Disorder Scale (GAD-7) for anxiety, each scored on a 4-point Likert scale from 'not at all' (0) to 'nearly every day' (3). Total scores range from 0 to 45 with higher scores indicating greater symptom severity.	At baseline, 6 weeks (mid-study) and 12 weeks (end of study)
Compare post intervention scores on Patient Health Questionnaire Scale - (PHQ-8) adjusting for baseline differences between groups	8-item questionnaire scoring the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for depression on 4-point Likert scales from 'not at all' (0) to 'nearly every day' (3). Total scores below 5, 10, 15, 20, and up to 24 are categorised as none-to-minimal, mild, moderate, moderately severe, and severe depression.	At baseline, 6 weeks (mid-study) and 12 weeks (end of study)
Compare post intervention scores on Generalised Anxiety Disorder Scale (GAD-7) adjusting for baseline differences between groups	A 7-item questionnaire assessing the severity of generalised anxiety symptoms based on DSM-IV criteria. Each item is scored on a 4-point Likert scale from 'not at all' (0) to 'nearly every day' (3). Total scores range from 0 to 21, with cut-off points at 5, 10, and 15, indicating mild, moderate, and severe anxiety, respectively.	At baseline, 6 weeks (mid-study) and 12 weeks (end of study)
Compare post intervention scores on Illness Related Distress (IRD) scale adjusting for baseline differences between groups	A 14-item scale assessing how a long-term physical health condition has affected the psychological distress experienced by an individual over the last two weeks. Intrapersonal IRD = items 1-7 (cut-off = 15); Interpersonal IRD = items 8-14 (cut-off = 12). The scale is augmented by 3 additional items. Two horizontal visual analogue scales ranging from 0 to 10: One indicating the amount of psychological distress that is attributed to having one or more physical Long Term Condition (LTC) over the last two weeks; one indicating the severity of psychological distress related to the LTC over the last two weeks. The final item asks the respondent to specify which LTC they are attributing their psychological distress to (as many people are affected by multiple LTCs in parallel).	At baseline, 6 weeks (mid-study) and 12 weeks (end of study)
Compare post intervention scores on EuroQol 5-Dimension 3-Level Questionnaire (EQ-5D-3L) adjusting for baseline differences between groups	A 5-item scale measuring health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (1 to 3). Total score ranges from 5 to 15, with higher scores indicating more severe issues in health-related quality of life.	At baseline, 6 weeks (mid-study) and 12 weeks (end of study)
Compare post intervention scores on Patient Global Impression of Severity (PGI-S) adjusting for baseline differences between groups	A one-item questionnaire assessing perceived severity of participants' long-term physical conditions using a 4-point scale with scoring ranges from 0 to 3. Higher scores indicate greater severity.	At baseline, 6 weeks (mid-study) and 12 weeks (end of study)
Comparison between intervention and control groups on Health Service Utilisation	Usage of health services will be captured with the Health Service Use Questionnaire. Participants will indicate whether they have accessed key services, including general practitioner (GP), psychological or counselling services, and emergency care during the past 3 months. For each service reported, additional items capture (i) the number of contacts, (ii) the mode of contact (e.g., in-person, telephone, video), and (iii) the duration of the most recent contact.	At baseline, 6 weeks (mid-study) and 12 weeks (end of study)
Comparison between intervention and control in access of charity services	Participants will also be asked about their access of charity resources. A multiple-selection drop-down box will show the following options (charity helpline, online forums/networks/phone counselling, information booklets, others)	6 weeks (mid-study) and 12 weeks (end of study)

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Avegen Health
• Investigators: Principal Investigator: Rona Moss-Morris, PhD, King's College London

Publications and helpful links

General Publications

• Carroll S, Moon Z, Hudson J, Hulme K, Moss-Morris R. An Evidence-Based Theory of Psychological Adjustment to Long-Term Physical Health Conditions: Applications in Clinical Practice. Psychosom Med. 2022 Jun 1;84(5):547-559. doi: 10.1097/PSY.0000000000001076. Epub 2022 Apr 12.
• Hulme K, Hudson JL, Picariello F, Seaton N, Norton S, Wroe A, Moss-Morris R. Clinical efficacy of COMPASS, a digital cognitive-behavioural therapy programme for treating anxiety and depression in patients with long-term physical health conditions: a protocol for randomised controlled trial. BMJ Open. 2021 Oct 25;11(10):e053971. doi: 10.1136/bmjopen-2021-053971.
• Picariello F, Hulme K, Seaton N, Hudson JL, Norton S, Wroe A, Moss-Morris R. A randomized controlled trial of a digital cognitive-behavioral therapy program (COMPASS) for managing depression and anxiety related to living with a long-term physical health condition. Psychol Med. 2024 Jun;54(8):1796-1809. doi: 10.1017/S0033291723003756. Epub 2024 Feb 14.
• Seaton N, Moss-Morris R, Hulme K, Macaulay H, Hudson J. A cognitive-behavioural therapy programme for managing depression and anxiety in long-term physical health conditions: mixed-methods real-world evaluation of the COMPASS programme. BJPsych Open. 2023 Aug 11;9(5):e153. doi: 10.1192/bjo.2023.519.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: July 25, 2025
• First Submitted That Met QC Criteria: July 25, 2025
• First Posted (Actual): August 1, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: depression; anxiety; chronic disease; cognitive behavioural therapy; psychological distress
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Anxiety Disorders; Depression; Chronic Disease
• Other Study ID Numbers: 45014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study will be available on request from the corresponding author. The data will not be available publicly due to privacy or ethical restrictions.
• IPD Sharing Access Criteria: The data will only be available on request.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No