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

NCT07099365 | Completed

• 1 other identifier: 45014
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Depression, Anxiety; Chronic Disease

Keywords

anxiety; depression; psychological distress; chronic disease; cognitive behavioural therapy

Outcome Measures

Primary Outcomes (4)

• 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)

• 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

• 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)

Secondary Outcomes (13)

• App usability

  6 weeks (mid-study) and 12 weeks (end of study)

• Primary adherence and engagement: App usage data

  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

  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

  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

  At baseline, 6 weeks (mid-study) and 12 weeks (end of study)

Study Arms (2)

Orbi + Usual Charity Support (UCS)

EXPERIMENTAL

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

Usual Charity Support (UCS)

NO INTERVENTION

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.

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.

Orbi + Usual Charity Support (UCS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Avegen Health: collaborator

Study Sites (1)

Health Psychology Department, King's College London

London, London, SE1 9RT, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 35412516 BACKGROUND

• 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.

  PMID: 34697123 BACKGROUND

• 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.

  PMID: 38350600 BACKGROUND

• 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.

  PMID: 37563762 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Chronic Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rona Moss-Morris, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: June 10, 2025
• Primary Completion: June 1, 2026
• Study Completion: July 23, 2026
• Last Updated: August 7, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Access Criteria: The data will only be available on request.

Locations

GB (1)