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Depression, AnxietyPALNCT07099365

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

A study testing Orbi in people with Depression, Anxiety and Chronic Disease, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Anxiety, Chronic Disease
What is being tested?
Orbi
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited Kingdom
Study dates
10 Jun 2025to 23 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Health Psychology Department, King's College London

    London, London, SE1 9RT

Other trials in United Kingdom

About this study

Official title: 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:

Read more
  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.
Being tested
Orbi
Keywords
anxiety, depression, psychological distress, chronic disease, cognitive behavioural therapy
Medical subject headings
Depression, Anxiety Disorders, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrbiDevice

    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 groups in NCT07099365
Study groupRoleWhat they receive
Orbi + Usual Charity Support (UCS)ExperimentalParticipants 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.
Receives: Device: Orbi
Usual Charity Support (UCS)No interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment

    Frequencies and percentages of the number of potential participants recruited to the study

    Measured: At baseline

  2. Retention

    Frequencies and percentages of the number of participants retained in the study

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

  3. 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)

    Measured: At baseline

  4. Acceptability

    Quantitative: Frequencies and percentages or means and standard deviations of the Theoretical Framework of Acceptability (TFA) questionnaire

    Qualitative: Framework Thematic Analysis

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

Secondary outcomes (13)

  1. App usability

    Qualitative: Usability of the app will be evaluated within the interviews and Framework Thematic Analysis.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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).

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study start10 Jun 2025
  3. Primary completion1 Jun 2026
  4. Study completion23 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07099365
Sponsor's protocol ID
45014
Acronym
PAL
Status last verified
Jan 2025
First submitted
25 Jul 2025
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 35412516

  • 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.

    PubMed 34697123

  • 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.

    PubMed 38350600

  • 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.

    PubMed 37563762

Questions about this trial

What is this clinical trial studying?

A study testing Orbi in people with Depression, Anxiety and Chronic Disease, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07099365, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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