Chronic Disease, Depression, Anxiety
Conditions
Keywords
anxiety, depression, psychological distress, chronic disease, cognitive behavioural therapy
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: 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.
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.
Sponsors
King's College London
Avegen Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | At baseline | Frequencies and percentages of the number of potential participants recruited to the study |
| Retention | At baseline, 6 weeks (mid-study) and 12 weeks (end of study) | Frequencies and percentages of the number of participants retained in the study |
| Reach | At baseline | 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) |
| Acceptability | 6 weeks (mid-study) and 12 weeks (end of study) | Quantitative: Frequencies and percentages or means and standard deviations of the Theoretical Framework of Acceptability (TFA) questionnaire Qualitative: Framework Thematic Analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| App usability | 6 weeks (mid-study) and 12 weeks (end of study) | Qualitative: Usability of the app will be evaluated within the interviews and Framework Thematic Analysis. |
| Primary adherence and engagement: App usage data | 6 weeks (mid-study) and 12 weeks (end of study) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| Compare post intervention scores on Illness Related Distress (IRD) scale adjusting for baseline differences between groups | At baseline, 6 weeks (mid-study) and 12 weeks (end of study) | 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). |
| Compare post intervention scores on Work and Social Adjustment Scale (WSAS) adjusting for baseline differences between groups | At baseline, 6 weeks (mid-study) and 12 weeks (end of study) | 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. |
| Compare post intervention scores on EuroQol 5-Dimension 3-Level Questionnaire (EQ-5D-3L) adjusting for baseline differences between groups | At baseline, 6 weeks (mid-study) and 12 weeks (end of study) | 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. |
| Compare post intervention scores on Patient Enablement Instrument (PEI) adjusting for baseline differences between groups | 6 weeks (mid-study) and 12 weeks (end of study) | 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. |
| Compare post intervention scores on Patient Global Impression of Severity (PGI-S) adjusting for baseline differences between groups | At baseline, 6 weeks (mid-study) and 12 weeks (end of study) | 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. |
| Compare post intervention scores on Patient Global Impression of Improvement (PGI-I) adjusting for baseline differences between groups | 6 weeks (mid-study) and 12 weeks (end of study) | 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. |
| Comparison between intervention and control groups on Health Service Utilisation | At baseline, 6 weeks (mid-study) and 12 weeks (end of study) | 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. |
| Comparison between intervention and control in access of charity services | 6 weeks (mid-study) and 12 weeks (end of study) | 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) |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORRona Moss-Morris, PhD
King's College London
Outcome results
None listed