COMPASS Study: an Online Cognitive-behavioural Therapy (CBT) Program Treating Anxiety and Low Mood in Long-term Conditions During the COVID-19 Pandemic

Study Overview
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Brief Summary
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This study is a single-centre, interventional randomised controlled trial. Participants will be individually randomised to receive either COMPASS online CBT + usual care (standard LTC charity support), or usual care only. Randomisation will be stratified by recruiting charity site to ensure a balance of participants with different LTCs across the intervention and control arm. Randomisation will occur using a 1:1 allocation ratio managed by RECAP software. Participants randomised to COMPASS will receive access to the online program. It consists of 11 online modules which target challenges associated with living with LTC(s) and includes, amongst other things, psycho-education, patient examples, interactive tasks and goal setting. Participants are linked to a therapist; 'guide', who will provide 6 x 30 minute support sessions delivered fortnightly in the format preferred by the client (phone and/or in-site message). Participants allocated to the usual care control arm will receive the usual care that is available to them via their charity. All charities include a helpline which can be accessed via telephone or email. The helplines at all charities offer one-off emotional and/or informational support provided by people trained in active listening and/or counselling skills. Additional support avenues that can be accessed may include online support groups, local community support groups and informational resources.

Official Title
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Pilot RCT for COMPASS: an Online CBT Program Treating Anxiety and Low Mood in Long-term Conditions During the COVID-19 Pandemic.

Conditions
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Treatment of Illness-related Distress in Physical LTCs

Intervention / Treatment
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* Behavioral: COMPASS
* Behavioral: Standard charity resources


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 or over Have responded to sign posting advise from the LTC charity or responded to an advert placed on a LTC charity website expressing their interest in taking part in the study. Speak English to a sufficiently high standard to allow them to interact with digital CBT programs. Live in the UK and can provide contact details of their registered general practitioner Have an email address to allow them to register with a digital CBT program and have a basic understanding of the internet. Scores ≥3 on the shortened patient health questionnaire (PHQ-4) self-report measure of depression and anxiety in relation to their LTC and/or the COVID-19 pandemic. Exclusion Criteria: Evidence of alcohol and/or drug dependency, cognitive impairment, severe mental health disorders, including bipolar disorder or psychosis Acute suicidal risk requiring a level of support that cannot be provided by therapists who are supporting patients remotely in their use of digital health interventions. Receiving active psychological treatment. Active psychological treatment is defined as receiving treatment from a psychologist/counselor/therapist or engaging with other online psychological treatment interventions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COMPASS<br>Participants will be treated with an online CBT program that is specifically tailored to illness-related distress in the context of long-term conditions. Participants will also have access to the standard charity resources. | Behavioral: COMPASS<br>* An 11 module, therapist-supported online CBT program.<br>|
| Active Comparator: Standard charity resources<br>Participants will be directed to the standard resources provided by the charities involved in the study. | Behavioral: Standard charity resources<br>* Resources provided by the charities involved, including supportive listening, online support groups, information resources and local community support groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) | A composite measure of Generalised Anxiety Disorder questionnaire (GAD-7) and Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress. | At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Work and social adjustment scale (WSAS) | Social functioning. Min score = 0, Max score = 40 , with higher scores indicating greater functional impairment. | At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) | 
| Change in EQ-5D-3L | Quality of life. Min score = 5, Max score = 15 , with higher scores more problems in the scale dimensions. | At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) | 
| Change in Illness perception questionnaire - revised (IPQ-R), emotional subscale | IPQ-R tailored to COVID-19 to establish emotional responses regarding the COVID-19 pandemic. Min score = 0, Max score = 24 , with higher scores indicating higher emotional responses. | At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) | 
| Change in Patient Health Questionnaire - (PHQ-9) | Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression | At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) | 
| Change in Generalised Anxiety Disorder scale (GAD-7) | Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety | At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) | 
| Change in bespoke illness-related distress measure (2 items) | Illness-related distress. Developed by research team. Min score = 0, Max score = 6, with higher scores indicating greater distress. | At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) | 
| Change in Patient Activation Measure (PAM) short version (13 items). | Assess knowledge and confidence in illness self-management. Min score = 0, max score = 100, with higher scores indicating greater levels of knowledge and confidence. | At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) | 
| The Patient Global Impression Scales of Severity (PGI-S) | Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity. | At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) | 
| The Patient Global Impression Scales of Improvement (PGI-I) | Perceived symptom improvement. 1 item. Min = 0, Max = 6, with higher scores indicating greater perceived symptom deterioration. | 6 weeks (mid-therapy) and 12 weeks (end of therapy) |