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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
| Psoriasis Association | UNKNOWN |
| Crohn's & Colitis UK | UNKNOWN |
| Kidney Care UK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMPASS | Experimental | 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. |
|
| Standard charity resources | Active Comparator | Participants will be directed to the standard resources provided by the charities involved in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMPASS | Behavioral | An 11 module, therapist-supported online CBT program. |
| |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rona Moss-Morris | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Psychology Section | London | SE1 9RT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38350600 | Derived | 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. | |
| 34697123 |
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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.
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The data will only be available on request.
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| OTHER |
| Shift.ms | UNKNOWN |
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| Standard charity resources |
| Behavioral |
Resources provided by the charities involved, including supportive listening, online support groups, information resources and local community support groups. |
|
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) |
| 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. |