COMPASS Study: an Online Cognitive-behavioural Therapy (CBT) Program Treating Anxiety and Low Mood in Long-term Conditions During the COVID-19 Pandemic (COMPASS)
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|ClinicalTrials.gov Identifier: NCT04535778|
Recruitment Status : Not yet recruiting
First Posted : September 2, 2020
Last Update Posted : September 2, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Treatment of Illness-related Distress in Physical LTCs||Behavioral: COMPASS Behavioral: Standard charity resources||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Pilot RCT for COMPASS: an Online CBT Program Treating Anxiety and Low Mood in Long-term Conditions During the COVID-19 Pandemic.|
|Estimated Study Start Date :||September 28, 2020|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
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.
An 11 module, therapist-supported online CBT program.
Active Comparator: Standard charity resources
Participants will be directed to the standard resources provided by the charities involved in the study.
Behavioral: Standard charity resources
Resources provided by the charities involved, including supportive listening, online support groups, information resources and local community support groups.
- Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) [ Time Frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) ]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.
- Change in Work and social adjustment scale (WSAS) [ Time Frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) ]Social functioning. Min score = 0, Max score = 40 , with higher scores indicating greater functional impairment.
- Change in EQ-5D-3L [ Time Frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) ]Quality of life. Min score = 5, Max score = 15 , with higher scores more problems in the scale dimensions.
- Change in Illness perception questionnaire - revised (IPQ-R), emotional subscale [ Time Frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535778
|Contact: Katrin Hulme||020 7188 firstname.lastname@example.org|
|Contact: Natasha Seaton||020 7188 email@example.com|
|Health Psychology Section|
|London, United Kingdom, SE1 9RT|
|Contact: Natasha Seaton, Msc 0207 188 1189 firstname.lastname@example.org|
|Principal Investigator:||Rona Moss-Morris||King's College London|