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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04535778
Recruitment Status : Not yet recruiting
First Posted : September 2, 2020
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
MS Society
Diabetes UK
National Rheumatoid Arthritis Society (NRAS)
Kidney Care UK
Information provided by (Responsible Party):
King's College London

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: COMPASS
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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Katrin Hulme 020 7188 0179 katrin.hulme@kcl.ac.uk
Contact: Natasha Seaton 020 7188 2590 natasha.seaton@kcl.ac.uk

Locations
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United Kingdom
Health Psychology Section
London, United Kingdom, SE1 9RT
Contact: Natasha Seaton, Msc    0207 188 1189    natasha.seaton@kcl.ac.uk   
Sponsors and Collaborators
King's College London
MS Society
Diabetes UK
National Rheumatoid Arthritis Society (NRAS)
Kidney Care UK
Investigators
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Principal Investigator: Rona Moss-Morris King's College London
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04535778    
Other Study ID Numbers: 20347
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms