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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)

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ClinicalTrials.gov Identifier: NCT04535778
Recruitment Status : Completed
First Posted : September 2, 2020
Last Update Posted : March 31, 2022
Sponsor:
Collaborators:
National Multiple Sclerosis Society
Psoriasis Association
Crohn's & Colitis UK
Kidney Care UK
Shift.ms
Information provided by (Responsible Party):
King's College London

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 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.
Actual Study Start Date : November 16, 2020
Actual Primary Completion Date : July 1, 2021
Actual Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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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.

  4. Change in Patient Health Questionnaire - (PHQ-9) [ Time Frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) ]
    Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression

  5. Change in Generalised Anxiety Disorder scale (GAD-7) [ Time Frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) ]
    Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety

  6. Change in bespoke illness-related distress measure (2 items) [ Time Frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) ]
    Illness-related distress. Developed by research team. Min score = 0, Max score = 6, with higher scores indicating greater distress.

  7. Change in Patient Activation Measure (PAM) short version (13 items). [ Time Frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) ]
    Assess knowledge and confidence in illness self-management. Min score = 0, max score = 100, with higher scores indicating greater levels of knowledge and confidence.

  8. The Patient Global Impression Scales of Severity (PGI-S) [ Time Frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy) ]
    Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity.

  9. The Patient Global Impression Scales of Improvement (PGI-I) [ Time Frame: 6 weeks (mid-therapy) and 12 weeks (end of therapy) ]
    Perceived symptom improvement. 1 item. Min = 0, Max = 6, with higher scores indicating greater perceived symptom deterioration.


Eligibility Criteria
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Information from the National Library of Medicine

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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.
Contacts and Locations
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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


Locations
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United Kingdom
Health Psychology Section
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
King's College London
National Multiple Sclerosis Society
Psoriasis Association
Crohn's & Colitis UK
Kidney Care UK
Shift.ms
Investigators
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Principal Investigator: Rona Moss-Morris King's College London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: March 31, 2022
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Clinical Study Report (CSR)
Access Criteria: The data will only be available on request.

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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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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases