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Completed

NCT Number: NCT04535778

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

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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Key information

Conditions

Treatment of Illness-related Distress in Physical LTCs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Psychology Section

London, SE1 9RT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

COMPASS

Behavioral

An 11 module, therapist-supported online CBT program.

Standard charity resources

Behavioral

Resources provided by the charities involved, including supportive listening, online support groups, information resources and local community support groups.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Crohn's & Colitis UK
  • Kidney Care UK
  • National Multiple Sclerosis Society
  • Psoriasis Association
  • Shift.ms

Registry information

Official study title

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

Acronym: COMPASS

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 2, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.