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

Completed
Treatment of Illness-related Distress in Physical LTCs

Behavioral: COMPASS

An 11 module, therapist-supported online CBT program.

Behavioral: Standard charity resources

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

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United Kingdom
Locations

Health Psychology Section
London, United Kingdom

Rona Moss-Morris, Principal Investigator
King's College London

King's College London
NCT Number
MeSH Terms
COVID-19