Clinical trial NCT04535778: COMPASS Study: an Online Cognitive-behavioural Therapy (CBT) Program Treating Anxiety and Low Mood in Long-term Conditions During the COVID-19 Pandemic
Official title: Pilot RCT for COMPASS: an Online CBT Program Treating Anxiety and Low Mood in Long-term Conditions During the COVID-19 Pandemic.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment of Illness-related Distress in Physical LTCs
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
name: Psoriasis Association
name: Crohn's & Colitis UK
name: Kidney Care UK
name: Shift.ms
First posted: 2020-09-02
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
timeFrame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Secondary outcomes:
measure: Change in Work and social adjustment scale (WSAS)
timeFrame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
measure: Change in EQ-5D-3L
timeFrame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
measure: Change in Illness perception questionnaire - revised (IPQ-R), emotional subscale
timeFrame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
measure: Change in Patient Health Questionnaire - (PHQ-9)
timeFrame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
measure: Change in Generalised Anxiety Disorder scale (GAD-7)
timeFrame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
measure: Change in bespoke illness-related distress measure (2 items)
timeFrame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
measure: Change in Patient Activation Measure (PAM) short version (13 items).
timeFrame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
measure: The Patient Global Impression Scales of Severity (PGI-S)
timeFrame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
measure: The Patient Global Impression Scales of Improvement (PGI-I)
timeFrame: 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Health Psychology Section
Study officials:
affiliation: King's College London
name: Rona Moss-Morris
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hulme K, Hudson JL, Picariello F, Seaton N, Norton S, Wroe A, Moss-Morris R. Clinical efficacy of COMPASS, a digital cognitive-behavioural therapy programme for treating anxiety and depression in patients with long-term physical health conditions: a protocol for randomised controlled trial. BMJ Open. 2021 Oct 25;11(10):e053971. doi: 10.1136/bmjopen-2021-053971.