Pilot RCT for COMPASS: an Online CBT Program Treating Anxiety and Low Mood in Long-term Conditions During the COVID-19 Pandemic.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- King's College London
- Enrollment
- 194
- Locations
- 2
- Primary Endpoint
- Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- Change in Illness perception questionnaire - revised (IPQ-R), emotional subscale(At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy))
- Change in Work and social adjustment scale (WSAS)(At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy))
- Change in EQ-5D-3L(At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy))
- Change in Generalised Anxiety Disorder scale (GAD-7)(At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy))
- Change in Patient Health Questionnaire - (PHQ-9)(At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy))
- Change in bespoke illness-related distress measure (2 items)(At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy))
- Change in Patient Activation Measure (PAM) short version (13 items).(At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy))
- The Patient Global Impression Scales of Improvement (PGI-I)(6 weeks (mid-therapy) and 12 weeks (end of therapy))
- The Patient Global Impression Scales of Severity (PGI-S)(At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy))