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

NCT04535778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

  • Treatment of Illness-related Distress in Physical LTCs

Interventions

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.

Sponsors & Collaborators

  • National Multiple Sclerosis Society

    collaborator OTHER
  • Psoriasis Association

    collaborator UNKNOWN
  • Crohn's & Colitis UK

    collaborator UNKNOWN
  • Kidney Care UK

    collaborator OTHER
  • Shift.ms

    collaborator UNKNOWN
  • King's College London

    lead OTHER

Principal Investigators

  • Rona Moss-Morris · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2021-07-01
Completion
2022-01-01

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04535778 on ClinicalTrials.gov