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

NCT04535778 | Completed DMC

• 1 other identifier: 20347
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment of Illness-related Distress in Physical LTCs

Outcome Measures

Primary Outcomes (1)

• Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

  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.

  At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)

Secondary Outcomes (9)

• 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 Illness perception questionnaire - revised (IPQ-R), emotional subscale

  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 Generalised Anxiety Disorder scale (GAD-7)

  At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)

Study Arms (2)

COMPASS

EXPERIMENTAL

Participants will be treated with an online CBT program that is specifically tailored to illness-related distress in the context of long-term conditions. Participants will also have access to the standard charity resources.

Behavioral: COMPASS

Standard charity resources

ACTIVE COMPARATOR

Participants will be directed to the standard resources provided by the charities involved in the study.

Behavioral: Standard charity resources

Interventions

COMPASS BEHAVIORAL

An 11 module, therapist-supported online CBT program.

COMPASS

Standard charity resources BEHAVIORAL

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

Standard charity resources

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• National Multiple Sclerosis Society: collaborator
• Psoriasis Association: collaborator
• Crohn's & Colitis UK: collaborator
• Kidney Care UK: collaborator
• Shift.ms: collaborator

Study Sites (1)

Health Psychology Section

London, SE1 9RT, United Kingdom

Location

Related Publications (2)

• Picariello F, Hulme K, Seaton N, Hudson JL, Norton S, Wroe A, Moss-Morris R. A randomized controlled trial of a digital cognitive-behavioral therapy program (COMPASS) for managing depression and anxiety related to living with a long-term physical health condition. Psychol Med. 2024 Jun;54(8):1796-1809. doi: 10.1017/S0033291723003756. Epub 2024 Feb 14.

  PMID: 38350600 DERIVED

• 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.

  PMID: 34697123 DERIVED

Study Officials

• Rona Moss-Morris

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: September 2, 2020
• Study Start: November 16, 2020
• Primary Completion: July 1, 2021
• Study Completion: January 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Access Criteria: The data will only be available on request.

Locations

GB (1)