Treatment of Illness-related Distress in Physical LTCsCOMPASSNCT04535778

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

A study testing COMPASS and Standard charity resources in people with Treatment of Illness-related Distress in Physical LTCs, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Treatment of Illness-related Distress in Physical LTCs
What is being tested?: COMPASS and Standard charity resources
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 194 participants
Where: 1 siteUnited Kingdom
Study dates: 16 Nov 2020to 1 Jan 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Health Psychology Section
London, SE1 9RT

Other trials in United Kingdom

About this study

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

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
Being tested: COMPASS, Standard charity resources

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COMPASSBehavioural
An 11 module, therapist-supported online CBT program.
Standard charity resourcesBehavioural
Resources provided by the charities involved, including supportive listening, online support groups, information resources and local community support groups.

Study groups in NCT04535778
Study group	Role	What they receive
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. Receives: Behavioral: COMPASS
Standard charity resources	Active comparator	Participants will be directed to the standard resources provided by the charities involved in the study. Receives: Behavioral: Standard charity resources

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

Change in Work and social adjustment scale (WSAS)
Social functioning. Min score = 0, Max score = 40 , with higher scores indicating greater functional impairment.
Measured: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in EQ-5D-3L
Quality of life. Min score = 5, Max score = 15 , with higher scores more problems in the scale dimensions.
Measured: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in Illness perception questionnaire - revised (IPQ-R), emotional subscale
IPQ-R tailored to COVID-19 to establish emotional responses regarding the COVID-19 pandemic. Min score = 0, Max score = 24 , with higher scores indicating higher emotional responses.
Measured: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in Patient Health Questionnaire - (PHQ-9)
Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression
Measured: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in Generalised Anxiety Disorder scale (GAD-7)
Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety
Measured: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in bespoke illness-related distress measure (2 items)
Illness-related distress. Developed by research team. Min score = 0, Max score = 6, with higher scores indicating greater distress.
Measured: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in Patient Activation Measure (PAM) short version (13 items).
Assess knowledge and confidence in illness self-management. Min score = 0, max score = 100, with higher scores indicating greater levels of knowledge and confidence.
Measured: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
The Patient Global Impression Scales of Severity (PGI-S)
Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity.
Measured: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
The Patient Global Impression Scales of Improvement (PGI-I)
Perceived symptom improvement. 1 item. Min = 0, Max = 6, with higher scores indicating greater perceived symptom deterioration.
Measured: 6 weeks (mid-therapy) and 12 weeks (end of therapy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 20201 Jan 2022

First posted2 Sep 2020
Study start16 Nov 2020
Primary completion1 Jul 2021
Study completion1 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Treatment of Illness-related Distress in Physical LTCsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 194 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04535778
Sponsor's protocol ID: 20347
Acronym: COMPASS
Status last verified: Feb 2021
First submitted: 12 Aug 2020
Last updated: 31 Mar 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data that support the findings of this study will be available on request from the corresponding author. The data will not be available publicly due to privacy or ethical restrictions.

Publications

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.
PubMed 38350600
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.
PubMed 34697123

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot RCT for COMPASS: an Online CBT Program Treating Anxiety and Low Mood in Long-term Conditions During the COVID-19 Pandemic.
ClinicalTrials.gov ID: NCT04535778
Acronym / sponsor ID: COMPASS / 20347
Conditions: Treatment of Illness-related Distress in Physical LTCs
Study type: Interventional
Recruitment status: Completed
Enrolment: 194 participants (actual)
Lead sponsor: King's College LondonUniversity, hospital or other
Collaborators: National Multiple Sclerosis Society, Psoriasis Association, Crohn's & Colitis UK, Kidney Care UK, Shift.ms
Study start: 16 Nov 2020 (actual)
Primary completion: 1 Jul 2021 (actual)
Study completion: 1 Jan 2022 (actual)
First posted: 2 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is a single-centre, interventional randomised controlled trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
COMPASS	Experimental	Behavioral: COMPASSParticipants 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.
Standard charity resources	Active comparator	Behavioral: Standard charity resourcesParticipants will be directed to the standard resources provided by the charities involved in the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (3 listed)

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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COMPASSAn 11 module, therapist-supported online CBT program.	Behavioural	COMPASS
Standard charity resourcesResources provided by the charities involved, including supportive listening, online support groups, information resources and local community support groups.	Behavioural	Standard charity resources

Primary outcome

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.

9 secondary outcomes

Change in Work and social adjustment scale (WSAS)
Time frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in EQ-5D-3L
Time frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in Illness perception questionnaire - revised (IPQ-R), emotional subscale
Time frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in Patient Health Questionnaire - (PHQ-9)
Time frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in Generalised Anxiety Disorder scale (GAD-7)
Time frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in bespoke illness-related distress measure (2 items)
Time frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Change in Patient Activation Measure (PAM) short version (13 items).
Time frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
The Patient Global Impression Scales of Severity (PGI-S)
Time frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
The Patient Global Impression Scales of Improvement (PGI-I)
Time frame: 6 weeks (mid-therapy) and 12 weeks (end of therapy)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Derived from this study: PubMed 38350600Picariello 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.
Derived from this study: PubMed 34697123Hulme 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.
Individual participant dataSharing planned: Yes. The data that support the findings of this study will be available on request from the corresponding author. The data will not be available publicly due to privacy or ethical restrictions.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rona Moss-Morris principal investigator

King's College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing COMPASS and Standard charity resources in people with Treatment of Illness-related Distress in Physical LTCs, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04535778, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.