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

March 29, 2022 updated by: King's College London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Health Psychology Section

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COMPASS
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
An 11 module, therapist-supported online CBT program.
Active Comparator: Standard charity resources
Participants will be directed to the standard resources provided by the charities involved in the study.
Behavioral: Standard charity resources
Resources provided by the charities involved, including supportive listening, online support groups, information resources and local community support groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Work and social adjustment scale (WSAS)
Time Frame: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
Social functioning. Min score = 0, Max score = 40 , with higher scores indicating greater functional impairment.
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)
Quality of life. Min score = 5, Max score = 15 , with higher scores more problems in the scale dimensions.
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)
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.
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)
Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression
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)
Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety
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)
Illness-related distress. Developed by research team. Min score = 0, Max score = 6, with higher scores indicating greater distress.
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)
Assess knowledge and confidence in illness self-management. Min score = 0, max score = 100, with higher scores indicating greater levels of knowledge and confidence.
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)
Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity.
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)
Perceived symptom improvement. 1 item. Min = 0, Max = 6, with higher scores indicating greater perceived symptom deterioration.
6 weeks (mid-therapy) and 12 weeks (end of therapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

National Multiple Sclerosis Society
Psoriasis Association
Crohn's & Colitis UK
Kidney Care UK
Shift.ms

Investigators

  • Principal Investigator: Rona Moss-Morris, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20347

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Access Criteria

The data will only be available on request.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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