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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2022-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Pilot and Feasibility Trial of a Group Mindfulness and Self-compassion Intervention for Young People Diagnosed With IBD

NCT04100239

Inflammatory Bowel Diseases

UNKNOWN NA

Evaluating a Single-session Mental Health Intervention for UK University Students

NCT05093816

Depression Anxiety Happiness

UNKNOWN NA

An Online Wellness Intervention for University Students

NCT05718141

Mental Health Wellness 1

COMPLETED NA

Connecting Breath and Mind for CYP With Long COVID

NCT05705154

Post-COVID-19 Syndrome Anxiety Breathlessness

UNKNOWN NA

On Top of Everything

NCT04610333

Mental Health Youth Mindfulness +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Treatment of Illness-related Distress in Physical LTCs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

COMPASS

Intervention Type BEHAVIORAL

An 11 module, therapist-supported online CBT program.

Standard charity resources

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

Group Type ACTIVE_COMPARATOR

Standard charity resources

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COMPASS

An 11 module, therapist-supported online CBT program.

Intervention Type BEHAVIORAL

Standard charity resources

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No