ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001214426

Ethics application status

Approved

Date submitted

29/08/2016

Date registered

1/09/2016

Date last updated

4/02/2021

Date data sharing statement initially provided

4/02/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

The Chronic Conditions Course: A Randomised Controlled Trial of an Online Treatment Program for Adults with Chronic Health Conditions

Scientific title

The Chronic Conditions Course: A Randomised Controlled Trial of an Online Treatment Program for Adults with Chronic Health Conditions

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Various chronic health conditions / diseases

Various mental health conditions

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention, the Chronic Conditions Course, is an internet-delivered self-management program, which consists of:

(a) 5 online lessons provided over 8 weeks.
(b) A homework summary with assignments for each lesson
(c) Additional written resources that can be downloaded and which include information about other important skills, such as assertiveness and communication skills and techniques for managing sleep difficulties.
(d) Case Stories and real-world examples based on previous participants, which they can follow throughout the Course.
(e) Weekly contact with a Psychologist via secure email or telephone.

Participants will be encouraged to complete a lesson every 10 days and to read through a summary of the lesson and complete some basic homework in the following 10 days. Participants will have the option of contacting a Psychologist by phone or email each week for support with working through the course; each eCentreClinic Psychologist receives 1 hour or more of weekly supervision from another eCentreClinic Psychologist in which all of their participants are reviewed; as per best-practice guidelines and eCentreClinic Policy.

The Chronic Conditions Course is based on cognitive behaviour therapy (CBT) principles and teaches evidence-based skills for managing the impacts of chronic health condition on day-to-day activities and overall mental health. Each lesson takes between 10 and 20 minutes to complete and it is suggested that participants read each lesson at least twice and spend approximately 4 hours, across the week, practicing the skills taught. Telephone calls will be limited to approximately 10 minutes per week; however, more time will be provided where clinically indicated. Adherence (e.g., logins, lesson completion, lesson views, time spent on course) will be monitored via the eCentreClinic software, which is used to provide the Chronic Conditions Course.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

A Treatment-As-Usual Waitlist Control group who begin the treatment immediately after the treatment groups complete the Course. Treatment-As-Usual comprises any treatments that participants obtain via the care of their regular health professionals and general engagement with the health system across the treatment period.

Control group

Active

Outcomes

Primary outcome [1]

World Health Organization Disability Assessment Schedule 2.0 12-Item (WHODAS-12). This is a measure that assesses health and disability, which is applicable to a variety of disability domains, including neurological, mental, and chronic physical conditions.

Timepoint [1]

Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment

Primary outcome [2]

Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.

Timepoint [2]

Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment

Primary outcome [3]

Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.

Timepoint [3]

Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment

Secondary outcome [1]

Satisfaction with Life Scale (SWLS), which is a measure of life satisfaction.

Timepoint [1]

pre-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment

Secondary outcome [2]

EQ-5D-5L, which measures health outcome and is used for cost-effectiveness analysis.

Timepoint [2]

Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment

Secondary outcome [3]

Service use questionnaire, measures health service utilisation

Timepoint [3]

Pre-treatment, post-treatment,3 month post-treatment, 12 months post-treatment.

Secondary outcome [4]

Treatment Satisfaction Questionnaire (TSQ), which is a purpose built measure to assess the acceptability of online treatment Courses and to measure participants’ satisfaction with treatment.

Timepoint [4]

Post-treatment

Eligibility

Key inclusion criteria

(a) Confirmed diagnosis of a chronic physical health condition;
(b) Self-report that the condition is affecting their emotional wellbeing and quality of life
(c) Aged 18 years or older;
(d) Living in Australia;

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

(a) Very severe depression (i.e., indicated by a score > 24 on the PHQ-9)
(b) Acutely suicidal or recent history of attempted suicide (i.e., last 12 months)
(c) Not being under the medical management of a doctor for their chronic health condition.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Participants apply online via the clinic's website (www.ecentreclinic.org.au). Successful applications are followed by a telephone interview to confirm suitability for the trial. Randomisation will occur prior to application and concealment occurs through the use of locked and concealed cells in a spreadsheet, which recruitment staff are required to open serially.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be randomized using a list generated prior to the study via a software program (www.random.org) using permuted block randomisation.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Primary analyses of symptom outcomes will carried out employing longitudinal Generalised Estimation Equation (GEE) modelling. Missing data will be imputed using GEE accounting for individuals initial scores across the outcomes and adherence. Health economic analyses will evaluated by examining the incremental differences in costs and QALYs between the groups using a seemingly-unrelated regression model, which takes into account the correlation between costs and QALYs. Uncertainty in the incremental cost-effectiveness ratio (ICER) will be estimated using non-parametric bootstrapping and decision uncertainty will be evaluated using the cost-effectiveness acceptability curve (CEAC), which represents the probability of the treatments being cost-effective over a range of willingness to pay thresholds per QALY.

Analyses will also be carried conducted accounting for the impact of treatment adherence on outcomes as well as the impact of pre-treatment symptom severity on clinical outcomes. Subgroup analyses are also expected to be carried out to explore the efficacy and acceptability of the intervention for participants with different chronic health conditions.

A total sample of n = 500 in the treatment and control groups will provide power > 0.80 to detect small but clinically meaningful between-group differences at the 3 and 12 month follow-up; however, n = 500 also provides power in the situation where increasing between group differences appear at the follow-up time points. Importantly, a sample of n = 98 is required to achieve statistical power of 0.8 at the 0.05 level of statistical significance where the true ratio of means is 1.0 and the sample finding lies within +/- 20%. A sample size of n = 64 per group is needed to detect an incremental difference corresponding to a Cohen d effect size of 0.5 in costs per QALY between the groups with power set to 0.8 at the p = 0.05 (two-tailed) level of statistical significance. No specific sample size calculation is possible for the exploratory analyses;; however, we note that the sample size planned will allow statistical power of > 0.80 for small-to-moderate standardized effect sizes.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

12/09/2016

Actual

26/09/2016

Date of last participant enrolment

Anticipated

Actual

1/07/2020

Date of last data collection

Anticipated

Actual

1/07/2020

Sample size

Target

500

Accrual to date

Final

707

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian National Health and Medical Research Council (NHMRC)

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Blake Dear

Address

Department of Psychology
Macquarie University
NSW 2109
Australia

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Macquarie University

Address [1]

Balaclava Road, North Ryde
NSW, 2109, Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Medical Sciences Human Research Ethics Committee

Ethics committee address [1]

Balaclava Road, North Ryde 
NSW, 2109, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/08/2016

Ethics approval number [1]

5201600560

Summary

Brief summary

The diagnosis of a chronic physical disease can present multiple and significant challenges. It frequently requires adjustment to new and changing circumstances, limitations and treatment regimens that can have a profound impact on all aspects of life. Reflecting this, there is significant comorbidity between chronic physical disease and mental health disorder, particularly anxiety and depressive disorders. Research shows that anxiety and depressive disorders are at least twice as common in people with chronic physical diseases. Chronic physical diseases are one of the strongest risk factors for anxiety and depression and anxiety and depression are some of the strongest modifiable risk factors for deteriorating physical health.

Psychological treatments teach patients the skills to understand and manage symptoms and to limit their impact on functional abilities and quality of life.More than sixty years of research has proven cognitive behaviour therapy (CBT) to be effective in treating anxiety and depression. There is strong evidence that suitably tailored CBT significantly reduces disability and improves mental health in adults with chronic physical diseases. 

Australian epidemiological studies indicate that fewer than 20% of Australians with anxiety and depression access any mental health treatment. Common barriers to treatment include direct and indirect costs, stigma, insufficient numbers of appropriately trained mental health professionals and the decreasing availability of specialist services outside of metropolitan areas. The organisation and limited resources of health services means that mental health is not routinely considered alongside the management of chronic physical disease. Primary health care providers desperately need somewhere they can refer large numbers of patients with the chronic physical diseases for effective mental health treatment. Thus, there is an urgent need for psychological treatments that are accessible, acceptable, efficacious and cost-effective.

The proposed project has three primary aims: (1) to evaluate the short-term and long-term clinical efficacy of a new internet-delivered and transdiagnostic psychological treatment, the Chronic Disease Course, in reducing disability and improving emotional wellbeing and quality of life among adults with different chronic physical diseases; (2) to evaluate the treatment cost per patient and the cost-effectiveness of the treatment over the short-term and long-term; and (3) to explore the demographic, disease and patient-related predictors and moderators of treatment response. 

The hypotheses include:

1. The treatment will result in significant improvements in mental health and improvements in quality of life and disability at the completion of treatment. 
2. The treatment will be cost-effective from the health services perspective at the common willingness-to-pay thresholds per Quality-Adjusted Life Year (QALY

Trial website

www.ecentreclinic.org

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Blake Dear

Address

Department of Psychology
Macquarie University
NSW 2109

Country

Australia

Phone

+61 2 9850 9979

Fax

blake.dear@mq.edu.au

Contact person for public queries

Name

Blake Dear

Address

Department of Psychology
Macquarie University
NSW 2109

Country

Australia

Phone

+61 2 9850 9979

Fax

blake.dear@mq.edu.au

Contact person for scientific queries

Name

Blake Dear

Address

Department of Psychology
Macquarie University
NSW 2109

Country

Australia

Phone

+61 2 9850 9979

Fax

blake.dear@mq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Any non-identifiable data necessary to verify the outcomes reported in any published reports by the research team.

When will data be available (start and end dates)?

Data will be made after any original reports have been published. There will be no end date to the availability.

Available to whom?

Researchers working with the approval and under the governance of a Human Research Ethics Committee.

Available for what types of analyses?

Any analyses required to verify the outcomes reported in published reports.

How or where can data be obtained?

Data will be made available following formal request to the chief investigator using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committee's involved. Data can be obtained by e-mailing the chief investigator (blake.dear@mq.edu.au)

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The Chronic Conditions Course: A Randomised Controlled Trial of an Internet-Delivered Transdiagnostic Psychological Intervention for People with Chronic Health Conditions.	2022	https://dx.doi.org/10.1159/000522530

N.B. These documents automatically identified may not have been verified by the study sponsor.

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