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Trial registered on ANZCTR


Registration number
ACTRN12624001317583
Ethics application status
Approved
Date submitted
9/10/2024
Date registered
30/10/2024
Date last updated
30/10/2024
Date data sharing statement initially provided
30/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of an internationally-available, self-guided, online psychological program for adults with chronic physical health conditions
Scientific title
The Chronic Conditions Course: Exploring the efficacy of an international self-guided online psychological program for adults with chronic physical health conditions
Secondary ID [1] 313098 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 335341 0
cardiovascular diseases 335342 0
Multiple sclerosis 335548 0
Osteoarthritis 335549 0
Inflammatory Bowel Disease 335550 0
Asthma 335551 0
Chronic Obstructive Pulmonary Disease (COPD) 335552 0
Chronic Kidney Disease 335553 0
Chronic Liver Diseases 335554 0
Neurological conditions 335555 0
Oral and gastrointestinal diseases 335556 0
Metabolic and endocrine diseases 335557 0
Various Chronic Physical Health Conditions 335558 0
Rheumatoid Arthritis 335602 0
Psoriasis 335603 0
Condition category
Condition code
Mental Health 331932 331932 0 0
Anxiety
Mental Health 331933 331933 0 0
Depression
Cancer 332118 332118 0 0
Any cancer
Blood 332119 332119 0 0
Haematological diseases
Cardiovascular 332120 332120 0 0
Hypertension
Infection 332121 332121 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Inflammatory and Immune System 332122 332122 0 0
Autoimmune diseases
Musculoskeletal 332128 332128 0 0
Osteoarthritis
Metabolic and Endocrine 332129 332129 0 0
Diabetes
Oral and Gastrointestinal 332130 332130 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this randomised controlled trial, all participants will receive access to an 8 week internet-delivered, self-management course, the Chronic Conditions Course, which provides good information and skills for managing the impacts of chronic conditions on people's emotional wellbeing and quality of life. The Chronic Conditions Course runs for 8 weeks and consists of:

(a) 5 online lessons (in the form of presentation slides) with exercises for learning the information and skills. The duration of each lesson is approximately 20 to 30 minutes. Lessons are completed in weeks 1, 2, 4, 5 and 7. Lessons can be viewed in the online platform, or downloaded as PDF files. Lessons are accompanied by lesson worksheets which can be downloaded and/or printed as PDF files. Participants are encouraged to engage with the home-based exercises at a frequency and duration that is helpful for them, though a suggested time commitment of at least 30 minutes each week is encouraged. The first lesson (in week 1) is a introduction and overview of the course, including psycho-education about chronic health conditions and emotional wellbeing. Participants are encouraged to identify their symptoms (e.g. thinking styles, physical symptoms, unhelpful habits) as a home-based exercise. Lesson 2 (week 2) introduces cognitive challenging skills, and participants are encouraged to practice thought challenging in the following two weeks. Lesson 3 (week 4) covers behavioural activation and relaxation strategies to manage mood and anxiety symptoms, and participants are provided with the resources to undertake activity scheduling as a home-based task. Lesson 4 (week 5) introduces activity pacing to manage symptoms such as pain and fatigue, and graded exposure to manage anxiety and avoidance. Following lesson 4, participants are encouraged to attempt activity pacing and/or graded exposure tasks as a home-based exercise. Finally, Lesson 5 (week 7) includes information and strategies relating to relapse prevention, and participants are given materials to help with goal-setting for the future, and also a relapse prevention plan.
(b) Automatic emails that help guide people through the course with frequency of once or twice per week. Examples of these e-mails include; reminders when new lessons are available, congratulatory messages once a lesson has been completed, brief messages that reinforce the core concepts of the lessons, and e-mails inviting contact and encouraging engagement if a participant has not logged in for a while.
(c) Additional Resources (articles in PDF format) developed specifically for this study. These resources provide information about different problems people often struggle with, including managing sleep, working with health professionals, etc.
(d) Case Stories and examples based on previous participants. These case stories are briefly incorporated into each lesson, commonly in the form of worked examples on worksheets, or participants' experiences learning and practicing the skills within the lesson. Additional case stories are example as optional materials that can be accessed by participants at their own discretion, which provide more in-depth information and experiences.

Participants in this research trial will be randomly allocated to an Active Treatment Group or a Waitlist Control Group. Participants in the Active Treatment Group will receive full access to the Chronic Conditions Course. The Waitlist Control Group will receive the same treatment after the Active Treatment Group has completed the 8-week Course.
Adherence with the intervention is monitored via the study's secure web platform, which records information such as; the number of participant log-ins, lesson completions; time spent completing each lesson; and number of downloads of additional resources.
Intervention code [1] 329659 0
Behaviour
Intervention code [2] 329660 0
Treatment: Other
Comparator / control treatment
Participants in this research trial will be randomly allocated to an Active Treatment Group or a Waitlist Control Group. The Waitlist Control Group will receive the treatment after the Active Treatment Group has completed the 8-week Course.
Control group
Active

Outcomes
Primary outcome [1] 339530 0
Depression symptoms
Timepoint [1] 339530 0
Application, Pre-treatment (Week 0), Week 2, Mid-treatment (Week 4), Week 6, and Post-treatment (Week 8).
Primary timepoint: Post-Treatment (Week 8)
Primary outcome [2] 339534 0
Anxiety symptoms
Timepoint [2] 339534 0
Application, Pre-treatment (Week 0), Week 2, Mid-treatment (Week 4), Week 6, and Post-treatment (Week 8).
Primary timepoint: Post-Treatment (Week 8)
Primary outcome [3] 339535 0
Health and disability
Timepoint [3] 339535 0
Application, Pre-treatment (Week 0), Week 2, Mid-treatment (Week 4), Week 6, and Post-treatment (Week 8).
Primary timepoint: Post-Treatment (Week 8)
Secondary outcome [1] 440357 0
Somatic symptoms
Timepoint [1] 440357 0
Application, Pre-treatment (Week 0), and Post-treatment (Week 8)
Secondary outcome [2] 440498 0
Pain severity
Timepoint [2] 440498 0
Application, Pre-treatment (Week 0), and Post-treatment (Week 8)
Secondary outcome [3] 440499 0
Fatigue severity
Timepoint [3] 440499 0
Application, Pre-treatment (Week 0), and Post-treatment (Week 8)
Secondary outcome [4] 440500 0
Working alliance
Timepoint [4] 440500 0
Application, Pre-treatment, Week 2, Mid-treatment (Week 4), Week 6, and Post-treatment (Week 8).
Secondary outcome [5] 440501 0
Expectations
Timepoint [5] 440501 0
Application, Pre-treatment, Week 2, Mid-treatment (Week 4), Week 6, and Post-treatment (Week 8).
Secondary outcome [6] 440502 0
Remoralisation
Timepoint [6] 440502 0
Application, Pre-treatment, Week 2, Mid-treatment (Week 4), Week 6, and Post-treatment (Week 8).
Secondary outcome [7] 440503 0
Insight
Timepoint [7] 440503 0
Application, Pre-treatment, Week 2, Mid-treatment (Week 4), Week 6, and Post-treatment (Week 8).
Secondary outcome [8] 440952 0
Satisfaction
Timepoint [8] 440952 0
Post-Treatment (Week 8)

Eligibility
Key inclusion criteria
1. Have a diagnosed chronic physical health condition
2. Chronic health condition is impacting their mental health (self-reported)
3. Are aged 18 years or older
4. Is living outside of Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Self-reported risk of suicide
2. Unable to read and understand English

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). 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
With alpha set at 0.05, power set at 0.80 and a sample size of 176, the study is powered to enable the detection of small-to-moderate effect size (i.e., Cohen’s d > 0.30 differences in symptoms of anxiety, depression and disability at each time point. However, more participants are being recruited to enable exploratory analyses to examine the prediction and moderation of clinical response in subgroups of participants (e.g., patients with specific conditions, patient’s characteristics and attitudes to treatment).

Subgroup analyses be utilised to assess change in the clinical outcomes from baseline to post-treatment for certain, of interest, subgroups. For example, sub-group analyses will assess treatment effects for participants with baseline levels of anxiety, depression and disability within the clinical ranges separately from the overall sample. Clinical levels of baseline symptoms will be based on the published literature e.g., depression (PHQ-9>9), anxiety (GAD-7 >9) and disability levels (WHODAS within the 25th, 50th, and 75th percentiles). All analyses will be carried out using conservative intention-to-treat principles and using generalised equation (GEE) models to handle missing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
28/09/2029
Actual
Date of last data collection
Anticipated
1/12/2029
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 26602 0
New Zealand
State/province [1] 26602 0
Country [2] 26603 0
United States of America
State/province [2] 26603 0
Country [3] 26604 0
United Kingdom
State/province [3] 26604 0
Country [4] 26605 0
Canada
State/province [4] 26605 0
Country [5] 26606 0
Ireland
State/province [5] 26606 0
Country [6] 26607 0
Singapore
State/province [6] 26607 0
Country [7] 26608 0
South Africa
State/province [7] 26608 0

Funding & Sponsors
Funding source category [1] 317545 0
University
Name [1] 317545 0
Macquarie University
Country [1] 317545 0
Australia
Primary sponsor type
University
Name
Department of Psychology, Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 319849 0
None
Name [1] 319849 0
Address [1] 319849 0
Country [1] 319849 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316256 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 316256 0
https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics
Ethics committee country [1] 316256 0
Australia
Date submitted for ethics approval [1] 316256 0
Approval date [1] 316256 0
26/09/2024
Ethics approval number [1] 316256 0
520241790459147

Summary
Brief summary
The current research project aims to examine the efficacy and acceptability of an online psychological treatment for common mental health symptoms (e.g. depression and anxiety) to adults living outside of Australia with chronic physical health conditions (Chronic Conditions Course) in a self-directed format. Additionally, it also aims to explore predictors of treatment response in an online psychological treatment that is provided in a self-directed format. It is predicted that the self-directed online treatment will be efficacious and acceptable to reduce common mental health symptoms for adults with chronic health conditions.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137302 0
Prof Blake Dear
Address 137302 0
Department of Psychology Macquarie University North Ryde NSW 2109
Country 137302 0
Australia
Phone 137302 0
+61 2 9850 9979
Fax 137302 0
Email 137302 0
[email protected]
Contact person for public queries
Name 137303 0
Blake Dear
Address 137303 0
Department of Psychology Macquarie University North Ryde NSW 2109
Country 137303 0
Australia
Phone 137303 0
+61 2 9850 9979
Fax 137303 0
Email 137303 0
[email protected]
Contact person for scientific queries
Name 137304 0
Blake Dear
Address 137304 0
Department of Psychology Macquarie University North Ryde NSW 2109
Country 137304 0
Australia
Phone 137304 0
+61 2 9850 9979
Fax 137304 0
Email 137304 0
[email protected]

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 ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24255Study protocol  [email protected]
24256Informed consent form  [email protected]
24257Ethical approval  [email protected]
24258Analytic code  [email protected]
24259Statistical analysis plan  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.