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Trial registered on ANZCTR


Registration number
ACTRN12620000969965
Ethics application status
Approved
Date submitted
1/07/2020
Date registered
28/09/2020
Date last updated
28/09/2020
Date data sharing statement initially provided
28/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Chronic Conditions Course: A Phase III randomised controlled trial of an online psychological program for adults with chronic physical health conditions
Scientific title
The Chronic Conditions Course: A Phase III randomised controlled trial of an online psychological program for adults with chronic physical health conditions
Secondary ID [1] 301660 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
The current study is a separate, large-scale replication of the Chronic Conditions Course (ACTRN12616001214426)

Health condition
Health condition(s) or problem(s) studied:
Various chronic health conditions 318090 0
Various mental health conditions 318091 0
Condition category
Condition code
Mental Health 316117 316117 0 0
Anxiety
Mental Health 316119 316119 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, the Chronic Conditions Course, is an internet-delivered self-management program. It runs for 8 weeks and consists of:

(a) 5 online lessons 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. 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 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 will also have the option of support from a psychologist as they work through the course, either via telephone or secure personal messaging. All psychologists will be nationally registered and employed by Macquarie University or one of its entities (e.g., MQ Health). All psychologists will be provided with training and supervision from a senior psychologist to ensure competence and safety in their practice. 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] 317973 0
Behaviour
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] 324310 0
Patient Health Questionnaire - 9 (PHQ-9), which is a self-report measure of depressive symptomatology
Timepoint [1] 324310 0
Application, pre-treatment, mid-treatment, post-treatment (primary endpoint), 3-months post-treatment, 12-months post-treatment, 24 months post-treatment
Primary outcome [2] 324311 0
Generalised Anxiety Disorder - 7 (GAD-7), which is a self-report meaure of anxiety symptomatology
Timepoint [2] 324311 0
Application, pre-treatment, mid-treatment, post-treatment (primary endpoint), 3-months post-treatment, 12-months post-treatment, 24 months post-treatment
Primary outcome [3] 324312 0
World Health Organization Disability Assessment Schedule 2.0 12-Item (WHODAS-12). This is a measure that assesses health and disability.
Timepoint [3] 324312 0
Application, pre-treatment, mid-treatment, post-treatment (primary endpoint), 3-months post-treatment, 12-months post-treatment, 24 months post-treatment
Secondary outcome [1] 384283 0
Five Wellbeing Index (WHO-5). This is a brief, widely used, measure of positive mental health.
Timepoint [1] 384283 0
Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment, 24 months post-treatment
Secondary outcome [2] 384284 0
PROMIS 10 (PROMIS-10), This is a 10 item scale designed to measure overall physical and mental health.
Timepoint [2] 384284 0
Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment, 24 months post-treatment
Secondary outcome [3] 384285 0
The PROMIS Sleep Disturbance Scale (PROMIS-SD-8). This is a brief 8-item measure of sleep difficulties.
Timepoint [3] 384285 0
Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment, 24 months post-treatment
Secondary outcome [4] 384286 0
De Jong Gierveld Loneliness Scale (DLS). This is a brief, widely used, measure of loneliness
Timepoint [4] 384286 0
Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment, 24 months post-treatment
Secondary outcome [5] 384306 0
Difficulties with Emotional Regulation Short Form (DERS-SF). This is a 18 item scale which is widely used to measure difficulties with emotion regulation.
Timepoint [5] 384306 0
Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment, 24 months post-treatment
Secondary outcome [6] 384307 0
Social Re-adjustment Scale (SRS). This is a brief checklist of significant life events, which people can endorse as occurring.
Timepoint [6] 384307 0
Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment, 24 months post-treatment
Secondary outcome [7] 384308 0
Brief Illness Perception Questionnaire (BIPQ). This is a brief, widely used, measure of common beliefs about a person’s physical illness, disease or condition
Timepoint [7] 384308 0
Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment, 24 months post-treatment
Secondary outcome [8] 384309 0
Treatment Satisfaction Questionnaires (TSQ). This is a purpose built measure to assess the acceptability of online treatment Courses and to measure participants’ satisfaction with treatment.
Timepoint [8] 384309 0
Application, pre-treatment, mid-treatment, post-treatment, 3-months post-treatment, 12-months post-treatment, 24 months post-treatment

Eligibility
Key inclusion criteria
a) diagnosed with a chronic physical health condition
b) aged 18 or older
c) self-reported impact of chronic health condition on mental health
d) living in Australia
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) imminently suicidal or unable to keep themselves safe
b) does not have access to a computer or the internet
c) unable to read or 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). 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
The study is powered to enable the detection of small-to-large effect size (i.e., Cohen’s d > 0.25) differences in 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).

Subgroup analyses be utilised to assess change in the clinical outcomes for certain 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306094 0
Government body
Name [1] 306094 0
Australian National Health and Medical Research Council (NHMRC)
Address [1] 306094 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 306094 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road, North Ryde
NSW, 2109, Australia
Country
Australia
Secondary sponsor category [1] 306870 0
None
Name [1] 306870 0
Address [1] 306870 0
Country [1] 306870 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306314 0
Macquarie University Medical Sciences Human Research Ethics Committee
Ethics committee address [1] 306314 0
Balaclava Road, North Ryde
NSW, 2109, Australia
Ethics committee country [1] 306314 0
Australia
Date submitted for ethics approval [1] 306314 0
13/02/2020
Approval date [1] 306314 0
03/03/2020
Ethics approval number [1] 306314 0
6357

Summary
Brief summary


The Chronic Conditions Course is a remotely-delivered psychological treatment that has been designed on the principles of cognitive behavioural therapy. It is designed for adults with a chronic health condition and associated impact on their emotional wellbeing. It involves five lessons and other additional materials delivered online over an 8 week period. Participants also receive telephone support from trained psychologists.

The efficacy of the Chronic Conditions Course has been examined in a randomised controlled trial, with promising results (long-term follow-up data collection is ongoing). The aim of our study is to evaluate the efficacy of the course in a larger group of participants. We hypothesise that, compared to a delayed treatment waitlist group, participants in the Chronic Conditions Course will report greater symptom improvements (in terms of mood, anxiety and level of disability). By recruiting a large group of participants, we are also aiming to understand what particular groups of people (or what participant characteristics) may benefit most from the Chronic Conditions Course.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103474 0
A/Prof Blake Dear
Address 103474 0
Department of Psychology
Macquarie University
NSW 2109
Country 103474 0
Australia
Phone 103474 0
+61 2 9850 9979
Fax 103474 0
Email 103474 0
blake.dear@mq.edu.au
Contact person for public queries
Name 103475 0
A/Prof Blake Dear
Address 103475 0
Department of Psychology
Macquarie University
NSW 2109
Country 103475 0
Australia
Phone 103475 0
+61 2 9850 9979
Fax 103475 0
Email 103475 0
blake.dear@mq.edu.au
Contact person for scientific queries
Name 103476 0
A/Prof Blake Dear
Address 103476 0
Department of Psychology
Macquarie University
NSW 2109
Country 103476 0
Australia
Phone 103476 0
+61 2 9850 9979
Fax 103476 0
Email 103476 0
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 other documents available
Summary results
No Results