Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000634976
Ethics application status
Approved
Date submitted
26/05/2020
Date registered
29/05/2020
Date last updated
22/01/2021
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing an Online Coping Skills Intervention for People Living with Chronic Illness During the Covid-19 Pandemic
Scientific title
Testing an Online Coping Skills Intervention on Depression, Anxiety, and Stress in People Living with Chronic Illness During the Covid-19 Pandemic
Secondary ID [1] 301367 0
None
Universal Trial Number (UTN)
U1111-1252-5637
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic illness 317605 0
mental health 317606 0
depression 317607 0
stress 317608 0
anxiety 317609 0
Condition category
Condition code
Mental Health 315683 315683 0 0
Anxiety
Mental Health 315684 315684 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed study is a pilot randomized controlled trial with a wait-list control group. The study will investigate the effect of a brief one-week online intervention on depression, anxiety, and stress among adults living with chronic illness during the COVID-19 pandemic in New Zealand. This study is designed according to the CONSORT guidelines.
Forty-six participants will be recruited from online communities (e.g., Facebook support groups, organisation mailing lists) by an advertisement/flyer with a link to the intervention website. Participants will be encouraged to snowball recruit, i.e. to send the recruitment link to people they know who might be eligible for this study.
Interested participants will be requested to click on a link on the intervention website which takes them to REDCap (a secure research website) (Harris et al., 2019; Harris et al., 2009) for the purposes of providing online consent and filling out baseline questionnaires. This page will allow participants to read and download the Participant Information Sheet, complete online consent, and complete the baseline questionnaires once they have consented. Once participants have consented and completed the baseline questionnaire they will be randomised into either the waitlist group or the intervention group.
The waitlist group will receive an email stating that they will receive further information in 4-weeks’ time. The intervention group will receive an email containing the link for the intervention and the password to access it. Intervention group participants will then be asked to access this website each day for seven days. This will take approximately 20 minutes each day. Throughout this week, they will receive 2 emails or texts reminding them to complete the intervention. Three weeks after the intervention (4 weeks from completing the baseline questionnaire) participants in the intervention group will receive an email with a link to the follow-up questionnaire on REDCap (Harris et al., 2019; Harris et al., 2009) to complete. In contrast, the waitlist group will receive an email stating that they are in the waitlist group. They will be asked to continue with their usual care for the next 4 weeks, after which they will receive an email with a link to complete the follow-up questionnaire on REDCap. After completing this follow-up questionnaire they will then receive the link and password to the intervention and be asked to access this website each day for seven days. Four weeks after completing the first follow up questionnaire (8 weeks from completing the baseline questionnaire), participants in the waitlist group will receive an email with a link to the final follow-up questionnaire to complete on REDCap.
The study website will contain the Participant Information Sheet and the link to consent and sign up for the study, acknowledgments of resources used, contacts for support (eg Lifeline and Youthline), how to contact the researchers, and the online intervention.
The online intervention consists of 7 modules with one module being completed each day. Each module includes a section of psychoeducation around ACT and its core principles. This can either be read by the participant or there is the option of listening to an audio file of it. This information is then followed by a short (5-10min) video that practises some ACT aligned coping skills. The modules are completely self-directed with some follow along activities. The intervention has been created by a Masters in Health Psychology student and a team of health psychologists.
The modules are: Introduction to ACT and its application to chronic illness during a pandemic, defusion, being present and mindful, our observing mind, values, committed action, and acceptance.
The videos include relaxation (breathing, progressive muscle relaxation, and visualisation), a short meditation, self-compassion, goal setting, and gratitude.
Individual adherence to this intervention is monitored by a self-report question in the 4 week follow up questionnaire. Overall adherence to the intervention is measured by the feedback question which is completed after each module (i.e. if module 1 feedback was completed 30 times then adherence would be 30/46 participants adhered to module 1).

An additional focus group will be conducted to explore more in-depth feedback of this intervention. We will conduct two 1.5hr focus groups which will be facilitated by the student researcher and a PhD student who has experience in focus groups
Intervention code [1] 317669 0
Behaviour
Intervention code [2] 317670 0
Lifestyle
Comparator / control treatment
Wait-list control group will be offered the intervention after the intervention/treatment group have completed their 4-week follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 323917 0
Depression scores are assessed by the brief Depression, Anxiety, and Stress Scale (DASS; Lovibond & Lovibond, 1995).
Timepoint [1] 323917 0
Baseline and post-intervention (4 weeks after baseline)
Primary outcome [2] 323918 0
Anxiety scores are assessed by the brief Depression, Anxiety, and Stress Scale (DASS; Lovibond & Lovibond, 1995).
Timepoint [2] 323918 0
Baseline and post-intervention (4 weeks after baseline)
Primary outcome [3] 323919 0
Stress scores are assessed by the brief Depression, Anxiety, and Stress Scale (DASS; Lovibond & Lovibond, 1995).
Timepoint [3] 323919 0
Baseline and post-intervention (4 weeks after baseline)
Secondary outcome [1] 383324 0
Illness perceptions measured by the Brief Illness Perception Questionnaire (Brief-IPQ; Broadbent, Petrie, Main, & Weinman, 2006).
Timepoint [1] 383324 0
Baseline and post-intervention (4 weeks after baseline).
Secondary outcome [2] 383325 0
Mental wellbeing will be measured by the World Health Organisation Well-being Index (WHO-5; World Health Organization, 1998).
Timepoint [2] 383325 0
Baseline and post-intervention (4 weeks after baseline).
Secondary outcome [3] 383326 0
Psychological flexibility will be measured by the Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011).
Timepoint [3] 383326 0
Baseline and post-intervention (4 weeks after baseline).
Secondary outcome [4] 383327 0
Adherence will be measured via self-report by a question asking "How many modules did you complete?". Adherence will also be measured by the feedback questionnaire. This Feedback questionnaire is only available at the end of each module so the completion of this questionnaire will indicate adherence for that module.
Timepoint [4] 383327 0
Post-intervention (4 weeks after baseline)
Secondary outcome [5] 383328 0
Feedback will be collected from participants completing a short ‘Feedback’ questionnaire after using each module. This questionnaire will ask “How helpful did you find this module?” with the answer options being “I found this module very helpful”, “I found this module somewhat helpful”, “I found this module only a little bit helpful”, or “I found this module not helpful”. A second, optional, question will ask participants if they have any feedback on that module or the intervention so far. This question will be a qualitative written answer.
Timepoint [5] 383328 0
During the one week intervention (from baseline until 1 week)

Eligibility
Key inclusion criteria
1. Diagnosis of a chronic medical condition (e.g. cancer, asthma, autoimmune disorders, diabetes, or arthritis)
2. At least 18 years of age
3. Living in New Zealand
4. Ability to provide informed consent
5. Ability to understand, read and write English
6. Access to a computer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently hospitalised
2. Currently receiving treatment for a mental health condition
3. Currently doing regular mindfulness or meditation practice
4. Diagnosed with COVID-19

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to the intervention group or the wait-list control group. The wait-list group will start the intervention 4 weeks after the initial intervention group. Treatment allocations will be computer-generated using a computer-generated number sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated number sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A series of 2 (groups) x 2 (time) mixed-model ANOVAs and independent samples t-tests will assess differences across the two treatment arms (intervention versus waitlist) over time (baseline and four weeks after baseline). We will also conduct sub-group analyses, where we will examine between-group differences of participants allocated to the intervention group who had the highest depressive symptoms at baseline compared to the waitlist group at four weeks. If we have adequate power, we will also examine differences between ethnic groups.

Pearson’s correlations will explore the relationship between demographic characteristics, psychosocial factors, and depression, stress, and anxiety. Multiple linear regression will examine which measures are associated with depression, stress, or anxiety, as well as to explore possible moderators and mediators.

The qualitative data from the focus groups will be examined using Content Analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2020
Actual
23/06/2020
Date of last participant enrolment
Anticipated
Actual
2/07/2020
Date of last data collection
Anticipated
Actual
17/09/2020
Sample size
Target
46
Accrual to date
Final
46
Recruitment outside Australia
Country [1] 22574 0
New Zealand
State/province [1] 22574 0
Auckland

Funding & Sponsors
Funding source category [1] 305807 0
University
Name [1] 305807 0
University of Auckland
Country [1] 305807 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Department of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 306248 0
None
Name [1] 306248 0
Address [1] 306248 0
Country [1] 306248 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306078 0
The Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 306078 0
Ethics committee country [1] 306078 0
New Zealand
Date submitted for ethics approval [1] 306078 0
25/05/2020
Approval date [1] 306078 0
22/06/2020
Ethics approval number [1] 306078 0
AH1362

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102622 0
Dr Anna Serlachius
Address 102622 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 102622 0
New Zealand
Phone 102622 0
+64 9 923 3073
Fax 102622 0
Email 102622 0
a.serlachius@auckland.ac.nz
Contact person for public queries
Name 102623 0
Anna Serlachius
Address 102623 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 102623 0
New Zealand
Phone 102623 0
+64 9 923 3073
Fax 102623 0
Email 102623 0
a.serlachius@auckland.ac.nz
Contact person for scientific queries
Name 102624 0
Anna Serlachius
Address 102624 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 102624 0
New Zealand
Phone 102624 0
+64 9 923 3073
Fax 102624 0
Email 102624 0
a.serlachius@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants have not consented to sharing IPD


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
No additional documents have been identified.