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Trial registered on ANZCTR


Registration number
ACTRN12620000779976
Ethics application status
Approved
Date submitted
9/07/2020
Date registered
30/07/2020
Date last updated
17/12/2020
Date data sharing statement initially provided
30/07/2020
Date results information initially provided
17/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Cognitive behaviour therapy on adult mental health during the COVID-19 pandemic.
Scientific title
A pragmatic study to disseminate low intensity, evidence supported Cognitive behaviour therapy and the effect on anxiety and depression in adults during the COVID-19 pandemic
Secondary ID [1] 301729 0
Script ID through Curtin University: RES-62642
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 318185 0
Depression 318186 0
Condition category
Condition code
Mental Health 316198 316198 0 0
Anxiety
Mental Health 316199 316199 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group names: Immediate and Waitlist

The study will involve providing participants with a low-intensity, self-help CBT guide to coping with anxiety and depression during the COVID-19 pandemic, developed specifically for the current study. This will include information for children (use of parts relating to children will be facilitated by adult participants only), adolescents (use of parts relating to adolescents will be facilitated by adult participants only), and adults (including older adults), and include simplified CBT coping strategies as well as a comprehensive resource list of the many internet-based CBT programs, websites, and self-help books available as e-books to help people recognize and address different types of unhelpful thought patterns and behaviours which may contribute to heightened anxiety and depression during the pandemic. Coping strategies included in the guide include:
- Taking action to protect yourself against COVID-19 by following expert guidelines (COVID-19 specific)
- Engage in general self-care (non-COVD-19 specific)
- Engage in pleasant events (non-COVD-19 specific)
- Ways to deal with worry and rumination (non-COVD-19 specific)
- Ways to deal with anxiety over your health (non-COVD-19 specific)
- Ways to deal with anxiety over your finances (non-COVD-19 specific)
- Engage in problem solving (non-COVD-19 specific)
- Relaxation Exercises (non-COVD-19 specific)
- Mindfulness (non-COVD-19 specific)
- Exercise (non-COVD-19 specific)
- Challenge unhelpful thoughts with thought records (non-COVD-19 specific)
- Challenging unhelpful thoughts with behavioural experiments (non-COVD-19 specific)

All participants will be provided with an online information and consent form outlining what will be involved in the trial. Once they have provided consent (by completing the form online), they will complete a form with a set of screening questions to assess their potential suicidality risk. Those who are high-risk will be directed to alternative mental health services (via email) and will be exited from the trial. Those who are low-risk will then go on to complete the pre-intervention questionnaire (online survey), which will include demographics questions, a measure of anxiety (GADS-7) and a measure of depression (PHQ-9).

Participants will then be randomised (automatically through the survey software) to one of the two groups.

Immediate intervention group:
Participants in the Immediate Group will be emailed the CBT self-help guide immediately, and will be directed to spend the next week reading over the information. At the end of one week accessing the guide, they will be emailed an online link to the post-intervention questionnaire. This questionnaire will once again include the GAD-7 and PHQ-9, as well as questions relating to participant's use of and adherence to the strategies presented within the guide (e.g., how many hours spent reading the guide, what percentage of the guide was read, which of the strategies or external resources were used).

Waitlist intervention group:
Participants in the Waitlist Group will be informed via email that they will be emailed the CBT self-help guide in one week's time. One week after completing the pre-intervention questionnaire, they will be emailed an online link to the post-intervention questionnaire. After completing the post-intervention questionnaire, they will be emailed the CBT self-help guide.

All participants who complete the post-intervention questionnaire will be emailed a $20 Amazon voucher. The survey will also include a final question asking if they would like to participate in a feedback interview via phone or internet with one of the research assistants. If they agree to participate in the interview, they will be emailed a link to a second information and consent form explaining what the interview will involve. Once they provide consent, they will then be emailed a link to a bookings website where they will be able to select a time and date for the interview. Once a time is scheduled, one of the research assistants will contact the participant in order to arrange either a phone call or a call over the internet.

The research assistants, who are provisionally and generally registered psychologists with experience conducting feedback interviews for research, will conduct the remote interviews from a secure and confidential location.

Participants who complete the feedback interviews will be emailed an additional $20 Amazon voucher.

Fidelity will be checked using a random selection of the interviews, which will be transcribed, by cross-checking the transcriptions against the list of feedback questions to be covered in the interviews.
Intervention code [1] 318030 0
Behaviour
Comparator / control treatment
Waitlist control group - half of the participants will be asked to wait one week before receiving the guide (see above description of interventions/exposure)
Control group
Active

Outcomes
Primary outcome [1] 324381 0
Anxiety, as measured by mean scores on the Generalized Anxiety Disorder 7 (GAD-7).

Timepoint [1] 324381 0
Baseline, and one week after intervention commencement.
Primary outcome [2] 324382 0
Depression, as measured by mean scores on the Patient Health Questionnaire (PHQ-9).
Timepoint [2] 324382 0
Baseline, and one week after intervention commencement.
Secondary outcome [1] 384502 0
Extent to which the guide was used (e.g., how much of the guide was read, time spent using the guide, usefulness of the guide, and how easy the guide was to read), as measured by four items sourced from:
Thiels, C., Schmidt, U., Treasure, J., Garthe, R., & Troop, N. (1998). Guided self- change for bulimia nervosa incorporating use of a self-care manual.
American Journal of Psychiatry, 155, 947-953. doi:10.1176/ajp.155.7.947

(composite secondary outcome)
Timepoint [1] 384502 0
One week after intervention commencement.
Secondary outcome [2] 384514 0
Ease of use for various components of the guide (e.g., information read, strategies provided, additional resources suggested) as measured by three items sourced from:
Rozental, A., Kothari, R., Wade, T., Egan, S.J., Andersson, G., Carlbring, P., & Shafran, R. (2020). Reconsidering perfect: A qualitative study of the experiences of Internet-based cognitive behaviour therapy for perfectionism. Behavioural and Cognitive Psychotherapy.
Timepoint [2] 384514 0
One week after intervention commencement.
Secondary outcome [3] 384518 0
Use of specific strategies and resources, as measured by two questions listing all of the strategies and resources included in the guide (questions designed specifically for this study).
Timepoint [3] 384518 0
One week after intervention commencement.
Secondary outcome [4] 384524 0
Feedback preferences for the guide (e.g., format of guide, additional in-person guidance, any gaps in the resources, and additional comments) as measured by 6 questions (questions designed specifically for this study).
Timepoint [4] 384524 0
One week after intervention commencement.
Secondary outcome [5] 384525 0
General feedback about the usefulness and relevance of the guide, as measured by a feedback interview that will be transcribed and analysed using thematic analysis.
Timepoint [5] 384525 0
After the completion of the post-intervention questionnaire, at varying time points based on participant's schedule.

Eligibility
Key inclusion criteria
Participants who are 18 years of age or over, low risk in terms of their suicidality (i.e., those who score below 6 on a set of screening questions to assess risk of suicidality sourced from the MINI-5.0), and have access to a computer or smart phone will be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who participate will complete a set of screening questions to assess risk of suicidality (sourced from the MINI-5.0), and only low-risk participants (those who score below 6) will be included in the trial. Those who score as moderate-high-risk (6 or more) will not be eligible, however they will be directed to alternative sources of support and will still be provided with the guide.

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)
Yes, allocated by survey software (Qualtrics).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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
Analysis of the pre- post-intervention data will consist of Generalised Linear Mixed Modelling through SPSS to detect effects of the intervention versus the waitlist control group.

The transcripts from the advisory group will be analysed using thematic analysis to gain an understanding of themes in participant’s views, using grounded theory. The interview content will be used to help inform the overall synthesis and content of the review.

Recruitment
Recruitment status
Completed
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
Recruitment outside Australia
Country [1] 22974 0
United Kingdom
State/province [1] 22974 0
All

Funding & Sponsors
Funding source category [1] 306167 0
Government body
Name [1] 306167 0
Government of Western Australia's Research Development Unit - COVID-19 Research Grants Program
Address [1] 306167 0
WA Department of Health
189 Royal St
East Perth WA 6004
Country [1] 306167 0
Australia
Funding source category [2] 306170 0
University
Name [2] 306170 0
Curtin University
Address [2] 306170 0
Curtin University
Kent St
Bentley WA 6102
Country [2] 306170 0
Australia
Primary sponsor type
Individual
Name
Dr Sarah Egan
Address
Curtin University
Kent St
Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 306637 0
Individual
Name [1] 306637 0
Professor Tracey Wade
Address [1] 306637 0
Flinders University
Sturt Rd
Bedford Park SA 5042
Country [1] 306637 0
Australia
Other collaborator category [1] 281382 0
Individual
Name [1] 281382 0
Professor Peter McEvoy
Address [1] 281382 0
Curtin University
Kent St
Bentley WA 6102
Country [1] 281382 0
Australia
Other collaborator category [2] 281383 0
Individual
Name [2] 281383 0
Professor Roz SHAFRAN
Address [2] 281383 0
University College London
Gower St
Bloomsbury, London WC1E 6BT
Country [2] 281383 0
United Kingdom
Other collaborator category [3] 281384 0
Individual
Name [3] 281384 0
Dr Rebecca ANDERSON
Address [3] 281384 0
Curtin University
Kent St
Bentley WA 6102
Country [3] 281384 0
Australia
Other collaborator category [4] 281385 0
Individual
Name [4] 281385 0
Dr Trevor Mazzucchelli
Address [4] 281385 0
Curtin University
Kent St
Bentley WA 6102
Country [4] 281385 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306380 0
Curtin University Human Research Ethics Committee (HREC)
Ethics committee address [1] 306380 0
Kent St
Bentley WA 6102
Ethics committee country [1] 306380 0
Australia
Date submitted for ethics approval [1] 306380 0
30/06/2020
Approval date [1] 306380 0
31/07/2020
Ethics approval number [1] 306380 0
HRE2020-0424

Summary
Brief summary
In these unprecedented times of global concern associated with the effects of COVID-19, the aim of the study is to produce and disseminate a low-intensity, self-help CBT guide to coping with anxiety and depression during the COVID-19 pandemic. This will include information for use with regards to children (use of parts relating to children will be facilitated by adult participants only), adolescents (use of parts relating to adolescents will be facilitated by adult participants only), and adults (including older adults) and include simplified CBT coping strategies as well as a comprehensive resource list of the many internet-based CBT programs, websites, and self-help books available as e-books to help people recognize and address different types of unhelpful thought patterns and behaviours which may contribute to heightened anxiety and depression during the pandemic. The recommendations for coping strategies and resources will be compiled by an international panel of experts in CBT.

The guide will be disseminated through GP practices, WA hospitals, public mental health services, private mental health services and WA government websites, and the research will involve feedback from consumers on the relevance and usefulness of the information in relation to their stress, worry and low mood related to the pandemic. The information will be evaluated for the effectiveness of the treatment on symptoms of anxiety and depression.

Research Questions and Hypotheses:
1. Do adult consumers find the CBT strategies to improving mental health guide for COVID-19 useful as indicated by their qualitative feedback in interviews? Due to the exploratory nature of this question no specific hypotheses are outlined.

2. Is there evidence through a pilot investigation of the efficacy of the guide in decreasing anxiety and depression in adults?
It is hypothesised that participants randomised to the intervention will show significantly lower symptoms of anxiety on the GAD-7 and depression on the PHQ-9 after 1 week compared to control participants.

3. Can a CBT guide to improving mental health during COVID-19 be produced which covers strategies for both and adults and children (including those with specific needs, for example children with special needs such as Autism; use of parts relating to children will be facilitated by adult participants only)?
Trial website
https://covidcbt.org/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103682 0
Dr Sarah Egan
Address 103682 0
Curtin University
Kent St
Bentley WA 6102
Country 103682 0
Australia
Phone 103682 0
+61892669266
Fax 103682 0
Email 103682 0
s.egan@curtin.edu.au
Contact person for public queries
Name 103683 0
Dr Sarah Egan
Address 103683 0
Curtin University
Kent St
Bentley WA 6102
Country 103683 0
Australia
Phone 103683 0
+61892669266
Fax 103683 0
Email 103683 0
s.egan@curtin.edu.au
Contact person for scientific queries
Name 103684 0
Dr Sarah Egan
Address 103684 0
Curtin University
Kent St
Bentley WA 6102
Country 103684 0
Australia
Phone 103684 0
+61892669266
Fax 103684 0
Email 103684 0
s.egan@curtin.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?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Available following publication of the trial results.
No end date determined
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal determined on a case-by-case basis at the discretion of Primary Sponsor.
How or where can data be obtained?
Individuals may request data from the primary investigator, Sarah Egan, by emailing S.Egan@exchange.curtin.edu.au.
What supporting documents are/will be available?
Informed consent form
Ethical approval
Other
'Other' documents specified
CBT self-help guide
How or where can supporting documents be obtained?
Type [1] 8446 0
Informed consent form
Citation [1] 8446 0
Link [1] 8446 0
Email [1] 8446 0
MentalHealthCovid@curtin.edu.au
Other [1] 8446 0
Type [2] 8447 0
Other
Citation [2] 8447 0
Link [2] 8447 0
Email [2] 8447 0
MentalHealthCovid@curtin.edu.au
Other [2] 8447 0
Type [3] 8448 0
Ethical approval
Citation [3] 8448 0
Link [3] 8448 0
Email [3] 8448 0
Other [3] 8448 0
Once approved, ethical approval details will be included on the information and consent form.
Attachment [3] 8448 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary