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Trial registered on ANZCTR


Registration number
ACTRN12621001245886p
Ethics application status
Submitted, not yet approved
Date submitted
29/08/2021
Date registered
15/09/2021
Date last updated
15/09/2021
Date data sharing statement initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a Videoconferencing-Based Program on Covid 19-Related Anxiety and Depression
Scientific title
Randomised Controlled Trial of a Videoconferencing-Based Program versus a Smartphone App Program on Anxiety and Depression in People Distressed by Covid 19
Secondary ID [1] 305162 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 323431 0
Depression 323432 0
COVID-19 323433 0
Condition category
Condition code
Mental Health 320984 320984 0 0
Anxiety
Mental Health 320985 320985 0 0
Depression
Respiratory 320986 320986 0 0
Other respiratory disorders / diseases
Infection 321165 321165 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1: Coping with COVID. Arm 2: App program. The Coping with COVID program is an evidence-based psychological intervention that is available from www.traumaticstressclinic.com. Therapy is administered once-weekly 60 minute sessions by clinical psychologists over 6 weeks delivered via teleconferencing to groups of 4 people at a time. In Coping with COVID a clinical psychologist will teach the following stress coping strategies: anxiety reduction, problem solving, behavioral activation, worry management, and accessing social support. This will occur will via educational sessions, group discussions via teleconference, and handouts to be completed between sessions; handouts will require approximately 30 minutes per week. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 33 weeks. Adherence will be assessed by monitoring participants' attendance at videoconferencing sessions via a checklist maintained by the clinical psychologist.
Intervention code [1] 321567 0
Behaviour
Comparator / control treatment
The Headgear is an evidence-based app that is available on the App Store. The app comprises a link to a program that guides the person through evidence-based strategies to manage stress. These strategies will be conducted in daily exercises over a 30-day period, with each day requiring approximately 5 minutes. These strategies will comprise mood monitoring, behavioural activation, social support skills, and stress coping. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 33 weeks. Treatment adherence will be monitored by the Headgear app monitoring the number of days people log in to the program.
Control group
Active

Outcomes
Primary outcome [1] 328764 0
Anxiety and depression represent a composite primary outcome, as measured by the Hospital Anxiety and Depression scale.
Timepoint [1] 328764 0
Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 19), additional follow-up (week 33).
Secondary outcome [1] 400253 0
Worry as measured by the Generalized Anxiety DIsorder 7.
Timepoint [1] 400253 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 33).
Secondary outcome [2] 400254 0
Worries about COVID-19 as measured by the COVID-19 Stress Scale.
Timepoint [2] 400254 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 33).
Secondary outcome [3] 400255 0
Suicidal ideations as measured by the Suicidal Ideation Attributes Scale.
Timepoint [3] 400255 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 33).
Secondary outcome [4] 400256 0
Quality of Life as measured by the Australian Quality of Life
Timepoint [4] 400256 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 33).

Eligibility
Key inclusion criteria
Inclusion Criteria:
• Score of greater than or equal to 3 on the General Health Questionnaire
• Aged at least 18 years
• Sufficient English language comprehension
• Access to teleconferencing platform
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
• Current psychosis
• Imminent suicidal risk
• Current substance dependence (but not abuse)
No access to internet-based access to teleconferencing facility

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 will be adults indicating moderate distress. Participants wishing to
participate will be randomly allocated according to a random numbers system administered by an individual who independent of the study and who works at a site that is independent from the trial centre.
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses will focus primarily on intent-to-treat analysis. Using SPSS version 24, hierarchical linear mixed models (HLM) will be used to study differential effects of each treatment condition because this method effectively handles missing data by calculating estimates of trajectories. For the folow-up analyses between the two conditions, analyses will focus on linear time effects, treatment conditions, and interactions. Fixed effects parameters were tested with the Wald test (t-test, p <.05, two-sided) and 95% confidence intervals. Cohen’s (d) effect size was calculated for all analyses. The primary outcome measure will be the HADS. The primary outcome timepoint will be the 3 months assessment.

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] 309551 0
Government body
Name [1] 309551 0
NHMRC
Address [1] 309551 0
16 Marcus Clarke St,
Canberra ACT 2601
Country [1] 309551 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Anzac Pde, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 310550 0
None
Name [1] 310550 0
NA
Address [1] 310550 0
NA
Country [1] 310550 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309331 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 309331 0
UNSW HREC
UNSW Sydney
Sydney NSW 2052
Ethics committee country [1] 309331 0
Australia
Date submitted for ethics approval [1] 309331 0
30/08/2021
Approval date [1] 309331 0
Ethics approval number [1] 309331 0

Summary
Brief summary
The global impact of COVID-19 has been profound, and the public health threat it represents is the most serious seen in recent pandemic history. Thus, concerns about COVID-19 are pervasive and have several serious adverse impacts on the mental health of health workers and the general community. There is an urgent demand for programs that can address the stress experienced by people during the COVID-19 pandemic. This situation does not require therapy because these personnel do not necessarily suffer from a mental disorder. Instead, there are huge numbers of people who are facing unprecedented levels of stress and require strategies to manage this stress.

A suitable and evidence-based program that helps to cope with stress in times of crisis is the Coping with COVID (CWC). As a low-intensity intervention for adults affected by the pandemic, this program teaches people well-documented strategies to manage stress. This project aims to conduct a rapid trial of a brief psychological intervention, termed CWC to reduce distress associated with concerns about COVID-19. There is an urgent need for publicly available strategies to reduce COVID-19 related distress. This project does not aim to treat a mental disorder but rather alleviate distress and improve coping in people with distress about COVID-19. The most common mental health programs implemented in the pandemic are videoconferencing-delivered programs and app programs. This trial compares the efficacy of these two types of programs by comparing CWC and a proven mental health app program. We hypothesise that CWC will result in greater reductions in anxiety, depression, and worry relative to the app to manage distress.

Adults who screen positive for psychological distress will be randomized to PM+ or a control condition. PM+ will comprise 6 x 60-minute sessions delivered by a clinical psychologist via teleconferencing to groups of 4 people at a time. The control arm will direct people to a portal with stress coping strategies. All participants will be assessed at baseline, post-intervention, and 3 and 6 months follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113790 0
Prof Richard Bryant
Address 113790 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 113790 0
Australia
Phone 113790 0
+61405375874
Fax 113790 0
Email 113790 0
r.bryant@unsw.edu.au
Contact person for public queries
Name 113791 0
Prof Richard Bryant
Address 113791 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 113791 0
Australia
Phone 113791 0
+61405375874
Fax 113791 0
Email 113791 0
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 113792 0
Prof Richard Bryant
Address 113792 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 113792 0
Australia
Phone 113792 0
+61405375874
Fax 113792 0
Email 113792 0
r.bryant@unsw.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?
IPD and related data dictionaries are available
When will data be available (start and end dates)?
Data will be available following publication of the study outcomes. There is no end date for when this data will be available.
Available to whom?
Researchers wishing to conduct reanalyses of the data.
Available for what types of analyses?
Meta-analyses or reanalyses of subgroups
How or where can data be obtained?
By emailing the Principal Investigator (email: r.bryant@unsw.edu.au).
What supporting documents are/will be available?
No other documents available
Summary results
No Results