ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001245886

Ethics application status

Approved

Date submitted

29/08/2021

Date registered

15/09/2021

Date last updated

19/04/2023

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Depression

COVID-19

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Respiratory

Other respiratory disorders / diseases

Infection

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]

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]

Anxiety and depression represent a composite primary outcome, as measured by the Hospital Anxiety and Depression scale.

Timepoint [1]

Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 19), additional follow-up (week 33).

Secondary outcome [1]

Worry as measured by the Generalized Anxiety DIsorder 7.

Timepoint [1]

Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 33).

Secondary outcome [2]

Worries about COVID-19 as measured by the COVID-19 Stress Scale.

Timepoint [2]

Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 33).

Secondary outcome [3]

Suicidal ideations as measured by the Suicidal Ideation Attributes Scale.

Timepoint [3]

Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 33).

Secondary outcome [4]

Quality of Life as measured by the Australian Quality of Life

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Recruiting

Date of first participant enrolment

Anticipated

29/09/2021

Actual

10/01/2022

Date of last participant enrolment

Anticipated

1/05/2023

Actual

Date of last data collection

Anticipated

5/02/2024

Actual

Sample size

Target

204

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

16 Marcus Clarke St,
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

UNSW Sydney

Address

Anzac Pde, Kensington, NSW, 2052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNSW Human Research Ethics Committee

Ethics committee address [1]

UNSW HREC
UNSW Sydney
Sydney NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/08/2021

Approval date [1]

23/09/2021

Ethics approval number [1]

HC210701

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

Prof Richard Bryant

Address

School of Psychology
University of New South Wales
Sydney NSW 2052

Country

Australia

Phone

+61405375874

Fax

r.bryant@unsw.edu.au

Contact person for public queries

Name

Richard Bryant

Address

School of Psychology
University of New South Wales
Sydney NSW 2052

Country

Australia

Phone

+61405375874

Fax

r.bryant@unsw.edu.au

Contact person for scientific queries

Name

Richard Bryant

Address

School of Psychology
University of New South Wales
Sydney NSW 2052

Country

Australia

Phone

+61405375874

Fax

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 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.

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