ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001064897

Ethics application status

Approved

Date submitted

1/08/2021

Date registered

12/08/2021

Date last updated

19/10/2024

Date data sharing statement initially provided

12/08/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of a Brief Psychological Intervention on Anxiety and Depression During COVID-19

Scientific title

Randomised Controlled Trial of Brief Psychological Intervention versus Supportive Counseling on Anxiety and Depression in Indian Students 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

Infection

Other infectious diseases

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

There are two arms to this trial that were designed specifically for this trial. Arm 1: Psychological Intervention. Arm 2: Supportive Counselling. Therapy is administered once-weekly 60 minute sessions by peers with 3 or 4 years of undergraduate education over 6 weeks delivered via teleconferencing to groups of 4 people at a time. The intervention teaches participants the following stress coping strategies: anxiety reduction, problem solving, behavioral activation, and accessing social support. This will occur will via group discussions via teleconference. Treatment adherence will be assessed by checklist completed by facilitators. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 33 weeks.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

Supportive Counselling comprises once-weekly 60 minute sessions by peers with 3 or 4 years of undergraduate education over 6 weeks delivered via teleconferencing to groups of 4 people at a time. The Supportive Counselling comprises general group discussion and non-directive support related to coping with stress during COVID-19. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 33 weeks.

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 15; primary outcome timepoint), 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 15), and additional follow-up (week 33).

Secondary outcome [2]

Suicide as measured by the Suicide Ideation Attitudes Scale.

Timepoint [2]

Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), and additional follow-up (week 33).

Secondary outcome [3]

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

Timepoint [3]

Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), and additional follow-up (week 33).

Eligibility

Key inclusion criteria

Inclusion Criteria:
• Score of greater than or equal to 16 on the K10
• Aged at least 18 years
• University student
• 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
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 at least moderate anxiety or depression. 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

Completed

Date of first participant enrolment

Anticipated

1/12/2021

Actual

10/10/2021

Date of last participant enrolment

Anticipated

30/11/2022

Actual

5/12/2022

Date of last data collection

Anticipated

31/08/2023

Actual

3/07/2023

Sample size

Target

180

Accrual to date

Final

183

Recruitment outside Australia

Country [1]

India

State/province [1]

Bangalore

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]

Christ University Research Ethics Committee

Ethics committee address [1]

Christ University Research Ethics Committee
Hosur Rd, Bhavani Nagar, S.G. Palya, Bengaluru, Karnataka 560029, India

Ethics committee country [1]

India

Date submitted for ethics approval [1]

20/08/2021

Approval date [1]

04/10/2021

Ethics approval number [1]

CU:RECEC/64/10/21

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. One of the key groups of people who are highly distressed during the pandemic are university students because of the financial, academic, and social pressures on them. 

The UNSW team has developed suitable and evidence-based program that helps to cope with stress during the pandemic. 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 Coping with COVID to reduce distress in Indian university student 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. This brief program will be offered via teleconferencing to allow for social distancing on a group basis. We hypothesise that Coping with COVID will result in greater reductions in anxiety and depression  elative to supportive counselling.

Adults who screen positive for psychological distress will be randomized to Coping with COVID or supportive counseling via teleconferencing to groups of 4 people at a time. The control arm will provide 6 peer-led supportive counseling sessions delivering in groups of 4 people via video-conferencing.  All participants will be assessed at baseline, post-intervention, and 2 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 re-analyses of the data after approval from the Chief Investigator

Available for what types of analyses?

Meta-analyses or re-analyses 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

Source	Title	Year of Publication	DOI
Embase	Videoconferencing-delivered psychological intervention for the treatment of COVID-19 related psychological distress in University students: study protocol for a randomised controlled trial in India.	2022	https://dx.doi.org/10.1186/s12888-022-04471-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically