Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001064897
Ethics application status
Approved
Date submitted
1/08/2021
Date registered
12/08/2021
Date last updated
14/11/2022
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] 304924 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 323069 0
Depression 323070 0
COVID-19 323071 0
Condition category
Condition code
Mental Health 320647 320647 0 0
Anxiety
Mental Health 320648 320648 0 0
Depression
Infection 320649 320649 0 0
Other infectious diseases
Respiratory 320701 320701 0 0
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] 321320 0
Behaviour
Intervention code [2] 321321 0
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] 328462 0
Anxiety and depression represent a composite primary outcome, as measured by the Hospital Anxiety and Depression scale.
Timepoint [1] 328462 0
Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 15; primary outcome timepoint), additional follow-up (week 33).
Secondary outcome [1] 399087 0
Worry as measured by the Generalized Anxiety DIsorder 7.
Timepoint [1] 399087 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), and additional follow-up (week 33).
Secondary outcome [2] 399088 0
Suicide as measured by the Suicide Ideation Attitudes Scale.
Timepoint [2] 399088 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), and additional follow-up (week 33).
Secondary outcome [3] 399089 0
Worries about COVID-19 as measured by the COVID-19 Stress Scale.
Timepoint [3] 399089 0
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?
No
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
Recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
4/03/2022
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
180
Accrual to date
152
Final
Recruitment outside Australia
Country [1] 24019 0
India
State/province [1] 24019 0
Bangalore

Funding & Sponsors
Funding source category [1] 309304 0
Government body
Name [1] 309304 0
NHMRC
Country [1] 309304 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Anzac Pde, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 310277 0
None
Name [1] 310277 0
NA
Address [1] 310277 0
NA
Country [1] 310277 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309134 0
Christ University Research Ethics Committee
Ethics committee address [1] 309134 0
Christ University Research Ethics Committee
Hosur Rd, Bhavani Nagar, S.G. Palya, Bengaluru, Karnataka 560029, India
Ethics committee country [1] 309134 0
India
Date submitted for ethics approval [1] 309134 0
20/08/2021
Approval date [1] 309134 0
04/10/2021
Ethics approval number [1] 309134 0
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 113102 0
Prof Richard Bryant
Address 113102 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 113102 0
Australia
Phone 113102 0
+61405375874
Fax 113102 0
Email 113102 0
[email protected]
Contact person for public queries
Name 113103 0
Prof Richard Bryant
Address 113103 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 113103 0
Australia
Phone 113103 0
+61405375874
Fax 113103 0
Email 113103 0
[email protected]
Contact person for scientific queries
Name 113104 0
Prof Richard Bryant
Address 113104 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 113104 0
Australia
Phone 113104 0
+61405375874
Fax 113104 0
Email 113104 0
[email protected]

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: [email protected]).


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
SourceTitleYear of PublicationDOI
EmbaseVideoconferencing-delivered psychological intervention for the treatment of COVID-19 related psychological distress in University students: study protocol for a randomised controlled trial in India.2022https://dx.doi.org/10.1186/s12888-022-04471-4
N.B. These documents automatically identified may not have been verified by the study sponsor.