ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12620000468921

Ethics application status

Approved

Date submitted

30/03/2020

Date registered

14/04/2020

Date last updated

12/10/2021

Date data sharing statement initially provided

14/04/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of a Brief Problem Management Intervention on Covid 19-Related Anxiety and Depression

Scientific title

Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual 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

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

There are two arms to this trial. Arm 1: Problem Management Plus. Arm 2: Enhanced Treatment as Usual. 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. Problem Management Plus is a program developed by the World Health Organization. Across sessions the clinical psychologist will teach the following stress coping strategies: anxiety reduction, problem solving, behavioral activation, and accessing social support. This will occur will via educational sessions, group discussions via teleconference, and handouts.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

Enhanced Treatment as Usual comprises a link to a list of evidence-based strategy to manage stress in a self-guided manner. These strategies will be the same as provided in the Problem Management Plus condition but participants will be encouraged to practice the strategies for 6 weeks. These strategies will be emailed to participants. 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), 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]

Sleep difficulties as measured by the Sleep Impairment Index.

Timepoint [2]

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

Secondary outcome [3]

Positive affect as measured by the Pleasure Scale.

Timepoint [3]

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

Secondary outcome [4]

Affective state as measured by the Positive and Negative Affect Scale.

Timepoint [4]

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

Secondary outcome [5]

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

Timepoint [5]

Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), 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 2 months assessment.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

20/04/2020

Actual

20/05/2020

Date of last participant enrolment

Anticipated

13/07/2020

Actual

4/08/2020

Date of last data collection

Anticipated

12/05/2021

Actual

20/10/2020

Sample size

Target

240

Accrual to date

Final

240

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]

30/03/2020

Approval date [1]

03/05/2020

Ethics approval number [1]

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 Problem Management Plus (PM+), which was developed by the World Health Organization. As a low-intensity intervention for adults affected by adversity, this program teaches people well-documented strategies to manage stress.  This project aims to conduct a rapid trial of a brief psychological intervention, termed Problem Management Plus (PM+) 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. This brief program will be offered via teleconferencing to allow for social distancing on a group basis. We hypothesise that PM+ will result in greater reductions in distress and worry relative to provision of currently available online resources 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 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

+61 293853640

Fax

+61 293853641

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

+61 293853640

Fax

+61 293853641

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

+61 293853640

Fax

+61 293853641

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?

Metaanalyses 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

Source	Title	Year of Publication	DOI
Embase	Brief videoconferencing psychological intervention for reducing COVID-19 related distress: study protocol for a randomized controlled trial.	2021	https://dx.doi.org/10.1186/s12889-021-10529-x

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically