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Trial registered on ANZCTR


Registration number
ACTRN12620000468921p
Ethics application status
Submitted, not yet approved
Date submitted
30/03/2020
Date registered
14/04/2020
Date last updated
14/04/2020
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] 300852 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 316760 0
Depression 316761 0
COVID-19 316919 0
Condition category
Condition code
Mental Health 314990 314990 0 0
Anxiety
Mental Health 314991 314991 0 0
Depression
Infection 315094 315094 0 0
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 2-month follow-up assessment, resulting in participation duration of 15 weeks.
Intervention code [1] 317179 0
Behaviour
Intervention code [2] 317180 0
Treatment: Other
Comparator / control treatment
Enhanced Treatment as Usual comprises a link to a website outlining an evidence-based mindfulness strategy to manage stress. Participants will be encouraged to practice strategy on at least a once-weekly basis for 6 weeks. This strategy involves a guided mindfulness exercise that will lead the participant in a 9-minute exercise that employs meditation-related strategies. The link can be found at: https://www.youtube.com/watch?list=PLgE_M4qIgO35x0oJY6swqZ0Qu322-PNLH&v=RUXyXnIOxtg&feature=emb_title. The duration of the study for any participant will conclude after a 2-month follow-up assessment, resulting in participation duration of 15 weeks.
Control group
Active

Outcomes
Primary outcome [1] 323325 0
Anxiety and depression represent a composite primary outcome, as measured by the Hospital Anxiety and Depression scale.
Timepoint [1] 323325 0
Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 15).
Secondary outcome [1] 381569 0
Worry as measured by the Generalized Anxiety DIsorder 7.
Timepoint [1] 381569 0
Pretreatment (week 1), posttreatment (week 7), and follow-up (week 15).
Secondary outcome [2] 381570 0
Sleep difficulties as measured by the Sleep Impairment Index.
Timepoint [2] 381570 0
Pretreatment (week 1), posttreatment (week 7), and follow-up (week 15).
Secondary outcome [3] 381571 0
Social support as measured by the Social Support Scale.
Timepoint [3] 381571 0
Pretreatment (week 1), posttreatment (week 7), and follow-up (week 15).
Secondary outcome [4] 381753 0
Quality of Life as measured by the WHO-5.
Timepoint [4] 381753 0
Pretreatment (week 1), posttreatment (week 7), and follow-up (week 15).

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 2 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)
NSW

Funding & Sponsors
Funding source category [1] 305305 0
Government body
Name [1] 305305 0
NHMRC
Address [1] 305305 0
16 Marcus Clarke St,
Canberra ACT 2601
Country [1] 305305 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Anzac Pde, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 305702 0
None
Name [1] 305702 0
NA
Address [1] 305702 0
NA
Country [1] 305702 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305644 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 305644 0
UNSW HREC
UNSW Sydney
Sydney NSW 2052
Ethics committee country [1] 305644 0
Australia
Date submitted for ethics approval [1] 305644 0
30/03/2020
Approval date [1] 305644 0
Ethics approval number [1] 305644 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 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 101066 0
Prof Richard Bryant
Address 101066 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 101066 0
Australia
Phone 101066 0
+61 293853640
Fax 101066 0
+61 293853641
Email 101066 0
r.bryant@unsw.edu.au
Contact person for public queries
Name 101067 0
Prof Richard Bryant
Address 101067 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 101067 0
Australia
Phone 101067 0
+61 293853640
Fax 101067 0
+61 293853641
Email 101067 0
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 101068 0
Prof Richard Bryant
Address 101068 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 101068 0
Australia
Phone 101068 0
+61 293853640
Fax 101068 0
+61 293853641
Email 101068 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?
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 other documents available
Summary results
No Results