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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
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Scientific title
Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual on Anxiety and Depression in People Distressed by Covid 19
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Secondary ID [1]
300852
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anxiety
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Depression
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COVID-19
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Condition category
Condition code
Mental Health
314990
314990
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0
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Anxiety
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Mental Health
314991
314991
0
0
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Depression
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Infection
315094
315094
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
317179
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Behaviour
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Intervention code [2]
317180
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Anxiety and depression represent a composite primary outcome, as measured by the Hospital Anxiety and Depression scale.
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Assessment method [1]
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Timepoint [1]
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Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 15), additional follow-up (week 33).
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Secondary outcome [1]
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Worry as measured by the Generalized Anxiety DIsorder 7.
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Assessment method [1]
381569
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Timepoint [1]
381569
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Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), and additional follow-up (week 33).
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Secondary outcome [2]
381570
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Sleep difficulties as measured by the Sleep Impairment Index.
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Assessment method [2]
381570
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Timepoint [2]
381570
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Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), additional follow-up (week 33).
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Secondary outcome [3]
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Positive affect as measured by the Pleasure Scale.
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Assessment method [3]
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Timepoint [3]
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Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), additional follow-up (week 33)
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Secondary outcome [4]
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Affective state as measured by the Positive and Negative Affect Scale.
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Assessment method [4]
391485
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Timepoint [4]
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Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), additional follow-up (week 33)
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Secondary outcome [5]
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Worries about COVID-19 as measured by the COVID-19 Stress Scale.
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Assessment method [5]
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Timepoint [5]
391486
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Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), additional follow-up (week 33)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
20/04/2020
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Actual
20/05/2020
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Date of last participant enrolment
Anticipated
13/07/2020
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Actual
4/08/2020
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Date of last data collection
Anticipated
12/05/2021
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Actual
20/10/2020
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Sample size
Target
240
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Accrual to date
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Final
240
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NHMRC
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Address [1]
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16 Marcus Clarke St,
Canberra ACT 2601
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Country [1]
305305
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Australia
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Primary sponsor type
University
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Name
UNSW Sydney
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Address
Anzac Pde, Kensington, NSW, 2052
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Country
Australia
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Secondary sponsor category [1]
305702
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None
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Name [1]
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NA
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Address [1]
305702
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NA
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Country [1]
305702
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305644
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UNSW Human Research Ethics Committee
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Ethics committee address [1]
305644
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UNSW HREC UNSW Sydney Sydney NSW 2052
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Ethics committee country [1]
305644
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Australia
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Date submitted for ethics approval [1]
305644
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30/03/2020
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Approval date [1]
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03/05/2020
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Ethics approval number [1]
305644
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Richard Bryant
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Address
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School of Psychology
University of New South Wales
Sydney NSW 2052
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Country
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Australia
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Phone
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+61 293853640
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Fax
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+61 293853641
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Email
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[email protected]
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Contact person for public queries
Name
101067
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Richard Bryant
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Address
101067
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School of Psychology
University of New South Wales
Sydney NSW 2052
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Country
101067
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Australia
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Phone
101067
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+61 293853640
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Fax
101067
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+61 293853641
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Email
101067
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[email protected]
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Contact person for scientific queries
Name
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Richard Bryant
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Address
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School of Psychology
University of New South Wales
Sydney NSW 2052
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Country
101068
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Australia
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Phone
101068
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+61 293853640
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Fax
101068
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+61 293853641
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Email
101068
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD and related data dictionaries are available
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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.
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Available to whom?
Researchers wishing to conduct reanalyses of the data.
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Available for what types of analyses?
Metaanalyses or reanalyses of subgroups
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How or where can data be obtained?
By emailing the Principal Investigator (email:
[email protected]
).
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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.
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