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Trial registered on ANZCTR


Registration number
ACTRN12620000787987p
Ethics application status
Submitted, not yet approved
Date submitted
24/07/2020
Date registered
4/08/2020
Date last updated
4/08/2020
Date data sharing statement initially provided
4/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a Brief Problem Management Intervention on Anxiety and Depression Arising from COVID-19-Related Financial Stress
Scientific title
Randomised Controlled Trial of Problem Management Plus versus Enhanced Treatment as Usual on Anxiety and Depression in People Distressed by Financial Problems Due to COVID-19
Secondary ID [1] 301879 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Anxiety 318376 0
Depression 318377 0
COVID-19 318378 0
Condition category
Condition code
Mental Health 316394 316394 0 0
Anxiety
Mental Health 316395 316395 0 0
Depression
Infection 316396 316396 0 0
Other infectious diseases
Respiratory 316474 316474 0 0
Other respiratory disorders / 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 7 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, mood improvement strategies, worry management, and accessing social support. This will occur will via educational sessions, group discussions via teleconference, and app-based homework assignments. Homework will include mood monitoring, prompts to engage in positive activities, prompts to engage in social interaction, and prompts to limit worry time. App analytic data will measure adherence to homework tasks. Clinical psychologists will be trained by the WHO author of PM+, and will be supplemented by completion of conducting practice groups under supervision. 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] 318168 0
Behaviour
Intervention code [2] 318169 0
Treatment: Other
Comparator / control treatment
Enhanced Treatment as Usual comprises being provided a self-guided manual of the strategies taught in PM+ to manage financial stress in a self-paced 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, and will comprise instructions in anxiety reduction, problem solving, mood improvement strategies, worry management, and accessing social support. 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] 324549 0
Anxiety and depression represent a composite primary outcome, as measured by the Hospital Anxiety and Depression scale.
Timepoint [1] 324549 0
Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 19), additional follow-up (week 59).
Secondary outcome [1] 384956 0
Worry as measured by the Generalized Anxiety DIsorder 7.
Timepoint [1] 384956 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 59).
Secondary outcome [2] 384957 0
Health related quality of life will be measured using Australian Quality of Life
Timepoint [2] 384957 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 59).
Secondary outcome [3] 384958 0
Suicidal ideation as measured by the Scale for Suicidal Ideation.
Timepoint [3] 384958 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 59).
Secondary outcome [4] 384959 0
Positive affect as measured by the Pleasure Scale.
Timepoint [4] 384959 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 59).
Secondary outcome [5] 385243 0
Labour productivity will be assessed using the iMTA Productivity Cost Questionnaire
Timepoint [5] 385243 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 19), additional follow-up (week 59).

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
NA
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306299 0
Government body
Name [1] 306299 0
NHMRC
Address [1] 306299 0
16 Marcus Clarke St,
Canberra ACT 2601
Country [1] 306299 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Anzac Pde, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 306792 0
None
Name [1] 306792 0
NA
Address [1] 306792 0
NA
Country [1] 306792 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306514 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 306514 0
UNSW HREC
UNSW Sydney
Sydney NSW 2052
Ethics committee country [1] 306514 0
Australia
Date submitted for ethics approval [1] 306514 0
22/07/2020
Approval date [1] 306514 0
Ethics approval number [1] 306514 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. One of the major impacts of COVID-19 is the long-standing financial stress that it is imposing on millions of people worldwide. Unemployment, under-employment, and other forms of financial stress are causing marked increases in depression, anxiety, and suicide risk. There is an urgent demand for programs that can address the effects of financial stress experienced by people during the COVID-19 pandemic. There are major challenges in dealing with this issue because this mental health problem is affecting unprecedented numbers of people, it is affecting people all across Australia and beyond regions traditionally serviced by mental health services, and people are limited in accessing health services in the context of social distancing.

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 7 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 3 and 24 months follow-up.
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 104122 0
Prof Richard Bryant
Address 104122 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 104122 0
Australia
Phone 104122 0
+61293853640
Fax 104122 0
+61293853641
Email 104122 0
r.bryant@unsw.edu.au
Contact person for public queries
Name 104123 0
Prof Richard Bryant
Address 104123 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 104123 0
Australia
Phone 104123 0
+61293853640
Fax 104123 0
+61293853641
Email 104123 0
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 104124 0
Prof Richard Bryant
Address 104124 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 104124 0
Australia
Phone 104124 0
+61293853640
Fax 104124 0
+61293853641
Email 104124 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?
All treatment-related data, assessment data, and related data dictionaries will be 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?
Meta-analyses 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