Trial Review

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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
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 6-month follow-up assessment, resulting in participation duration of 33 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 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] 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), additional follow-up (week 33).
Secondary outcome [1] 381569 0
Worry as measured by the Generalized Anxiety DIsorder 7.
Timepoint [1] 381569 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), and additional follow-up (week 33).
Secondary outcome [2] 381570 0
Sleep difficulties as measured by the Sleep Impairment Index.
Timepoint [2] 381570 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), additional follow-up (week 33).
Secondary outcome [3] 391484 0
Positive affect as measured by the Pleasure Scale.
Timepoint [3] 391484 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), additional follow-up (week 33)
Secondary outcome [4] 391485 0
Affective state as measured by the Positive and Negative Affect Scale.
Timepoint [4] 391485 0
Pretreatment (week 1), posttreatment (week 7), follow-up (week 15), additional follow-up (week 33)
Secondary outcome [5] 391486 0
Worries about COVID-19 as measured by the COVID-19 Stress Scale.
Timepoint [5] 391486 0
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?
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
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] 305305 0
Government body
Name [1] 305305 0
NHMRC
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
Approved
Ethics committee name [1] 305644 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 305644 0
Ethics committee country [1] 305644 0
Australia
Date submitted for ethics approval [1] 305644 0
30/03/2020
Approval date [1] 305644 0
03/05/2020
Ethics approval number [1] 305644 0

Summary
Brief summary
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
[email protected]
Contact person for public queries
Name 101067 0
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
[email protected]
Contact person for scientific queries
Name 101068 0
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
[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 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: [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
EmbaseBrief videoconferencing psychological intervention for reducing COVID-19 related distress: study protocol for a randomized controlled trial.2021https://dx.doi.org/10.1186/s12889-021-10529-x
N.B. These documents automatically identified may not have been verified by the study sponsor.