Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000811909
Ethics application status
Approved
Date submitted
7/08/2020
Date registered
13/08/2020
Date last updated
12/04/2023
Date data sharing statement initially provided
13/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a Brief Mood Training Program on Anxiety and Depression Arising from COVID-19-Related Stress
Scientific title
Randomised Controlled Trial of Positive Mood Training versus Enhanced Treatment as Usual on Anxiety and Depression in People Distressed by COVID-19
Secondary ID [1] 301966 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 318524 0
Anxiety 318525 0
COVID-19 318526 0
Condition category
Condition code
Mental Health 316527 316527 0 0
Depression
Mental Health 316528 316528 0 0
Anxiety
Infection 316529 316529 0 0
Other infectious diseases
Respiratory 316530 316530 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: Positive Mood Training. Arm 2: Enhanced Treatment as Usual. Therapy is administered once-weekly 60 minute sessions by clinical psychologists over 7 weeks delivered via video-conferencing to groups of 4 people at a time. Across sessions the clinical psychologist will teach the following mood coping strategies: arousal reduction, mood improvement strategies, positive events boosting, and accessing social support. This will occur will via educational sessions, group discussions via teleconference, and homework assignments. Homework will include mood monitoring, prompts to engage in positive activities, and prompts to engage in social interaction. Adherence to session strategies and homework assignments will be monitored by completing session attendance checklists and weekly checks of assigned homework tasks. Clinical psychologists will be trained by the lead investigator (Bryant), and will be supplemented by completion of conducting practice groups under supervision. Participants who complete all assessments will be reimbursed $50 for their time. The duration of the study for any participant will conclude after a 3-month follow-up assessment, resulting in participation duration of 20 weeks.
Intervention code [1] 318254 0
Behaviour
Intervention code [2] 318255 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 Positive Mood Training condition but participants will be encouraged to practice the strategies for 7 weeks. These strategies will be emailed to participants, and will comprise instructions in arousal reduction, mood improvement strategies, positive events boosting, and accessing social support. The duration of the study for any participant will conclude after a 3-month follow-up assessment, resulting in participation duration of 20 weeks.
Control group
Active

Outcomes
Primary outcome [1] 324659 0
Anxiety and depression represent a composite primary outcome, as measured by the Hospital Anxiety and Depression scale.
Timepoint [1] 324659 0
Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 20).
Secondary outcome [1] 385347 0
Worry as measured by the Generalized Anxiety DIsorder 7.
Timepoint [1] 385347 0
Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 20).
Secondary outcome [2] 385348 0
Suicidal ideation as measured by the Suicide Attribute Scale.
Timepoint [2] 385348 0
Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 20).
Secondary outcome [3] 385349 0
Positive and negative affect as measured by the Positive and Negative Affect Scale.
Timepoint [3] 385349 0
Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 20).
Secondary outcome [4] 385350 0
Health related quality of life will be measured using Australian Quality of Life.
Timepoint [4] 385350 0
Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 20).
Secondary outcome [5] 402472 0
Sleep difficulties as measured by the Sleep Impairment Index.
Timepoint [5] 402472 0
Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 20).
Secondary outcome [6] 402473 0
Pandemic related concerns as measured by the Coronavirus Concerns Scale.
Timepoint [6] 402473 0
Pretreatment (week 1), posttreatment (week 7), primary follow-up (week 20).

Eligibility
Key inclusion criteria
Inclusion Criteria:
• Score of greater than or equal to 16 on K10
• 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
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 follow-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 3 months assessment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2020
Actual
4/01/2021
Date of last participant enrolment
Anticipated
29/01/2021
Actual
24/09/2021
Date of last data collection
Anticipated
8/02/2022
Actual
18/02/2022
Sample size
Target
176
Accrual to date
Final
174
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306389 0
Government body
Name [1] 306389 0
NHMRC
Country [1] 306389 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Anzac Pde, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 306892 0
None
Name [1] 306892 0
NA
Address [1] 306892 0
NA
Country [1] 306892 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306588 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 306588 0
Ethics committee country [1] 306588 0
Australia
Date submitted for ethics approval [1] 306588 0
28/04/2020
Approval date [1] 306588 0
18/09/2020
Ethics approval number [1] 306588 0
HC200670

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104382 0
Prof Richard Bryant
Address 104382 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 104382 0
Australia
Phone 104382 0
+61293853640
Fax 104382 0
+61293853641
Email 104382 0
[email protected]
Contact person for public queries
Name 104383 0
Richard Bryant
Address 104383 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 104383 0
Australia
Phone 104383 0
+61293853640
Fax 104383 0
+61293853641
Email 104383 0
[email protected]
Contact person for scientific queries
Name 104384 0
Richard Bryant
Address 104384 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 104384 0
Australia
Phone 104384 0
+61293853640
Fax 104384 0
+61293853641
Email 104384 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?
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: [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
No additional documents have been identified.