Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000877189
Ethics application status
Approved
Date submitted
4/06/2019
Date registered
20/06/2019
Date last updated
4/12/2020
Date data sharing statement initially provided
20/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A mental health informed physical activity program for first responders and their chosen support partners
Scientific title
The effect of a physical activity program for first responders and their chosen support partners on psychological distress
Secondary ID [1] 298415 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness 313132 0
Physical inactivity 313133 0
Condition category
Condition code
Mental Health 311606 311606 0 0
Depression
Mental Health 311607 311607 0 0
Anxiety
Mental Health 311608 311608 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 311713 311713 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will recruit sedentary first responders and their chosen support partner to a 10-week, group based physical activity intervention delivered online through a private Facebook group.
All of the content for the current intervention has been informed based on the results and feedback from our pilot intervention. The research team will provide education on pre-determined weekly topics and facilitate discussion boards, e.g. goal setting, barriers and sedentary behaviour. Weekly content will include information, links to youtube videos, links to existing online recourses, images, step count competitions and discussion questions. These posts will all occur from the study generated account and the page will be checked by the facilitators at least once per day; Monday to Friday. Defined behaviour change techniques such as informing the behaviour-health link, barrier identification, general encouragement, instruction, self-monitoring, social support, specific goal setting and feedback will be incorporated into the program.

Participants will also have the option to join a weekly group telehealth call. The facilitator will lead the discussion on the weekly topic for approximately 20 minutes and participants will be able to join in on the discussion and ask questions.

There will be a follow up period of one month as well as month of data collection prior to the intervention where participants will just be required to complete questionnaires to obtain baseline data. This interrupted time series design will replace the need for a control group.

The iterative development of this intervention has occurred through collaboration with project advisors with lived experience of working as a first responder, and of living with mental illness related to occupational trauma. They will act as peer support within the Facebook group, while the researchers (exercise physiologists, psychologists and a dietitian) will guide the group. In addition, two to three volunteers from the previous iterations of the program will be invited to the Facebook group to also act as peer support members. Their role will be to help deliver content and share their personal experiences with the program, bridging the gap between participants and facilitators.
Intervention code [1] 314666 0
Treatment: Other
Intervention code [2] 314667 0
Prevention
Intervention code [3] 314668 0
Lifestyle
Comparator / control treatment
The step wedge design replaces the need for a control group by making each participant act as its own comparison prior to implementation. The different baseline lengths will range from 2 to 5 weeks. During this phase participants will have no intervention. They will just be asked weekly questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 320309 0
Psychological distress -Kessler6
Timepoint [1] 320309 0
The K6 will be assessed every week from baseline, weeks 1-10 of the intervention and 4 weeks post intervention. We will determine the difference in slope between pre, during and post intervention.
Secondary outcome [1] 371178 0
Minutes of physical activity- composite secondary outcome
1) Physical activity vital sign
2) Simple Physical Activity Questionnaire (SIMPAQ)
3) FitBit accelerometry data (active minutes and daily steps)
Timepoint [1] 371178 0
1) Assessed weekly throughout baseline, intervention and follow up (every week from baseline, weeks 1-10 of the intervention and 4 weeks post intervention).
2) Baseline, post-intervention and follow up (weeks 1, 10 and 4 weeks post intervention)
3) Weekly throughout the intervention and follow up period. (weeks 1-10 and 4 weeks post intervention)
Secondary outcome [2] 371179 0
Depression and anxiety stress scale (DASS-21)
Timepoint [2] 371179 0
It will be assessed at baseline, post-intervention and follow up (weeks 1, 10 and 4 weeks post).
Secondary outcome [3] 371180 0
Posttraumatic Stress Disorder Symptoms (PCL-5)
* first-responders only
Timepoint [3] 371180 0
It will be assessed at baseline, post-intervention and follow up (weeks 1, 10 and 4 weeks post).
Secondary outcome [4] 371181 0
Sleep quality (PSQI)
Timepoint [4] 371181 0
It will be assessed at baseline, post-intervention and follow up (weeks 1, 10 and 4 weeks post).
Secondary outcome [5] 371182 0
Quality of life (Aqol-6D)
Timepoint [5] 371182 0
It will be assessed at baseline, post-intervention and follow up (weeks 1, 10 and 4 weeks post).
Secondary outcome [6] 371183 0
Social support for exercise survey- Sallis et al.
Timepoint [6] 371183 0
It will be assessed at baseline, post-intervention and follow up (weeks 1, 10 and 4 weeks post).
Secondary outcome [7] 371184 0
The suicidal ideation attributes scale (SIDAS)
Timepoint [7] 371184 0
It will be assessed at weeks baseline, post-intervention and follow up (weeks 1, 10 and 4 weeks post).
Secondary outcome [8] 371185 0
Feasibility will be defined by usage of the Facebook group (manual calculation of the sum of posts, likes, and comments), FitBit compliance (% of days worn) and participant retention (completion of questionnaires and retention in program).
Timepoint [8] 371185 0
Post intervention (week 10)
Secondary outcome [9] 371493 0
Acceptability will be assessed at post-intervention using the 14-item feasibility and acceptability questionnaire that has been used previously to measure participant responses to a private Facebook group.. Participants will also be invited to participate in a 20 minute one-on-one semi-structured interview via Skype. The interview will cover topics such as likes, dislikes, effectiveness and recommendations for future iterations. Interviews will be recorded and transcribed verbatim. They will then be qualitatively analysed using thematic analysis to determine key themes identified by participants
Timepoint [9] 371493 0
Post intervention (week 10)

Eligibility
Key inclusion criteria
This research study is looking to recruit a convenience sample of i) former or current first responders, ii) aged 18-65 years, iii) currently inactive defined as engaging in less than 150 mins per week of moderate-vigorous physical activity per week, iv) cleared to participate in an exercise program (absence of any American College of Sports Medicine (ACSM) absolute contraindications to exercise participation). Participants must also speak English, have internet access and an active Facebook account or be willing to create one.
First responders must also nominate their support partner who may be any person with a close personal relationship to them eg. partner, family member, friend who have at least weekly in-person contact with each other. This person must also be between 18-65 years and be medically absent from any ACSM absolute contraindications to exercise.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Although we will not specifically target those first responders with a diagnosed mental disorder, by nature of the target population, it is expected that a high proportion of the participants will be receiving treatment for a mental disorder. Severely depressed individuals or those experiencing frequent suicidal ideation at the outset will be excluded from the study and directed towards appropriate services in their community. Participants will be screened prior to commencement of the study and those who receive a score of >25 suggests the person is likely to have a severe mental disorder. Participants who score >25 and who are not receiving treatment or whose medications have changed in the past 4 weeks will be excluded and referred to a local health professional.

Participants will also be screened with the physical activity vital sign and the ESSA pre-screening tool. First-responders who exceed 150mins of moderate-vigorous PA will be excluded and those who answer yes to any of the 7 ESSA pre-screening questions must get clearance to exercise from a general practitioner.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
This study will apply a step wedge design. This involves the collection of data on multiple occasions before the intervention to detect whether the intervention has an effect significantly greater than the underlying secular trend. Consecutive observations will be interrupted by the intervention to see if the slope or level of the series changes following the intervention. The baseline lengths of each group taken through the program will be randomised between two and five weeks so that treatment is introduced at different times for each cohort. A random number generator was used in excel to generate values between 0 and 1. This was then used to order the length of baseline into a random order.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/06/2019
Date of last participant enrolment
Anticipated
21/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 302963 0
Self funded/Unfunded
Name [1] 302963 0
NA
Country [1] 302963 0
Primary sponsor type
University
Name
UNSW
Address
UNSW Sydney, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 302920 0
None
Name [1] 302920 0
NA
Address [1] 302920 0
NA
Country [1] 302920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303517 0
The University of New South Wales Research Ethics Committee: DVCR RECS Human Ethics
Ethics committee address [1] 303517 0
Ethics committee country [1] 303517 0
Australia
Date submitted for ethics approval [1] 303517 0
Approval date [1] 303517 0
03/06/2019
Ethics approval number [1] 303517 0
HC180561

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

Contacts
Principal investigator
Name 93938 0
Miss Grace McKeon
Address 93938 0
UNSW AGSM Building, Botany St, Randwick NSW 2031
Country 93938 0
Australia
Phone 93938 0
+61 434041357
Fax 93938 0
Email 93938 0
[email protected]
Contact person for public queries
Name 93939 0
Grace McKeon
Address 93939 0
UNSW AGSM Building, Botany St, Randwick NSW 2031
Country 93939 0
Australia
Phone 93939 0
+61 434041357
Fax 93939 0
Email 93939 0
[email protected]
Contact person for scientific queries
Name 93940 0
Grace McKeon
Address 93940 0
UNSW AGSM Building, Botany St, Randwick NSW 2031
Country 93940 0
Australia
Phone 93940 0
+61 434041357
Fax 93940 0
Email 93940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data may be easily identifiable by those within the same intervention group based on their physical activity levels, occupation, age etc.


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
EmbaseMental health informed physical activity for first responders and their support partner: A protocol for a stepped-wedge evaluation of an online, codesigned intervention.2019https://dx.doi.org/10.1136/bmjopen-2019-030668
N.B. These documents automatically identified may not have been verified by the study sponsor.