Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001637336
Ethics application status
Approved
Date submitted
20/11/2017
Date registered
18/12/2017
Date last updated
18/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A controlled trial evaluation of the Australian National University Counselling Centre's 'Get Up & Go' peer-support walking program on interpersonal suicide risk and wellbeing in students
Scientific title
The effects of a peer-support walking program on interpersonal suicide risk and wellbeing in university students: A controlled trial
Secondary ID [1] 293404 0
Nil known
Universal Trial Number (UTN)
U1111-1205-4458
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interpersonal suicide risk 305552 0
Connectedness 305553 0
Wellbeing 305554 0
Mental health 305555 0
Condition category
Condition code
Mental Health 304779 304779 0 0
Suicide
Mental Health 304780 304780 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Peer-support walking program

‘Get Up & Go’ is a peer-support walking program run by the Australian National University (ANU) Counselling Centre since 2006. The program aims to promote student mental health and wellbeing by providing ANU students with regular opportunities for physical activity and social contact – two recognised protective factors for depression. Participants comprise both undergraduate and postgraduate ANU students who register their interest in participating as a walking partner in the program each semester. Motivations for involvement have included social reasons, health and exercise reasons, improving or managing mood, or developing English skills and social networks. The program links participating students together as walking partners and walks are arranged between the students to take place on a weekly basis at a mutually convenient time and place. The intervention period runs for one university semester, where it is recommended that students walk for at least an hour a week, with walks taking place on weekdays, during daylight hours, and on or around the ANU campus. Participants are encouraged to keep up the exercise component of the program (as opposed to social only), and move onto other exercise activities at the program’s completion at the end of the semester. Intervention adherence was assessed by the primary researcher via dosage questions administered in the intervention group's post-assessment survey. Email reminders sent by the primary researcher to study participants were used as a strategy to maintain fidelity.
Intervention code [1] 299646 0
Lifestyle
Intervention code [2] 299647 0
Prevention
Comparator / control treatment
Waitlist control group that received baseline and post-assessments prior to intervention commencement. For ethical reasons, the waitlist control group received the intervention post-assessment.
Control group
Active

Outcomes
Primary outcome [1] 304004 0
Mean levels of interpersonal suicide risk assessed by the Interpersonal Needs Questionnaire-15 (composite measure for both thwarted belongingness and perceived burdensomeness).
Timepoint [1] 304004 0
Waitlist control group: Baseline assessment administered 6 weeks before intervention commencement and post assessment 2 weeks before intervention commencement.

Intervention group: Baseline assessment administered 2 weeks before the intervention commencement and post assessment 10 weeks after intervention commencement.
Primary outcome [2] 304005 0
Mean levels of interpersonal suicide risk assessed by the newly developed 8 item thwarted belongingness scale and self-hatred scale (treated as composite measure for both thwarted belongingness and perceived burdensomeness).
Timepoint [2] 304005 0
Waitlist control group: Baseline assessment administered 6 weeks before intervention commencement and post assessment 2 weeks before intervention commencement.

Intervention group: Baseline assessment administered 2 weeks before the intervention commencement and post assessment 10 weeks after intervention commencement.
Secondary outcome [1] 340705 0
Mean levels of wellbeing measured by the WHO-5 well-being index
Timepoint [1] 340705 0
Waitlist control group: Baseline assessment administered 6 weeks before intervention commencement and post assessment 2 weeks before intervention commencement.

Intervention group: Baseline assessment administered 2 weeks before the intervention commencement and post assessment 10 weeks after intervention commencement.
Secondary outcome [2] 340940 0
Mean levels of social support measured by the Schuster Social Support Scale.
Timepoint [2] 340940 0
Waitlist control group: Baseline assessment administered 6 weeks before intervention commencement and post assessment 2 weeks before intervention commencement.

Intervention group: Baseline assessment administered 2 weeks before the intervention commencement and post assessment 10 weeks after intervention commencement.
Secondary outcome [3] 340941 0
Mean levels of school membership measured by the Brief Psychological Sense of School Membership Scale
Timepoint [3] 340941 0
Waitlist control group: Baseline assessment administered 6 weeks before intervention commencement and post assessment 2 weeks before intervention commencement.

Intervention group: Baseline assessment administered 2 weeks before the intervention commencement and post assessment 10 weeks after intervention commencement.
Secondary outcome [4] 340942 0
Mean levels of resilience measured by the CD-RISC
Timepoint [4] 340942 0
Waitlist control group: Baseline assessment administered 6 weeks before intervention commencement and post assessment 2 weeks before intervention commencement.

Intervention group: Baseline assessment administered 2 weeks before the intervention commencement and post assessment 10 weeks after intervention commencement.
Secondary outcome [5] 341154 0
Participant feedback regarding the 'Get Up & Go' peer-support walking program measured by a series of closed and open-ended questions.
Timepoint [5] 341154 0
Intervention group: Post assessment 10 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Undergraduate and postgraduate students who have registered to take part in the 'Get Up & Go's' Semester 2 cohort.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not a student at the Australian National University

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants received the same intervention throughout the study. However, the waitlist control group received pre and post assessments prior to intervention commencement, while the intervention group received assessments pre and post intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proposed number of participants is 120. Participants were chosen because they represent the typical number who have registered to take part in the 'Get Up and Go' peer-support walking program at the ANU Counselling Centre. With 80% consent and completion, this sample size will be sufficient to detect a moderate effect between the two groups (f=0.25) with 80% power.

Linear mixed models will be employed to examine the effectiveness of the 'Get Up & Go' peer-support walking program compared to a waitlist control condition in contributing to decreased levels of interpersonal suicide risk, depression symptoms and psychological distress, and increased levels of social support, school membership, wellbeing, and resilience in participating students at the Australian National University (ANU). Participant engagement, adherence, use, and satisfaction with the 'Get Up & Go'
peer-support walking program with be assessed qualitatively in the intervention group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/07/2017
Date of last participant enrolment
Anticipated
Actual
18/08/2017
Date of last data collection
Anticipated
Actual
17/11/2017
Sample size
Target
120
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 18128 0
2601 - Canberra

Funding & Sponsors
Funding source category [1] 298025 0
Government body
Name [1] 298025 0
ANU / NHMRC Centre for Research Excellence in Suicide Prevention PhD Scholarship
Country [1] 298025 0
Australia
Primary sponsor type
Individual
Name
Jennifer Ma
Address
Centre for Mental Health Research, 63 Eggleston Road, The Australian National University, Canberra ACT 2601 AUSTRALIA.
Country
Australia
Secondary sponsor category [1] 297102 0
Individual
Name [1] 297102 0
Philip Batterham
Address [1] 297102 0
Centre for Mental Health Research, 63 Eggleston Road, The Australian National University, Canberra ACT 2601 AUSTRALIA.
Country [1] 297102 0
Australia
Other collaborator category [1] 279821 0
Individual
Name [1] 279821 0
Alison Calear
Address [1] 279821 0
Centre for Mental Health Research, 63 Eggleston Road, The Australian National University, Canberra ACT 2601 AUSTRALIA.
Country [1] 279821 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299058 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 299058 0
Ethics committee country [1] 299058 0
Australia
Date submitted for ethics approval [1] 299058 0
27/03/2017
Approval date [1] 299058 0
26/04/2017
Ethics approval number [1] 299058 0
2017/242

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

Contacts
Principal investigator
Name 79142 0
Ms Jennifer Ma
Address 79142 0
Centre for Mental Health Research, 63 Eggleston Road, The Australian National University, Canberra ACT 2601
Country 79142 0
Australia
Phone 79142 0
+61 2 6125 6370
Fax 79142 0
+61 2 6125 0733
Email 79142 0
[email protected]
Contact person for public queries
Name 79143 0
Jennifer Ma
Address 79143 0
Centre for Mental Health Research, 63 Eggleston Road, The Australian National University, Canberra ACT 2601
Country 79143 0
Australia
Phone 79143 0
+61 410 856 071
Fax 79143 0
Email 79143 0
[email protected]
Contact person for scientific queries
Name 79144 0
Jennifer Ma
Address 79144 0
Centre for Mental Health Research, 63 Eggleston Road, The Australian National University, Canberra ACT 2601
Country 79144 0
Australia
Phone 79144 0
+61 410 856 071
Fax 79144 0
Email 79144 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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