Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001477314
Ethics application status
Approved
Date submitted
16/10/2017
Date registered
19/10/2017
Date last updated
19/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the effectiveness of coping planning in reducing distress in university students
Scientific title
A randomised controlled trial evaluating the effectiveness of coping planning in reducing distress in university students
Secondary ID [1] 293138 0
"None"
Universal Trial Number (UTN)
'None'
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 305111 0
Condition category
Condition code
Mental Health 304423 304423 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The online program, Coping, available at, https://e.unisa.edu.au/course/view.php?id=38. The program, based on the Coping Planning approach to suicide prevention, comprises two self-paced online modules (Self-care and problem-solving) that are completed sequentially. The modules include videos, text, videos and online activities to promote learning. The modules can be completed in one sitting or over a period of a week. The estimated time to complete the program is one hour. The program is based on the Coping Planning approach to suicide prevention (Stallman, 2017).. Participants receive a Completion Certificate after all learning activities are completed. The certificate will be emailed to the research team as evidence of completion. Partial completion is assessed using program analytics.

Reference
Stallman, H. M. (2017). Coping Planning: A patient- and strengths-focused approach to suicide prevention training. Australasian Psychiatry. Advance online doi: https://doi.org/10.1177/1039856217732471
Intervention code [1] 299388 0
Treatment: Other
Intervention code [2] 299389 0
Lifestyle
Comparator / control treatment
thedesk www.thedesk.org,; an unstructured online program with quizzes, modules and tools to improve university student health and wellbeing. Participants in thedesk condition are requested to spend one hour doing the program over the course of one week, roughly equivalent to the time required to complete the intervention program.
Control group
Active

Outcomes
Primary outcome [1] 303660 0
Psychological distress using the K10
Timepoint [1] 303660 0
2 weeks post-baseline assessment
Primary outcome [2] 303685 0
Disability using the K10 disability questions

1. In the last 2 weeks, HOW MANY DAYS were you TOTALLY UNABLE to work, study or manage your day to day activities because of these feelings?

2. Aside from those days, in the last 2 weeks, HOW MANY DAYS were you able to work or study or manage your day to day activities, but had to CUT DOWN on what you did because of these feelings?
Timepoint [2] 303685 0
Two weeks post-baseline
Secondary outcome [1] 339803 0
Coping self-efficacy using the Coping Self-efficacy Scale
Timepoint [1] 339803 0
2 weeks post-baseline assessment
Secondary outcome [2] 339841 0
Coping using the Brief Cope questionnaire
Timepoint [2] 339841 0
Two weeks post-baseline
Secondary outcome [3] 339842 0
Participant satisfaction using an open question "How useful did you find the program?"
Timepoint [3] 339842 0
Two weeks post-baseline

Eligibility
Key inclusion criteria
Student enrolled at the University of South Australia
Psychological distress score of 16 or higher on the K10
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No

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)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
A total of 229 students will be recruited to be able to detect a medium effect size (d = .5) in reduced distress with power of .95 and an attrition rate of 30%.

Data will be analysed using ANCOVAs with baseline data used as covariates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/10/2017
Actual
Date of last participant enrolment
Anticipated
27/11/2017
Actual
Date of last data collection
Anticipated
11/12/2017
Actual
Sample size
Target
229
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 17839 0
5000 - Adelaide
Recruitment postcode(s) [2] 17840 0
5072 - Magill
Recruitment postcode(s) [3] 17841 0
5095 - Mawson Lakes

Funding & Sponsors
Funding source category [1] 297763 0
University
Name [1] 297763 0
University of South Australia
Country [1] 297763 0
Australia
Primary sponsor type
Individual
Name
Dr Helen Stallman
Address
School of Psychology, Social Work and Social Policy
University of South Australia
GPO Box 2471, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 296802 0
None
Name [1] 296802 0
Address [1] 296802 0
Country [1] 296802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298826 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 298826 0
Ethics committee country [1] 298826 0
Date submitted for ethics approval [1] 298826 0
11/10/2017
Approval date [1] 298826 0
16/10/2017
Ethics approval number [1] 298826 0
200571

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

Contacts
Principal investigator
Name 78358 0
Dr Helen Stallman
Address 78358 0
School of Psychology, Social Work and Social Policy
University of South Australia
GPO Box 2471, Adelaide SA 5001
Country 78358 0
Australia
Phone 78358 0
+61 8 8302 4360
Fax 78358 0
Email 78358 0
[email protected]
Contact person for public queries
Name 78359 0
Helen Stallman
Address 78359 0
School of Psychology, Social Work and Social Policy
University of South Australia
GPO Box 2471, Adelaide SA 5001
Country 78359 0
Australia
Phone 78359 0
+61883024360
Fax 78359 0
Email 78359 0
[email protected]
Contact person for scientific queries
Name 78360 0
Helen Stallman
Address 78360 0
School of Psychology, Social Work and Social Policy
University of South Australia
GPO Box 2471, Adelaide SA 5001
Country 78360 0
Australia
Phone 78360 0
+61883024360
Fax 78360 0
Email 78360 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.