Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000437864
Ethics application status
Approved
Date submitted
12/04/2012
Date registered
18/04/2012
Date last updated
4/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Living with deadly thoughts: Reducing suicidal thoughts through a web-based self-help intervention.
Scientific title
A pilot study to investigate the feasibility of a web-based self-help program to reduce suicidal thoughts in community members with suicidal thoughts.
Secondary ID [1] 280308 0
Nil
Universal Trial Number (UTN)
U1111-1129-8661
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal thoughts 286267 0
Condition category
Condition code
Mental Health 286488 286488 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The active intervention is a web-based self-help program for suicidal thoughts. This program is based on cognitive behaviour therapy and consists of six modules that focus on 1) the repetitive character of suicidal thoughts, 2) regulating intense emotions, 3) identifying automatic thoughts, 4) recognising thinking patterns, 5) thought challenging, and 6) relapse prevention. Participants will be encouraged to complete one module per week, which will take up to a maximum of 15 minutes per day.
Intervention code [1] 284658 0
Prevention
Intervention code [2] 284695 0
Behaviour
Comparator / control treatment
The control group is matched for attention by providing a web-based 6-week program that presents ‘lifestyle’ information on nutrition; physical and artistic activities; education; hobbies; finances; and social and family roles. There is no specific mental health or suicide-related content in this program. The control condition is matched for attention by providing interactive activities of the same duration as the intervention group, i.e. 15 minutes per day.
Control group
Active

Outcomes
Primary outcome [1] 286931 0
The primary outcome of this pilot is the feasibility of a larger randomized controlled trial.
This will be assessed by examining the adherence to the program, study dropout rates, and acceptability of the program.
Timepoint [1] 286931 0
Evaluation of primary outcome 1 will take place at the end of the program, i.e. 6 weeks after commencement.
Primary outcome [2] 286972 0
Investigating all trial mechanisms.
This will include testing the recruitment method by simple counts of applications through the different methods; testing the screening procedure by examining the number of respondents excluded due to each of the exclusion criteria; and testing the use of self-report questionnaires by analysing trends from pretest to posttest on suicidal thoughts, depression, anxiety, panic, coping, insomnia, rumination, hopelessness, burdensomeness and belongingness, disability, help-seeking, health care utilisation, and health status.
Timepoint [2] 286972 0
Evaluation of primary outcome 2 will take place at the end of the program, i.e. 6 weeks after commencement.
Primary outcome [3] 286973 0
Testing the web-programs and safety procedures.
The programs will be assessed by looking at usage data, such as number of modules and exercises completed, as well as by analysing feedback from participants about the program. In the case of safety procedures, the proportion of participants referred to crisis services who ultimately utilise these services will be calculated, giving an indication of the applicability and utility of these procedures.
Timepoint [3] 286973 0
Evaluation of primary outcome 3 will take place at the end of the program, i.e. 6 weeks after commencement.
Secondary outcome [1] 297012 0
None
Timepoint [1] 297012 0
None

Eligibility
Key inclusion criteria
Not be severely depressed, defined as a score between 0 and 20 on the Patient Health Questionnaire 9 (PHQ-9); experience some suicidal thoughts, defined as endorsing >0 PHQ-9 item 9; not be actively suicidal, defined as endorsing ‘yes’ on any of four intent questions; aged 18-25; have a valid email address; have reliable internet access; proficiency with reading English, currently living in Australia.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe depression, defined as a score >20 on the Patient Health Questionnaire-9 (PHQ-9); no suicidal thoughts, defined as endorsing PHQ-9 item 9 as ‘0’; be actively suicidal, defined as endorsing ‘yes’ on any of four intent questions; ever having been diagnosed with a psychotic disorder such as schizophrenia, aged <18 or >25.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random allocation is concealed by using automated computer-based randomisation procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once participants have given their consent and have filled in the baseline questionnaire, they are randomised to either the active or the control intervention, using block randomisation, stratified by gender and severity of suicidal thoughts. The latter is defined as a score > 7 on the Suicidal Behaviour Questionnaire-Revised.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2012
Actual
20/12/2012
Date of last participant enrolment
Anticipated
Actual
22/03/2013
Date of last data collection
Anticipated
Actual
2/05/2013
Sample size
Target
50
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 285077 0
Charities/Societies/Foundations
Name [1] 285077 0
Australian Rotary Health
Country [1] 285077 0
Australia
Primary sponsor type
Individual
Name
Professor Helen Christensen
Address
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 283941 0
Individual
Name [1] 283941 0
Professor Kathy Griffiths
Address [1] 283941 0
Centre for Mental Health Research
Building 63, Eggleston Road
The Australian National University
Canberra ACT 0200
Country [1] 283941 0
Australia
Other collaborator category [1] 260721 0
Individual
Name [1] 260721 0
Bregje van Spijker
Address [1] 260721 0
Centre for Mental Health Research
Building 63, Eggleston Road
The Australian National University
Canberra ACT 0200
Country [1] 260721 0
Australia
Other collaborator category [2] 260722 0
Individual
Name [2] 260722 0
Julia Reynolds
Address [2] 260722 0
Centre for Mental Health Research
Building 63, Eggleston Road
The Australian National University
Canberra ACT 0200
Country [2] 260722 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287091 0
University of New South Wales HREC
Ethics committee address [1] 287091 0
Ethics committee country [1] 287091 0
Australia
Date submitted for ethics approval [1] 287091 0
20/04/2012
Approval date [1] 287091 0
27/07/2012
Ethics approval number [1] 287091 0
HC12245

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

Contacts
Principal investigator
Name 34051 0
Prof Helen Christensen
Address 34051 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 34051 0
Australia
Phone 34051 0
+61 02 9382 9288
Fax 34051 0
Email 34051 0
[email protected]
Contact person for public queries
Name 17298 0
Professor Helen Christensen
Address 17298 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 17298 0
Australia
Phone 17298 0
+61 2 9382 9288
Fax 17298 0
+61 2 9382 8208
Email 17298 0
[email protected]
Contact person for scientific queries
Name 8226 0
Professor Helen Christensen
Address 8226 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 8226 0
Australia
Phone 8226 0
+61 2 9382 9288
Fax 8226 0
+61 2 9382 8208
Email 8226 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.