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Trial registered on ANZCTR


Registration number
ACTRN12613000410752
Ethics application status
Approved
Date submitted
11/04/2013
Date registered
15/04/2013
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Thinking Project: A randomised controlled trial of a web-based self-help program to reduce suicide ideation
Scientific title
A randomised controlled trial comparing a web-based self-help program to reduce suicide ideation with an attention matched control program in community members with suicide ideation
Secondary ID [1] 282278 0
NHMRC project grant GNT1046317
Universal Trial Number (UTN)
U1111-1141-6595
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicidal thoughts 288815 0
Condition category
Condition code
Mental Health 289174 289174 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. Adherence to the program will be monitored by looking at number of modules and exercises completed.
Intervention code [1] 286908 0
Prevention
Intervention code [2] 286909 0
Treatment: Other
Intervention code [3] 286910 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; maintaining a healthy environment; preventing heart disease; maintaining a healthy weight; common skin problems; and oral hygiene. 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] 289285 0
suicidal thoughts (C-SSRS)
Timepoint [1] 289285 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [1] 302152 0
Depression (CES-D)
Timepoint [1] 302152 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [2] 302153 0
Hopelessness (HS)
Timepoint [2] 302153 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [3] 302154 0
Reasons for Living (BRFL, 'survival and coping beliefs' factor)
Timepoint [3] 302154 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [4] 302155 0
Anxiety (GAD-7)
Timepoint [4] 302155 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [5] 302156 0
Panic syndrome (Brief PHQ, panic syndrome subscale)
Timepoint [5] 302156 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [6] 302157 0
Alcohol use (AUDIT-C)
Timepoint [6] 302157 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [7] 302158 0
Insomnia (ISI)
Timepoint [7] 302158 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [8] 302159 0
Rumination (RSS)
Timepoint [8] 302159 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [9] 302160 0
Belongingness and perceived burdensomeness (INQ)
Timepoint [9] 302160 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [10] 302161 0
Acquired capability for suicide (ACSS)
Timepoint [10] 302161 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [11] 302162 0
Health and disability (WHODAS-II)
Timepoint [11] 302162 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [12] 302163 0
Health care utilization (CSRI)
Timepoint [12] 302163 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [13] 302164 0
Health status (SF-12)
Timepoint [13] 302164 0
Baseline, 6-week post-test, 6-month follow-up, 12-month follow-up
Secondary outcome [14] 302165 0
Help seeking (GHSQ)
Timepoint [14] 302165 0
Baseline
Secondary outcome [15] 302166 0
Evaluation and utility of website (IEUQ)
Timepoint [15] 302166 0
6-week post-test

Eligibility
Key inclusion criteria
Currently experiencing suicidal thoughts; not having attempted suicide in the past month; being 18-65 years old; having a valid email address; having reliable internet access; being proficient with reading English, not having been diagnosed with a psychotic disorder; currently living in Australia.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not experiencing suicidal thoughts; having attempted suicide in the past month; having been diagnosed with a psychotic disorder; being younger than 18 or older than 65 years old.

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)
Enrollment occurs online. Respondents follow an online screening procedure to determine eligiblity. If deemed eligible, they are provided with the participant information statement and subsequently the online informed consent form. After giving consent, they are asked to login and fill in the baseline questionnaires, after which they are randomised to the active or the control condition by the system. 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)
Randomisation occurs in blocks (4 per block), and stratified by gender and severity of suicidal thoughts. The latter is defined as endorsing ‘yes’ on item 5 of the ‘suicidal ideation’ section of the C-SSRS.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power to detect change in suicidal thoughts is based on the expected effect of the intervention on the primary outcome measure. Based on the findings from the Dutch trial on which this trial is based, the expected effect size is 0.30 (Cohen’s d). To be able to detect this effect size, assuming a correlation between pre- and post-test measures of .5, including an expected drop-out rate of 30%, and allowing a width of about +/-.20 for the Confidence Intervals of the effect size, 285 starters (200 completers) would be needed in each condition (with alpha=0.05 and power of 0.80). The aim is therefore to include 570 participants in the trial.

Analyses of continuous measures will be undertaken on an intent-to-treat basis, including all participants randomized regardless of treatment actually received or withdrawal from the study. Mixed-model repeated measures (MMRM) analyses will be used as this approach provides an intent-to-treat analysis including all available data from participants under the missing at random assumption rather than excluding those with missing data or using biased techniques such as last observation carried forward. Potential moderators of outcome such as gender and age will be explored and controlled for in the analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2013
Actual
19/11/2013
Date of last participant enrolment
Anticipated
Actual
31/12/2015
Date of last data collection
Anticipated
Actual
31/12/2016
Sample size
Target
570
Accrual to date
Final
418
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287050 0
Government body
Name [1] 287050 0
National Health and Medical Research Council
Country [1] 287050 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] 285824 0
Individual
Name [1] 285824 0
Dr Bregje van Spijker
Address [1] 285824 0
Black Dog Institute,
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country [1] 285824 0
Australia
Secondary sponsor category [2] 285825 0
Individual
Name [2] 285825 0
Professor Andrew Mackinnon
Address [2] 285825 0
Orygen Research Centre
University of Melbourne
35 Poplar Road
Parkville VIC 3052
Country [2] 285825 0
Australia
Secondary sponsor category [3] 285826 0
Individual
Name [3] 285826 0
Dr Alison Calear
Address [3] 285826 0
Centre for Mental Health Research
63 Eggleston Road, Acton, Canberra ACT, 0200
Country [3] 285826 0
Australia
Secondary sponsor category [4] 285827 0
Individual
Name [4] 285827 0
Dr Phil Batterham
Address [4] 285827 0
Centre for Mental Health Research
63 Eggleston Road, Acton, Canberra ACT, 0200
Country [4] 285827 0
Australia
Secondary sponsor category [5] 285828 0
Individual
Name [5] 285828 0
Professor Ad Kerkhof
Address [5] 285828 0
Department of Clinical Psychology
VU University Amsterdam
van der Boechorststraat 1
1081 BT Amsterdam
Country [5] 285828 0
Netherlands
Secondary sponsor category [6] 285829 0
Individual
Name [6] 285829 0
Mr John Gosling
Address [6] 285829 0
Centre for Mental Health Research
63 Eggleston Road, Acton, Canberra ACT, 0200
Country [6] 285829 0
Australia
Secondary sponsor category [7] 286632 0
Individual
Name [7] 286632 0
Dr Daniela Solomon
Address [7] 286632 0
Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick, NSW, 2031
Country [7] 286632 0
Australia
Other collaborator category [1] 277351 0
Individual
Name [1] 277351 0
Dr Fiona Shand
Address [1] 277351 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country [1] 277351 0
Australia
Other collaborator category [2] 277352 0
Individual
Name [2] 277352 0
Mr Daniel Winter
Address [2] 277352 0
Global Media Empire Pty Ltd
PO Box 1555
Ashfield, NSW 1800
Country [2] 277352 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289080 0
University of New South Wales HREC
Ethics committee address [1] 289080 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 289080 0
Australia
Date submitted for ethics approval [1] 289080 0
19/04/2013
Approval date [1] 289080 0
10/07/2013
Ethics approval number [1] 289080 0
#HC13117
Ethics committee name [2] 289841 0
Australian National University HREC
Ethics committee address [2] 289841 0
Lower Ground Floor
Chancelry 10B
East Road
The Australian National University
Acton ACT 0200
Ethics committee country [2] 289841 0
Australia
Date submitted for ethics approval [2] 289841 0
Approval date [2] 289841 0
01/08/2013
Ethics approval number [2] 289841 0
2013/416

Summary
Brief summary
This project aims to test whether a web-based self-help program is effective in reducing suicidal thoughts when compared with an attention matched control condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39122 0
Prof Helen Christensen
Address 39122 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 39122 0
Australia
Phone 39122 0
+61 2 9382 9288
Fax 39122 0
Email 39122 0
[email protected]
Contact person for public queries
Name 39123 0
Bregje van Spijker
Address 39123 0
Centre for Mental Health Research
63 Eggleston Road, Acton, Canberra ACT, 0200
Country 39123 0
Australia
Phone 39123 0
+61 2 6128 0108
Fax 39123 0
Email 39123 0
[email protected]
Contact person for scientific queries
Name 39124 0
Bregje van Spijker
Address 39124 0
Centre for Mental Health Research
63 Eggleston Road, Acton, Canberra ACT, 0200
Country 39124 0
Australia
Phone 39124 0
+61 2 6128 0108
Fax 39124 0
Email 39124 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
SourceTitleYear of PublicationDOI
EmbaseReducing suicidal thoughts in the Australian general population through web-based self-help: Study protocol for a randomized controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0589-1
EmbaseEffectiveness of a Web-Based Self-Help Program for Suicidal Thinking in an Australian Community Sample: Randomized Controlled Trial.2018https://dx.doi.org/10.2196/jmir.8595
EmbaseConsistency of trajectories of suicidal ideation and depression symptoms: Evidence from a randomized controlled trial.2019https://dx.doi.org/10.1002/da.22863
N.B. These documents automatically identified may not have been verified by the study sponsor.