Reducing suicidal thoughts in the Australian general population through web-based self-help: study protocol for a randomized controlled trial

This study is designed as a two-arm randomized controlled trial with one active program (‘Living with Deadly Thoughts’) and one control program (‘Living Well’). There will be five main measurement occasions: screening, baseline, post-test (6 weeks after baseline), and two follow-up measures (6 and 12 months after post-test). In addition, suicidal thoughts will be monitored on a fortnightly basis during the first six weeks after randomization (that is, while the active group goes through the active program) to inform safety procedures (see below). The trial flow is illustrated in Figure 1. Participants who stop using the program they are assigned to will still be sent all follow-up questionnaires to complete (unless they have requested to be withdrawn from the study).

We adhere to the SPIRIT guidelines in reporting the trial in this protocol (see Table 1 for the items from the World Health Organization Trial Registration Data Set) [21,22].

A total of 570 Australian community dwelling adults experiencing suicidal thoughts will be recruited through various online and offline media, relevant websites, popular social networking sites and advertising on popular search engines. Through these advertisements, respondents are linked to a welcome screen where a brief introduction to the study is provided. Next, respondents will be invited to provide informed consent to complete the online screening procedure to verify eligibility.

Eligibility is based on 1) being aged between 18 and 65, 2) having a valid email address, 3) having a reliable internet connection, 4) currently being located in Australia, 5) being fluent in English, 6) never having been diagnosed with a psychotic disorder such as schizophrenia, 7) currently experiencing suicidal thoughts, and 8) not having attempted suicide in the past month.

During screening, respondents indicate their eligibility by answering questions about the above criteria. Ineligibility during the screening process results in redirection to a ‘thank you’ page with relevant referral information. Respondents who are excluded based on a recent suicide attempt (past month) are also provided with the opportunity to submit their phone number to receive a phone call from the Suicide Call Back Service (SCBS: a 24-hour, Australia-wide, not-for-profit service that provides telephone counseling to people who are suicidal).

All eligible respondents are provided with a participant information statement, which outlines that participation includes agreeing to make contact with the SCBS and completing the baseline questionnaire before being randomly allocated to one of the two programs. Making initial contact with the SCBS is needed as this organization plays a significant role in the safety procedures (described in more detail below). After having read the participant information statement (see Additional file 1), respondents will be invited to provide informed consent online (see Additional file 2) and will need to provide only a valid email address and a first name to register their participation. They are also given the option to submit their phone number while consenting, which can then be used in the safety procedures if needed, but this is not mandatory for participation. This way, participants can remain anonymous if desired. See also Figure 1 for the trial flow-chart. Participants only enter the trial after they have provided informed consent.

Randomization to the active program or the comparator will be on a 1:1 ratio and based on blocks of length 4, stratified by sex and severity/extent of suicidal thoughts. The latter is defined as endorsing ‘yes’ on item 5 of the ‘Suicidal Ideation’ part of the Columbia-Suicide Severity Rating Scale (C-SSRS) [23], regarding active suicidal ideation with specific plan and intent. The randomization procedure is incorporated into the website and therefore fully automated. Participants are blinded as to which program is active and which is control. Participants in the control condition will receive access to the LWDT program after the 12-month follow-up assessment.

The attention-matched control condition uses a 6-week program that contains lifestyle information. This program follows a similar structure to the active program; that is, each module contains theory, a weekly assignment, several exercises, and a number of FAQs. Each module has a different topic: 1) nutrition, 2) a healthy home environment, 3) a healthy weight, 4) a healthy heart, 5) a healthy skin, and 6) a healthy mouth. The program was designed so that no specific mental health information or suicide-related content was included. New modules become available 4 days after starting the previous module. Similar to the active program, participants in the Living Well program have access to referral information via a ‘get-help-now’ button that is visible from every page and are informed that participation is not meant to replace treatment they may already be receiving or the necessity to seek further treatment.

As this research is being conducted in a vulnerable, at-risk population, safety procedures were designed in collaboration with the Suicide Call Back Service (SCBS), which is an Australia-wide 24-hour service that provides telephone and online counseling to people 15 years and over who are suicidal, are bereaved by suicide, have a suicidal loved one, or are professionals working with suicidal clients. The goal was to design a procedure that would protect and assist participants while enabling them to maintain anonymity within the trial if they chose.

To be able to enroll in the study, eligible participants will be required to contact the SCBS to obtain a unique code. They will be required to submit this code on their first login to the trial portal, before the participant is directed to the baseline questionnaire. This code subsequently enables researchers to identify the participant to the SCBS when needed (and vice versa), while not revealing the identity of the individual.

On each measurement occasion (that is, 2 and 4 weeks into the program, the week 6 post-test, 6-month follow-up and 12-month follow-up), the first three items of the ‘intensity of ideation’ section of the C-SSRS are used to detect high risk, defined as a score of 5 on any of these items. Whenever a participant meets this criterion, an automated email will prompt them to contact the SCBS. If they do not contact the SCBS within 2 days, an automated reminder will be sent. At the same time of this reminder, an automated email will be sent to the SCBS, which will contain the participant’s contact details if these were provided at registration. If no contact details were provided, the SCBS will take no further action; otherwise the SCBS will try to call the participant with a maximum of three attempts.

These safety procedures were designed from the perspective that participants should be able to maintain their anonymity as much as possible considering ethical and clinical obligations and also should be allowed to remain autonomous in their decision to make contact with services as much as possible. This approach is consistent with the concept of self-help and patient empowerment.

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 [18], 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 ± 0.20 for the confidence intervals of the effect size, 285 starters (expected to yield 200 completers) would be needed in each condition (with alpha = 0.05 and power of 0.80). The aim is therefore to recruit 570 participants in the trial.

Primary analyses will be undertaken on an intention-to-treat basis, including all participants randomized regardless of their level of adherence to the program or trial drop-out (unless someone specifically requests to remove their data from the study). Available information from all participants will be retained using linear mixed models analyses. Transformation of variables will be done as necessary to meet distributional assumptions and to accommodate potential outlying observations. For other analyses, multiple imputation including demographic and other background variables will be used as necessary to allow inclusion of data from all participants.

A Data Safety Monitoring Board (DSMB) has been established for this study, consisting of two senior psychiatrists and one senior suicidologist. All members have extensive clinical and/or research experience with suicidal people. This DSMB is independent of all investigators and the funding agency, and no member of the DSMB has direct involvement in the conduct of the study. The DSMB will receive monthly reports from the trial manager detailing the number of participants contacting the SCBS and number of self-reported suicide attempts on completed follow-up questionnaires. Furthermore, the DSMB will be notified of any adverse events within 72 hours of knowledge of the event. The DSMB will also receive a report if there is any evidence suggesting potential risk to participants, for example, as detected by the trial manager or chief investigators. Finally, interim analyses will be performed once one-third of the total sample (that is, 190 participants) has reached 1) the 6-week post-test assessment, 2) the 6-month follow-up, and 3) the 12-month follow-up. The DSMB may recommend termination or modification of the study on the basis of any perceived safety concern based on their clinical judgment. This may include, but is not limited to, higher anticipated rates of primary safety indicators (suicidal ideation and attempted suicide, both assessed by self-report), or unexpected serious adverse events.

This study (protocol version 2, 17 June 2013) has been approved by the Human Research Ethics Committees of the University of New South Wales (#HC13117) and the Australian National University (2013/416). Any modifications to the protocol will be agreed upon by the researchers and approved by the ethics committees prior to implementation. Participant responses will be identified by a unique user ID. Data files linking email addresses to ID numbers will be stored separately from raw research data. Collected data will be stored on a secure server. All chief investigators will be given access to the data set, and data will be published in nonidentifiable form. Authorship will be based on contribution to the study. A de-identified data set will be available from the authors no later than 3 years after collection of the final post-test data.