Suicidal Thoughts Clinical Trial
Official title:
The Self-help Online Against Suicidal Thoughts (SOS) Trial - a Danish Randomized Wait-list Controlled Trial for People With Suicidal Thoughts
The objective of the SOS-trial is to examine if an online self-help intervention is effective in reducing suicidal thoughts among people at risk of suicide. The SOS-trial is a randomized, wait-list controlled trial with 1:1 allocation ratio. A total of 438 people with suicidal thoughts will be allocated to the intervention condition (N=219) or the control condition (N=219). The intervention condition consists of a six-week internet-based self-help therapy intervention. The control condition consists of a waiting list assignment for 32 weeks. The primary hypothesis is that the intervention is superior to the control condition in reducing suicidal thoughts at post-test (6 weeks). The SOS-trial is a partial replication of a previously conducted Dutch trial.
Suicide accounts for over 800,000 deaths each year and suicidal thoughts are common and cause
distress for millions of people over the world.
With this study, the investigators wish to examine the effectiveness of an online self-help
intervention in reducing suicidal thoughts among people at risk of suicide.
The participants will be recruited through the Danish online and telephone service, the
Lifeline's website. Persons who consent to participate in the study will be randomized to the
intervention or control condition using a centralized and computer-based algorithm that is
stratified by sex and level of suicidal ideation. The intervention consists of an online
self-help program with six modules that each takes a week to complete. Every module has a
theoretical section, a compulsory exercise, and several optional exercises. The participants
will be encouraged to spend a minimum of 30 minutes every day with the self-help program. The
participants in the control condition will have access to the website but not the
intervention modules.
Measurements with self-report questionnaires will be carried out at baseline and after 2, 4,
6, and 32 weeks. The participants in the control condition, will after 6 months on the
waiting list mode assessment have access to the intervention. These participants will further
be assessed 3 times, i.e. after 34, 36 and 38 weeks.
The null-hypothesis assumption of no difference between the intervention and control
condition with respect to suicidal thoughts and the secondary outcome measures will be
tested. Mixed models will be used to assess changes over time in suicidal thoughts and level
of depression, with the measurements at baseline, 2, 4, and 6 weeks (post-test) as well as
the long-term effect at 32 weeks (6 months after post-test). Changes in secondary outcomes
will, apart from the participant's depression level, be measured with ANCOVA using multiple
imputations. The investigators will use Cohen's d test to determine the difference between
the intervention and control condition.
If the true difference in the experimental and control mean is 0.3 in the Danish trial and a
pooled standard deviation at post-test at 1 is expected, then 350 participants in each
condition is needed in order to reject the null hypothesis that there is no difference
between the intervention and control condition at post-test on suicidal thoughts with
probability (power) 0.8. The type I error probability associated with this test of the null
hypothesis is 0.05. By accounting for a drop-out rate of 20%, a total of 438 participants
will be needed in the SOS-trial.
The participants constitute a vulnerable group, and a safety procedure has therefore been
developed. Participants will only be included if they provide their telephone number and the
number of a contact person upon enrollment. During the first 6 weeks of the trial, the Beck
Scale for Suicide Ideation will be administered biweekly; if a participant in either the
intervention or control condition scores ≥ 27 on the scale, he or she will receive a
telephone call from the trial manager. If the participant cannot be reached during three
attempts over three days, the participant's contact person will be contacted. The same
procedure will be used out if a participant ceases to follow the intervention without
notifying the trial manager.
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