The Self-help Online Against Suicidal Thoughts (SOS) Trial - a Danish Randomized Wait-list Controlled Trial for People With Suicidal Thoughts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 439
- 试验地点
- 2
- 主要终点
- Changes in suicidal thoughts from baseline to 2, 4, and 6 weeks measured with the Beck Scale for Suicide Ideation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years old
- •Have a personal code card (NemID)
- •Sufficient command of the Danish language
排除标准
- •No suicidal thoughts (defined as a score below 3 on the Beck Scale for Suicide Ideation).
研究组 & 干预措施
Self-help Online
6 weeks of internet-based self-help intervention
干预措施: Self-help Online (Behavioral)
Wait-list
Waiting list control condition
结局指标
主要结局
Changes in suicidal thoughts from baseline to 2, 4, and 6 weeks measured with the Beck Scale for Suicide Ideation
时间窗: At baseline, and 2, 4, and 6 weeks after baseline
Linear mixed models with repeated measurements and an unstructured covariance matrix, will use measurements at baseline, 2, 4, and 6 weeks (post-test) with the purpose of modeling changes over time in suicidal thoughts.
次要结局
- Changes in suicidal thoughts from follow-up (32 weeks) to 34, 36, and 38 weeks in suicidal thoughts measured with the Beck Scale for Suicide Ideation (only for participants in the control condition who decides to start the self-help intervention)(At 32, 34, 36, and 38 weeks after baseline)
- Changes in suicidal thoughts from post-test (6 weeks) to follow-up (32 weeks) measured with the Suicidal Ideation Attributes Scale(6 and 32 weeks after baseline)
- Changes in worrying from post-test (6 weeks) to follow-up (32 weeks) measured with the Penn State Worry Questionnaire Past Week(6 and 32 weeks after baseline)
- Death by suicide measured with the data extract from the Danish Cause of Death Register; (ICD-10: X60-X84)(38 weeks after baseline (only participants in the control condition))
- Health care utilization from baseline to post-test (6 weeks) measured with the Psychiatric Central Research Register(At baseline and 6 weeks after baseline)
- Changes in depression level from post-test (6 weeks) to follow-up (32 weeks) measured with the Six-item Hamilton Depression Scale(6 and 32 weeks after baseline)
- Changes in suicidal thoughts from baseline to post-test (6 weeks) and follow-up (32 weeks) measured with the Beck Scale for Suicide Ideation(At baseline, and 6 and 32 weeks after baseline)
- Changes in suicidal thoughts from baseline to post-test (6 weeks) measured with the Suicidal Ideation Attributes Scale(At baseline and 6 weeks after baseline)
- Changes in hopelessness from baseline to post-test (6 weeks) measured with the Beck Hopelessness Scale(At baseline and 6 weeks after baseline)
- Changes in hopelessness from post-test (6 weeks) to follow-up (32 weeks) measured with the Beck Hopelessness Scale(6 and 32 weeks after baseline)
- Changes in worrying from baseline to post-test (6 weeks) measured with the Penn State Worry Questionnaire Past Week(At baseline and 6 weeks after baseline)
- Changes in quality of life from post-test (6 weeks) to follow-up (32 weeks) measured with the WHO-Five Well-being Index(6 and 32 weeks after baseline)
- Episodes of deliberate self-harm the last six weeks measured with data from the Danish National Patient Register.(6 weeks after baseline)
- Episodes of deliberate self-harm the last six weeks measured a self-report questionnaire(38 weeks after baseline (only participants in the control condition))
- Episodes of deliberate self-harm the last six months measured a self-report questionnaire(32 weeks after baseline)
- Health care utilization from baseline to post-test (6 weeks) measured with The National Patient Register(At baseline and 6 weeks after baseline)
- Health care utilization from post-test (6 weeks) to follow-up (32 weeks) measured with National Health Service Register(6 and 32 weeks after baseline)
- Health care utilization from post-test (6 weeks) to follow-up (32 weeks) measured with the National Prescription Registry(6 and 32 weeks after baseline)
- Health care utilization from post-test (6 weeks) to follow-up (32 weeks) measured with the Psychiatric Central Research Register(6 and 32 weeks after baseline)
- Production loss from baseline to post-test (6 weeks) measured with the Trimbos and iMTA questionnaire for Costs associated with Psychiatric Illness(At baseline and 6 weeks after baseline)
- Changes in depression level from baseline to 2, 4, and 6 weeks measured with the Six-item Hamilton Depression Scale(At baseline and 2, 4, and 6 weeks after baseline)
- Changes in quality of life from baseline to post-test (6 weeks) measured with the WHO-Five Well-being Index(At baseline and 6 weeks after baseline)
- Health care utilization from post-test (6 weeks) to follow-up (32 weeks) measured with The National Patient Register(6 and 32 weeks after baseline)
- Health care utilization from baseline to post-test (6 weeks) measured with National Health Service Register(At baseline and 6 weeks after baseline)
- Health care utilization from baseline to post-test (6 weeks) measured with the National Prescription Registry(At baseline and 6 weeks after baseline)
- Episodes of deliberate self-harm the last six months measured with data from the Danish National Patient Register(32 weeks after baseline)
- Episodes of deliberate self-harm the last six weeks measured with data from the Danish National Patient Register(38 weeks after baseline (only participants in the control condition))
- Production loss from post-test (6 weeks) to follow-up (32 weeks) measured with the Trimbos and iMTA questionnaire for Costs associated with Psychiatric Illness(6 and 32 weeks after baseline)