The Self-help Online Against Suicidal Thoughts (SOS) Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872610
• Other study ID #: SOS-trial
• Secondary ID: 106690
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: May 2019
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: July 1, 2019
• Est. primary completion date: September 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18 years old

• Have a personal code card (NemID)

• Sufficient command of the Danish language

Exclusion Criteria:

• No suicidal thoughts (defined as a score below 3 on the Beck Scale for Suicide Ideation).

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicidal Thoughts

Intervention

Behavioral:
• Self-help Online
The internet-based self-help program consist of 6 modules that each take a week to complete. Every module consists of a theoretical section, a compulsory exercise, and several optional exercises: Participants are encouraged to spend a minimum of 30 minutes every day with the self-help program. On the website, the participants in the intervention condition may also access an "Acute Help" page where information on help options are listed and a "My Profile" page where changes to login and contact details may be made, also, the informed consent form is found here. Participants may furthermore access a message system where they can write questions to the trial manager.

Locations

Country	Name	City	State
Denmark	Mental Health Centre Copenhagen	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic questions measured with questions from the Trimbos and iMTA questionnaire for Costs associated with Psychiatric Illness		At baseline
Other	Negative effects of the intervention assessed with self-report questions made by the research team		6 weeks after baseline (only participants in the intervention condition)
Other	Negative effects of the intervention assessed with self-report questions made by the research team		38 weeks after baseline (only participants in the control condition)
Other	Evaluation and utility of the intervention measured with the Internet Evaluation and Utility Questionnaire		6 weeks after baseline (only participants in the intervention condition)
Other	Evaluation and utility of the intervention measured with the Internet Evaluation and Utility Questionnaire		38 weeks after baseline (only participants in the control condition)
Primary	Changes in suicidal thoughts from baseline to 2, 4, and 6 weeks measured with the Beck Scale for Suicide Ideation	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.	At baseline, and 2, 4, and 6 weeks after baseline
Secondary	Changes in suicidal thoughts from baseline to post-test (6 weeks) and follow-up (32 weeks) measured with the Beck Scale for Suicide Ideation	Mixed models will be used to assess the long-term effect with measurements at baseline, 6 weeks (post-test), and 32 weeks (6 months after post-test).	At baseline, and 6 and 32 weeks after baseline
Secondary	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)	Mixed models will use measurements at follow-up (32 weeks), 34, 36, and 38 weeks with the purpose of modeling changes over time in suicidal thoughts for those participants in the control condition who decides to start the self-help intervention.	At 32, 34, 36, and 38 weeks after baseline
Secondary	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
Secondary	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
Secondary	Changes in depression level from baseline to 2, 4, and 6 weeks measured with the Six-item Hamilton Depression Scale	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 depression level.	At baseline and 2, 4, and 6 weeks after baseline
Secondary	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
Secondary	Changes in hopelessness from baseline to post-test (6 weeks) measured with the Beck Hopelessness Scale		At baseline and 6 weeks after baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Episodes of deliberate self-harm the last six weeks measured with data from the Danish National Patient Register.		6 weeks after baseline
Secondary	Episodes of deliberate self-harm the last six months measured with data from the Danish National Patient Register		32 weeks after baseline
Secondary	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)
Secondary	Episodes of deliberate self-harm the last six weeks measured a self-report questionnaire		6 weeks after baseline
Secondary	Episodes of deliberate self-harm the last six months measured a self-report questionnaire		32 weeks after baseline
Secondary	Episodes of deliberate self-harm the last six weeks measured a self-report questionnaire		38 weeks after baseline (only participants in the control condition)
Secondary	Death by suicide measured with the data extract from the Danish Cause of Death Register; (ICD-10: X60-X84)		6 weeks after baseline
Secondary	Death by suicide measured with the data extract from the Danish Cause of Death Register; (ICD-10: X60-X84)		32 weeks after baseline
Secondary	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)
Secondary	Health care utilization from baseline to post-test (6 weeks) measured with The National Patient Register		At baseline and 6 weeks after baseline
Secondary	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
Secondary	Health care utilization from baseline to post-test (6 weeks) measured with National Health Service Register		At baseline and 6 weeks after baseline
Secondary	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
Secondary	Health care utilization from baseline to post-test (6 weeks) measured with the National Prescription Registry		At baseline and 6 weeks after baseline
Secondary	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
Secondary	Health care utilization from baseline to post-test (6 weeks) measured with the Psychiatric Central Research Register		At baseline and 6 weeks after baseline
Secondary	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
Secondary	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
Secondary	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