Suicidal ThoughtsNCT02872610
The Self-help Online Against Suicidal Thoughts (SOS) Trial
A study testing Self-help Online in people with Suicidal Thoughts, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Thoughts
- What is being tested?
- Self-help Online
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 439 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years old
- Have a personal code card (NemID)
- Sufficient command of the Danish language
Who cannot join
- No suicidal thoughts (defined as a score below 3 on the Beck Scale for Suicide Ideation).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Suicidal Thoughts
- Being tested
- Self-help Online
- Keywords
- suicidal thoughts, suicidal ideation, Internet intervention, self-help
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help OnlineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-help Online | Experimental | 6 weeks of internet-based self-help intervention Receives: Behavioral: Self-help Online |
| Wait-list | No intervention | Waiting list control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, and 2, 4, and 6 weeks after baseline
Secondary outcomes (31)
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).
Measured: At baseline, and 6 and 32 weeks after baseline
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.
Measured: At 32, 34, 36, and 38 weeks after baseline
Changes in suicidal thoughts from baseline to post-test (6 weeks) measured with the Suicidal Ideation Attributes Scale
Measured: At baseline and 6 weeks after baseline
Changes in suicidal thoughts from post-test (6 weeks) to follow-up (32 weeks) measured with the Suicidal Ideation Attributes Scale
Measured: 6 and 32 weeks after baseline
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.
Measured: At baseline and 2, 4, 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
Measured: 6 and 32 weeks after baseline
Changes in hopelessness from baseline to post-test (6 weeks) measured with the Beck Hopelessness Scale
Measured: 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
Measured: 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
Measured: At baseline and 6 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
Measured: 6 and 32 weeks after baseline
Changes in quality of life from baseline to post-test (6 weeks) measured with the WHO-Five Well-being Index
Measured: 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
Measured: 6 and 32 weeks after baseline
Episodes of deliberate self-harm the last six weeks measured with data from the Danish National Patient Register.
Measured: 6 weeks after baseline
Episodes of deliberate self-harm the last six months measured with data from the Danish National Patient Register
Measured: 32 weeks after baseline
Episodes of deliberate self-harm the last six weeks measured with data from the Danish National Patient Register
Measured: 38 weeks after baseline (only participants in the control condition)
Episodes of deliberate self-harm the last six weeks measured a self-report questionnaire
Measured: 6 weeks after baseline
Episodes of deliberate self-harm the last six months measured a self-report questionnaire
Measured: 32 weeks after baseline
Episodes of deliberate self-harm the last six weeks measured a self-report questionnaire
Measured: 38 weeks after baseline (only participants in the control condition)
Death by suicide measured with the data extract from the Danish Cause of Death Register; (ICD-10: X60-X84)
Measured: 6 weeks after baseline
Death by suicide measured with the data extract from the Danish Cause of Death Register; (ICD-10: X60-X84)
Measured: 32 weeks after baseline
Death by suicide measured with the data extract from the Danish Cause of Death Register; (ICD-10: X60-X84)
Measured: 38 weeks after baseline (only participants in the control condition)
Health care utilization from baseline to post-test (6 weeks) measured with The National Patient Register
Measured: 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
Measured: 6 and 32 weeks after baseline
Health care utilization from baseline to post-test (6 weeks) measured with National Health Service Register
Measured: 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
Measured: 6 and 32 weeks after baseline
Health care utilization from baseline to post-test (6 weeks) measured with the National Prescription Registry
Measured: At baseline and 6 weeks after baseline
Health care utilization from post-test (6 weeks) to follow-up (32 weeks) measured with the National Prescription Registry
Measured: 6 and 32 weeks after baseline
Health care utilization from baseline to post-test (6 weeks) measured with the Psychiatric Central Research Register
Measured: At baseline and 6 weeks after baseline
Health care utilization from post-test (6 weeks) to follow-up (32 weeks) measured with the Psychiatric Central Research Register
Measured: 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
Measured: At baseline and 6 weeks after baseline
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
Measured: 6 and 32 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion2 Sep 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicidal ThoughtsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Merete Nordentoft, Professor, Principal investigator, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872610
- Sponsor's protocol ID
- SOS-trial
- Other IDs
- 106690
- Status last verified
- May 2019
- First submitted
- 9 Aug 2016
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A de-identified dataset generated during the study and the statistical code used for the analysis will be available upon request, once the data has been collected and analyzed by the research group.
Publications
Muhlmann C, Madsen T, Hjorthoj C, Forman JL, Kerkhof AJFM, Nordentoft M, Erlangsen A. Effectiveness of an Internet-Based Self-help Therapy Program for Suicidal Ideation With Follow-up at 6 Months: Results of a Randomized Controlled Trial. J Clin Psychiatry. 2021 Aug 31;82(5):20m13803. doi: 10.4088/JCP.20m13803.
PubMed 34464522Muhlmann C, Madsen T, Hjorthoj C, Kerkhof A, Nordentoft M, Erlangsen A. The Self-help Online against Suicidal thoughts (SOS) trial: study protocol for a randomized controlled trial. Trials. 2017 Jan 28;18(1):45. doi: 10.1186/s13063-017-1794-x.
PubMed 28129783
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Self-help Online Against Suicidal Thoughts (SOS) Trial - a Danish Randomized Wait-list Controlled Trial for People With Suicidal Thoughts
- ClinicalTrials.gov ID
- NCT02872610
- Acronym / sponsor ID
- SOS-trial
- Conditions
- Suicidal Thoughts
- Keywords
- suicidal thoughts, suicidal ideation, Internet intervention, self-help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Aug 2016
- Primary completion
- 2 Sep 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-help Online | Experimental | Behavioral: Self-help Online6 weeks of internet-based self-help intervention |
| Wait-list | No intervention | –Waiting list control condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18 years old
- Have a personal code card (NemID)
- Sufficient command of the Danish language
Key exclusion criteria (1 listed)
- No suicidal thoughts (defined as a score below 3 on the Beck Scale for Suicide Ideation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-help OnlineThe 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. | Behavioural | Self-help Online |
Primary outcome
Changes in suicidal thoughts from baseline to 2, 4, and 6 weeks measured with the Beck Scale for Suicide Ideation
Time frame: 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.
31 secondary outcomes
Changes in suicidal thoughts from baseline to post-test (6 weeks) and follow-up (32 weeks) measured with the Beck Scale for Suicide Ideation
Time frame: At baseline, and 6 and 32 weeks after baseline
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)
Time frame: At 32, 34, 36, and 38 weeks after baseline
Changes in suicidal thoughts from baseline to post-test (6 weeks) measured with the Suicidal Ideation Attributes Scale
Time frame: At baseline and 6 weeks after baseline
Changes in suicidal thoughts from post-test (6 weeks) to follow-up (32 weeks) measured with the Suicidal Ideation Attributes Scale
Time frame: 6 and 32 weeks after baseline
Changes in depression level from baseline to 2, 4, and 6 weeks measured with the Six-item Hamilton Depression Scale
Time frame: At baseline and 2, 4, 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
Time frame: 6 and 32 weeks after baseline
Changes in hopelessness from baseline to post-test (6 weeks) measured with the Beck Hopelessness Scale
Time frame: 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
Time frame: 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
Time frame: At baseline and 6 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
Time frame: 6 and 32 weeks after baseline
Changes in quality of life from baseline to post-test (6 weeks) measured with the WHO-Five Well-being Index
Time frame: 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
Time frame: 6 and 32 weeks after baseline
Episodes of deliberate self-harm the last six weeks measured with data from the Danish National Patient Register.
Time frame: 6 weeks after baseline
Episodes of deliberate self-harm the last six months measured with data from the Danish National Patient Register
Time frame: 32 weeks after baseline
Episodes of deliberate self-harm the last six weeks measured with data from the Danish National Patient Register
Time frame: 38 weeks after baseline (only participants in the control condition)
Episodes of deliberate self-harm the last six weeks measured a self-report questionnaire
Time frame: 6 weeks after baseline
Episodes of deliberate self-harm the last six months measured a self-report questionnaire
Time frame: 32 weeks after baseline
Episodes of deliberate self-harm the last six weeks measured a self-report questionnaire
Time frame: 38 weeks after baseline (only participants in the control condition)
Death by suicide measured with the data extract from the Danish Cause of Death Register; (ICD-10: X60-X84)
Time frame: 6 weeks after baseline
Death by suicide measured with the data extract from the Danish Cause of Death Register; (ICD-10: X60-X84)
Time frame: 32 weeks after baseline
Death by suicide measured with the data extract from the Danish Cause of Death Register; (ICD-10: X60-X84)
Time frame: 38 weeks after baseline (only participants in the control condition)
Health care utilization from baseline to post-test (6 weeks) measured with The National Patient Register
Time frame: 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
Time frame: 6 and 32 weeks after baseline
Health care utilization from baseline to post-test (6 weeks) measured with National Health Service Register
Time frame: 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
Time frame: 6 and 32 weeks after baseline
Health care utilization from baseline to post-test (6 weeks) measured with the National Prescription Registry
Time frame: At baseline and 6 weeks after baseline
Health care utilization from post-test (6 weeks) to follow-up (32 weeks) measured with the National Prescription Registry
Time frame: 6 and 32 weeks after baseline
Health care utilization from baseline to post-test (6 weeks) measured with the Psychiatric Central Research Register
Time frame: At baseline and 6 weeks after baseline
Health care utilization from post-test (6 weeks) to follow-up (32 weeks) measured with the Psychiatric Central Research Register
Time frame: 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
Time frame: At baseline and 6 weeks after baseline
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
Time frame: 6 and 32 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Derived from this study: PubMed 34464522Muhlmann C, Madsen T, Hjorthoj C, Forman JL, Kerkhof AJFM, Nordentoft M, Erlangsen A. Effectiveness of an Internet-Based Self-help Therapy Program for Suicidal Ideation With Follow-up at 6 Months: Results of a Randomized Controlled Trial. J Clin Psychiatry. 2021 Aug 31;82(5):20m13803. doi: 10.4088/JCP.20m13803.
- Derived from this study: PubMed 28129783Muhlmann C, Madsen T, Hjorthoj C, Kerkhof A, Nordentoft M, Erlangsen A. The Self-help Online against Suicidal thoughts (SOS) trial: study protocol for a randomized controlled trial. Trials. 2017 Jan 28;18(1):45. doi: 10.1186/s13063-017-1794-x.
- Individual participant dataSharing planned: Yes. A de-identified dataset generated during the study and the statistical code used for the analysis will be available upon request, once the data has been collected and analyzed by the research group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Nordentoft, Professor principal investigator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help Online in people with Suicidal Thoughts, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in suicidal thoughts from baseline to 2, 4, and 6 weeks measured with the Beck Scale for Suicide Ideation (time frame: At baseline, and 2, 4, and 6 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02872610, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.