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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02872610
Date of registration:	09/08/2016
Prospective Registration:	No
Primary sponsor:	Mental Health Services in the Capital Region, Denmark
Public title:	The Self-help Online Against Suicidal Thoughts (SOS) Trial
Scientific title:	The Self-help Online Against Suicidal Thoughts (SOS) Trial - a Danish Randomized Wait-list Controlled Trial for People With Suicidal Thoughts
Date of first enrolment:	August 2016
Target sample size:	439
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02872610
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Denmark

Contacts

Name:	Merete Nordentoft, Professor
Address:
Telephone:
Email:
Affiliation:	Mental Health Centre Copenhagen

Key inclusion & exclusion criteria

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).

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Suicidal Thoughts

Intervention(s)

Behavioral: Self-help Online

Primary Outcome(s)

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]

Secondary Outcome(s)

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 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]

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]

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)]

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]

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]

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]

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]

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)]

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]

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 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]

Episodes of deliberate self-harm the last six months measured a self-report questionnaire [Time Frame: 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]

Episodes of deliberate self-harm the last six weeks measured a self-report questionnaire [Time Frame: 6 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]

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 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]

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]

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]

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]

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]

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 National Health Service Register [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: 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]

Secondary ID(s)

SOS-trial

106690

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Aarhus

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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