NCT02872610

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
439

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 11, 2019

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

August 9, 2016

Last Update Submit

July 10, 2019

Conditions

Suicidal Thoughts

Keywords

suicidal thoughtssuicidal ideationInternet interventionself-help

Outcome Measures

Primary Outcomes (1)

  • 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 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

    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)

    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

    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

    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

    At baseline and 2, 4, and 6 weeks after baseline

  • +26 more secondary outcomes

Other Outcomes (5)

  • Demographic questions measured with questions from the Trimbos and iMTA questionnaire for Costs associated with Psychiatric Illness

    At baseline

  • 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)

  • 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)

  • +2 more other outcomes

Study Arms (2)

Self-help Online

EXPERIMENTAL

6 weeks of internet-based self-help intervention

Behavioral: Self-help Online

Wait-list

NO INTERVENTION

Waiting list control condition

Interventions

Self-help OnlineBEHAVIORAL

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.

Self-help Online

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18 years old
  • Have a personal code card (NemID)
  • Sufficient command of the Danish language

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Centre Copenhagen

Hellerup, 2900, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 34464522DERIVED

  • Muhlmann 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.

    PMID: 28129783DERIVED

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Merete Nordentoft, Professor

    Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 19, 2016

Study Start

August 1, 2016

Primary Completion

September 2, 2018

Study Completion

July 1, 2019

Last Updated

July 11, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

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.

Locations

DK(1)