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Table 1 World Health Organization Trial Registration Data Set

From: The Self-help Online against Suicidal thoughts (SOS) trial: study protocol for a randomized controlled trial

Data category

Information

Primary registry and trial identifying number

ClinicalTrials.gov NCT02872610.

Date of registration in primary registry

18 August 2016

Secondary identifying number

TrygFonden 106690

The Research Ethics Committee of the Capital Region of Denmark H-15002490

Source(s) of monetary or material support

TrygFonden reference number 106690

Primary sponsor

Merete Nordentoft, Mental Health Centre Copenhagen

Contact for public queries

CM: Charlotte.Muehlmann@regionh.dk

MN: Merete.nordnetoft@regionh.dk

AE: Annette.erlangsen@regionh.dk

Contact for scientific queries

CM, MN, AE Charlotte.Muehlmann@regionh.dk

Merete.nordnetoft@regionh.dk

Annette.erlangsen@regionh.dk

Mental Health Centre Copenhagen

Public title

The Self-help Online against Suicidal thoughts (SOS) trial – a Danish randomized controlled waiting-list trial for people with suicidal thoughts

Scientific title

The Self-help Online against Suicidal thoughts (SOS) trial – a Danish randomized controlled waiting-list trial for people with suicidal thoughts

Countries of recruitment

Denmark

Health condition(s) or problem(s) studied

Suicidal thoughts

Intevention(s)

An Internet-based self-help intervention for people with suicidal thoughts

Waiting-list control condition

Key inclusion and exclusion criteria

Ages eligible for study: ≥18 years; sexes eligible for study: both

Inclusion criteria: 18 years or older; sufficient command of the Danish language; have a personal code card (NemID)

Exclusion criteria: no suicidal thoughts (defined as a cutoff score of <3 on the Beck Scale for Suicide Ideation)

Study type

Interventional

Allocation: randomized

Intervention model: parallel assignment

Primary purpose: to lower the participant’s degree of suicidal thoughts

Date of first enrolment

August 2016

Target sample size

438

Recruitment status

Pending

Primary outcome(s)

Outcome: suicidal thoughts

Method of measurement: Beck Scale for Suicide Ideation

Time point: 2, 4 and 6 weeks after baseline, with time × group interaction test as indicator of efficacy

Key secondary outcomes

Suicidal thoughts, depression, hopelessness, worrying, quality of life, health care utilization, medication prescriptions, production loss, episodes of deliberate self-harm, death by suicide, negative effects of the intervention and evaluation and utility of the self-help program