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 |