NCT04463654

Zero Self-Harm - a Mobile Phone Application to Reduce Non-suicidal Self-injury

Completed NA Last updated 21 November 2024

What this trial tests

NA trial testing Zero Self-Harm app in Self-Injurious Behavior in 280 participants. Completed in 24 October 2024.

Timeline

15 October 2020

Primary endpoint
24 April 2024

24 October 2024

Quick facts

Lead sponsor	Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	280
Start date	15 October 2020
Primary completion	24 April 2024
Estimated completion	24 October 2024
Sites	1 location across Denmark

Drugs / interventions tested

• Zero Self-Harm app

Conditions studied

• Self-Injurious Behavior — all drugs for Self-Injurious Behavior →

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Who can join

18 and older, any sex, with Self-Injurious Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Non-suicidal self-injury (NSSI), the deliberate, self-inflicted destruction of body tissue without suicidal intent and for purposes not socially sanctioned, is an increasing health care problem in Denmark. Approximately 20 % of Danish adolescents report a history of NSSI at some point in their lives. Individuals with NSSI have an increased risk of suicidality. Therefore, it is of great importance to develop and investigate the effectiveness of a low-cost app in reducing NSSI.

The purpose is to investigate whether treatment as usual (TAU) and the Zero Self-Harm app is superior to TAU in reducing 1) frequency of NSSI-episodes and 2) suicide ideation, and depressive symptoms in individuals with NSSI. As people with NSSI, without a comorbid psychiatric diagnosis, are not eligible to receive psychiatric treatment in Denmark, TAU includes many different treatments and counseling services, i.e. counseling at non-profit organizations, service centers in the municipalities, outpatient treatment services for psychiatric disorders, and care, information and attention at emergency departments. Common to them all is that they do not offer specialized treatment focused on NSSI.

The trial is designed as a 2-arm, parallel group, 6 months, randomized clinical superiority trial. A total of 280 participants, 140 in each arm, will be included. One group will receive TAU, the other will receive TAU and the Zero Self-Harm App. Participants will be recruited through non-profit organizations, service centers in the municipalities, outpatient treatment services, and psychiatric and somatic emergency departments in Denmark.

Inclusion criteria are engagement in two or more episodes of NSSI in the past month, no further planned treatment, have a smartphone, fluent in Danish, provide an informed written consent, age above 18 years.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Zero Self-Harm app: a mobile phone application to reduce non-suicidal self-injury-study protocol for a randomized controlled trial.
   Guerrero E, Andreasson K, Larsen L, Buus N, et al · · 2024 · PMID 38341590 · DOI 10.1186/s13063-024-07932-1
2. Zero Self-Harm app – a mobile phone application to reduce non-suicidal self-injury: Study protocol for a randomized controlled trial
   Andreasson K, Larsen L, Buus N, Larsen J, et al · · 2022 · DOI 10.21203/rs.3.rs-1755977/v1