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

NCT04463654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-11-21

No results posted yet for this study

Summary

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.

Conditions

  • Self-Injurious Behavior

Interventions

DEVICE

Zero Self-Harm app

Safety plan app for smartphones

Sponsors & Collaborators

  • TrygFonden, Denmark

    collaborator INDUSTRY

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Merete Nordentoft, MD, Ph.D MSc · Mental Health Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2024-04-24
Completion
2024-10-24

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04463654 on ClinicalTrials.gov