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

NCT04463654 | Completed DMC

• 1 other identifier: 213+983
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Deliberate Self Harm Inventory

  17-item self-report questionnaire that assesses various aspects of self harm (defined as the deliberate, direct self-destruction of body tissue without suicidal intent) over specified time periods, including frequency (continuous range) and type of self-harm behavior (e.g. cutting, burning etc.). The DSHI demonstrates adequate test-retest reliability and construct, discriminant validity among non-clinical and patient samples

  6 month

Other Outcomes (4)

• Becks Suicide Ideation Scale

  6 month

• Major Depression Inventory (MDI)

  6 month

• WHO Well-being Index

  6 month

Study Arms (2)

Zero Self-Harm

EXPERIMENTAL

When randomized to the Zero Self-Harm app the participants will receive an introduction to the app through videos in the app, which explains, amongst others, how to review previous crisis situations and possible strategies for future crisis. This will ensure the navigation and knowledge of the technicalities of the app, in addition to ensure the app can be used privately without personal guidance from e.g a therapist.

Device: Zero Self-Harm app

Treatment as usual

NO INTERVENTION

The control group will continue their present course of treatment and/or counseling at non-profit organizations, service centers in the municipalities, at outpatient treatment services for psychiatric disorders and/or care, attention at emergency departments. They will receive no treatment on the nature of NSSI. Participants in the control group will be offered a possibility to download the Zero Self-Harm app after they have completed the last questionnaire at six months, which will be stressed at the initial appointment as well as after collection of all data.

Interventions

Zero Self-Harm app DEVICE

Safety plan app for smartphones

Zero Self-Harm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Engagement in two or more episodes of NSSI in the past month.
• No further planned treatment focused on NSSI.
• Have a smartphone (IPhone or Android phone).
• Fluent in Danish.
• Skills sufficient to enable use of the Zero Self-Harm app.
• Provide an informed written consent.
• Age ≥ 18 years.

You may not qualify if:

• Lack of informed consent.
• Forced care.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• TrygFonden, Denmark: collaborator

Study Sites (1)

Kate Trein Andreasson Aamund

Hillerød, 3400, Denmark

Location

Related Publications (1)

• Guerrero E, Andreasson K, Larsen L, Buus N, Skovgaard Larsen JL, Krogh J, Thastum R, Lindberg L, Lindblad K, Erlangsen A, Nordentoft M. Zero Self-Harm app: a mobile phone application to reduce non-suicidal self-injury-study protocol for a randomized controlled trial. Trials. 2024 Feb 10;25(1):116. doi: 10.1186/s13063-024-07932-1.

  PMID: 38341590 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Merete Nordentoft, MD, Ph.D MSc

  Mental Health Center Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 9, 2020
• Study Start: October 15, 2020
• Primary Completion: April 24, 2024
• Study Completion: October 24, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)