80 Participants NeededMy employer runs this trial

Digital Intervention for Self-Harm

KK
Overseen ByKaylee Kruzan, PhD, LCSW
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to help teens who engage in nonsuicidal self-injury (NSSI). The goal is to determine if the app is user-friendly and effective in helping teens manage their emotions. Participants are divided into two groups: one uses the app with self-help tools, while the other receives healthy living tips. Teens who have engaged in self-injury at least twice in the past month and are not currently in therapy may be suitable candidates. Participants must speak English and own a smartphone. As an unphased trial, this study provides a unique opportunity for teens to contribute to innovative research that could enhance emotional well-being.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that app-based digital tools for managing nonsuicidal self-injury (NSSI) are generally safe and easy to use. Some studies have found these apps can offer support and be helpful for young people dealing with NSSI. For instance, a review of mobile apps designed to prevent suicide and self-harm found them promising for teenagers and young adults. These apps can help connect users to additional help and resources.

One study examined specific apps like Kalmer and found they can complement current treatments for NSSI. While researchers continue to study these digital tools, early results suggest they are safe to use. However, they should accompany traditional support, not replace it.12345

Why are researchers excited about this trial?

Researchers are excited about the app-based digital mental health intervention for adolescent non-suicidal self-injury (NSSI) because it offers a new, tech-driven approach to mental health care. Unlike traditional treatments that often involve in-person therapy sessions, this intervention is self-guided and accessible via an app, making it more flexible and potentially reaching adolescents who might not seek conventional help. Additionally, by offering psychoeducational materials through a digital platform, it empowers users with knowledge and tools to manage their own mental health actively. This novel delivery method could revolutionize how support is provided, making it more accessible and less stigmatizing for young people.

What evidence suggests that this trial's digital interventions could be effective for adolescent NSSI?

Research has shown that digital tools can help address self-harm behaviors in teenagers. This trial will compare two approaches: a self-guided digital intervention specifically designed for non-suicidal self-injury (NSSI) and a self-guided delivery of healthy living psychoeducational materials. Studies have found that app-based programs can improve mental health issues like depression and anxiety, which often accompany self-harm. For example, a mobile app for young people showed promise in helping with self-harm by providing support and encouraging them to seek help. Additionally, digital platforms can help manage negative emotions, which is important for reducing self-harm. Early results from similar programs suggest they can be useful for managing self-harm in young people.14567

Are You a Good Fit for This Trial?

This trial is for teens aged 14-18 who have engaged in nonsuicidal self-injury at least twice in the past month, can understand English well enough to use the app and consent, and have access to a smartphone. Participants should not currently be receiving mental health treatment.

Inclusion Criteria

Current NSSI on 2 or more days in the last month
English language skills sufficient to engage in the consent and intervention procedures
Access to smartphone
See 1 more

Exclusion Criteria

Severe suicide risk including suicidal ideation with a plan and intent to act
I am currently seeing a therapist or counselor.
Severe mental health diagnoses for which this intervention would be inappropriate including psychotic disorders and active manic episodes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week digital mental health intervention (DMHI) or an active psychoeducational control

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including help-seeking activities and NSSI behavior

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • App-based digital mental health intervention for adolescent NSSI

Trial Overview

The study compares two app-based approaches: one group uses an interactive digital mental health program designed for self-injury, while the other receives general healthy living information through the same app. The goal is to see if these methods are practical and acceptable.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Self-guided digital intervention for NSSIExperimental Treatment1 Intervention
Group II: Self-guided delivery of healthy living psychoeducational materialsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

A Smartphone-Based Psychological Intervention for ... - PMC

This study will provide evidence on the effectiveness of a mobile app–based intervention for NSSI and will explore potential mechanisms of ...

Developing a Mobile App for Young Adults with Nonsuicidal ...

Digital interventions have also been associated with significant improvements in common mental health conditions such as depression and anxiety [16,17,18].

Kalmer, a specific based-App intervention for the treatment ...

The primary function of non-suicidal self-injury (NSSI) is thought to involve the regulation of negative emotions and the restoration of ...

Digital interventions for nonsuicidal self-injury. - APA PsycNet

This chapter focuses on digital interventions for nonsuicidal self-injury. In line with the presence and influence of new media in daily life, ...

Digital Mental Health Intervention for Nonsuicidal Self ...

This is a feasibility trial of a digital mental health intervention aimed at young adults (ages 18-25) with nonsuicidal self-injury and who are not ...

Digital Interventions for Adolescents and Young Adults ... - PMC

A recent broad review evaluating the quality, features, functions, and prevention strategies of mobile apps for suicide and NSSI produced ...

Kalmer, a specific based-App intervention for the treatment ...

These findings support the feasibility of Kalmer as a complementary tool in NSSI treatment and lay groundwork for future clinical trials in public health ...