Digital Mental Health Intervention for Self-Harm

Overseen By David C Mohr, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Psychotic disorder, Manic episode, Severe suicidality, Psychotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital mental health app designed to assist young adults with a history of self-injury (self-harm without suicidal intent) who are not currently seeing a therapist. The study compares three approaches: the app alone (self-guided digital intervention for NSSI), the app with coaching (digital intervention for NSSI with coaching), and basic educational content through the app (active control). The main goal is to determine if this app can be effectively used in a larger future study. Ideal participants are young adults who have self-injured at least twice in the past month and own a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions for young adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on participants not currently engaged in mental health treatment.

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

Research shows that digital tools for managing nonsuicidal self-injury (NSSI) are generally well-received. Many studies have explored the use of digital mental health tools for young adults who self-injure, often incorporating apps with educational content and activities.

While detailed safety data for these digital tools isn't always available, earlier research on similar digital mental health tools suggests they are usually safe. Users rarely report serious problems, and common feedback highlights the apps' ease of use and helpful content.

Digital tools that include coaching can offer more personalized support, potentially improving the overall experience. A coach can help users feel more connected and supported, enhancing safety and satisfaction.

Overall, digital mental health tools for self-injury appear to be a promising and safe option for those not currently receiving traditional mental health care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these digital interventions for non-suicidal self-injury (NSSI) because they offer a novel and accessible approach to mental health care. Unlike traditional therapy, which often requires in-person sessions, these interventions utilize a digital platform with interactive modules and a conversational agent to deliver psychoeducation and skill-based practice. One of the treatments also includes lightweight coaching, providing personalized support through regular check-ins. This innovative delivery method not only increases accessibility for individuals who might not have easy access to traditional therapy but also allows for real-time engagement and support, making it a promising option for those struggling with self-harm.

What evidence suggests that this trial's treatments could be effective for nonsuicidal self-injury?

Research has shown that digital tools can improve mental health issues like depression and anxiety. One study found these tools effective for young people dealing with self-harm by offering educational content and activities. In this trial, participants may receive a self-guided digital intervention for nonsuicidal self-injury (NSSI), with or without coaching. A coach provides additional support and guidance. Designed for ease of use, these digital tools offer a good option for those not currently receiving mental health treatment. Early results are promising, particularly in helping young adults manage self-harming behaviors. ^{1 2 3 4 6}

Who Is on the Research Team?

Kaylee C Kruzan, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-25 who self-injure, are not in therapy, and don't have severe suicidal thoughts or serious mental illnesses like psychosis. Participants must own a smartphone and understand English well enough to consent and use the app.

Inclusion Criteria

Has a smartphone

English language skills sufficient to engage in the consent and intervention procedures

Current NSSI, defined as self-injury on 2 or more days in the past month

Exclusion Criteria

I am currently seeing a therapist for mental health support.

Serious mental illness for which intervention would be contraindicated (e.g., psychotic disorder, manic episode, etc.)

Severe suicidality (i.e., experiencing suicidal ideation with a plan and intent to act)

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) for nonsuicidal self-injury, with options for self-guided or coached support

8 weeks

1 initial engagement call, followed by twice-weekly check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active control
• Digital intervention for NSSI with coaching
• Self-guided digital intervention for NSSI

Trial Overview The study tests a digital mental health intervention (DMHI) for nonsuicidal self-injury (NSSI). It has three parts: one with just the app, another adds coaching to the app, and a control group gets educational content through the app without interaction.

How Is the Trial Designed?

Group I: Self-guided digital intervention for NSSI Experimental Treatment 1 Intervention

The self-guided digital intervention for NSSI will consist of 8 weekly modules containing psychoeducation and skill-based practice, and daily ecological momentary assessments. All content is delivered by a highly interactive conversational agent that guides users through the app content via a text-like interface.

Group II: Digital intervention for NSSI with coaching Experimental Treatment 1 Intervention

The self-guided digital intervention for NSSI will consist of 8 weekly modules containing psychoeducation and skill-based practice, and daily ecological momentary assessments. All content is delivered by a highly interactive conversational agent that guides users through the app content via a text-like interface. This arm will additionally receive lightweight coaching which consists of a one 20-30 minute engagement call at the beginning of treatment. Thereafter, coaches will check in with participants via medium of participants choice twice per week and respond to patient texts, calls, or emails.

Group III: Active control Active Control 1 Intervention

The active control arm will receive 8 weekly modules with psychoeducational components only, without the interaction features or EMA for personalization.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

An online intervention for adolescents and young adults engaging in nonsuicidal self-injury (NSSI) has been developed to address the lack of accessible treatment options, especially for those with low help-seeking behavior.

This intervention is based on a previously evaluated program and will be tested for its efficacy in a randomized controlled trial, aiming to provide effective support for a prevalent issue among youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of an Online Intervention for Adolescents and Young Adults Engaging in Nonsuicidal Self-injury]. Edinger, A., Koenig, J., Bauer, S., et al.[2020]

Digital interventions, such as apps, showed a reduction in suicidal ideation scores among 3,356 participants across 14 studies, suggesting they may be more effective than simply waiting for treatment.

However, there was no evidence that these interventions reduced self-harm or suicide attempts, and many studies had design biases, indicating that more research is needed to confirm their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of online and mobile telephone applications ('apps') for the self-management of suicidal ideation and self-harm: a systematic review and meta-analysis. Witt, K., Spittal, MJ., Carter, G., et al.[2022]

A review of 7 studies on mobile health (mHealth) apps for suicide prevention showed some positive effects, such as reduced depression and increased coping self-efficacy, but none significantly decreased suicidal ideation compared to control groups.

The review highlights the need for more rigorous research and standardized outcome measures in evaluating mHealth interventions, as current studies exhibit methodological limitations that affect their generalizability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Technology Interventions for Suicide Prevention: Systematic Review. Melia, R., Francis, K., Hickey, E., et al.[2022]

The pilot studies involving 21 LGBTQ+ youth and 19 racial and ethnic minority youth demonstrated that the Purrble intervention was feasible and acceptable, with participants reporting a decrease in self-harmful thoughts and anxiety symptoms during the 3-week study period.

Qualitative feedback indicated that Purrble effectively helped young people adopt emotion regulation strategies and interrupt the cycle of self-harm, highlighting its potential as a supportive tool in moments of emotional distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the Feasibility, Acceptability, and Appropriation of a Socially Assistive Robot Among Minority Youth at Risk of Self-Harm: Results of 2 Mixed Methods Pilot Studies. Williams, AJ., Townsend, E., Naeche, N., et al.[2023]

Adolescents with nonsuicidal self-injury (NSSI) expressed a strong interest in smartphone-based mental health interventions, provided they are perceived as helpful, relevant, and user-friendly, highlighting the importance of tailoring these tools to their specific needs.

The study developed a framework emphasizing that effective digital mental health interventions should consider the individual user, their mental health condition, and technology-related factors, necessitating collaboration among adolescents, mental health professionals, and technology experts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Smartphone Apps Are Cool, But Do They Help Me?": A Qualitative Interview Study of Adolescents' Perspectives on Using Smartphone Interventions to Manage Nonsuicidal Self-Injury. Čuš, A., Edbrooke-Childs, J., Ohmann, S., et al.[2021]

Nonsuicidal self-injury (NSSI) behaviors are often linked with various mental health disorders, complicating treatment and increasing the workload for healthcare providers.

A nurse-led quality improvement project demonstrated enhanced staff competencies and policies for managing NSSI, although implementing these changes remains challenging due to existing time constraints on care providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsuicidal Self-Injury: A Nurse-Led Quality Improvement Project to Address Self-Harm. Goodman, D., Pletch, A., Paul, P., et al.[2022]

Several psychological interventions, such as dialectical behaviour therapy and emotion regulation group therapy, show promise in effectively reducing nonsuicidal self-injury (NSSI), based on a systematic review of existing treatments.

Medications like atypical antipsychotics and selective serotonin reuptake inhibitors also demonstrate benefits for NSSI, but more well-controlled studies are needed to better understand their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating nonsuicidal self-injury: a systematic review of psychological and pharmacological interventions. Turner, BJ., Austin, SB., Chapman, AL.[2019]

The study assessed the feasibility of an internet-based therapy called Emotion Regulation Individual Therapy for Adolescents (ERITA) for adolescents aged 13-17 who engage in non-suicidal self-injury (NSSI), involving 30 participants in a randomized trial.

While 90% of participants completed follow-up interviews and 87% completed most of the ERITA modules, the therapy did not show a significant difference in reducing NSSI compared to standard treatment, indicating the need for further large-scale trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet based intervention (Emotion Regulation Individual Therapy for Adolescents) as add-on to treatment as usual versus treatment as usual for non-suicidal self-injury in adolescent outpatients: The TEENS randomised feasibility trial. Morthorst, B., Olsen, MH., Jakobsen, JC., et al.[2023]

Many young people who engage in non-suicidal self-injury (NSSI) turn to the Internet for peer support, but this can also expose them to risks such as reinforcement of self-injury behaviors and triggering urges to self-injure.

Mental health professionals need to be aware of these online risks and should use tailored assessments and interventions, including motivational interviewing, to help adolescents replace harmful online activities with healthier ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-suicidal self-injury, youth, and the Internet: What mental health professionals need to know. Lewis, SP., Heath, NL., Michal, NJ., et al.[2021]

A study involving 20 young adults aged 18-24 revealed that individuals who engage in nonsuicidal self-injury (NSSI) often lack effective strategies for managing their urges and expressed a strong interest in app-based technologies that could help track their behaviors and provide personalized self-management suggestions.

Participants reported using existing technologies for self-management and sought online support, indicating a need for digital interventions that are flexible and tailored to individual experiences and recovery phases related to NSSI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Technologies Can Support Self-Injury Self-Management: Perspectives of Young Adults With Lived Experience of Nonsuicidal Self-Injury. Kruzan, KP., Mohr, DC., Reddy, M.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05325944

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9739032/

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].

3. withpower.com withpower.com/trial/phase-self-injurious-behavior-11-2022-824e3

Digital Mental Health Intervention for Self-Harm This trial tests a digital mental health app for young adults who self-injure but aren't in treatment. The app offers educational content and activities, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11548831/

Digital Interventions for Adolescents and Young Adults ... To summarize literature on digital mental health interventions (DMHIs) for self-injurious thoughts and behaviors (SITBs) among adolescents and young adults.

5. acamh.onlinelibrary.wiley.com acamh.onlinelibrary.wiley.com/doi/10.1111/jcpp.70054

Brief digital psychological intervention to prevent relapse of ... Non-suicidal self-injury (NSSI) poses a significant mental health challenge among adolescents, necessitating accessible and effective ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2214782925000272

Delivering real-time support for self-injury: A systematic ... This systematic review aims to assess the efficacy and feasibility of smartphone-based EMIs in reducing SITB and improving mental health outcomes.