Digital Mental Health Intervention for Self-Harm

Overseen by Kaylee C Kruzan, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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, with some users also getting support from coaches. The goal is to see if the app is feasible for a larger study.

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.

What data supports the effectiveness of the digital mental health intervention for self-harm?

Research shows that online interventions can be effective for mental health issues like depression and anxiety, and they offer high confidentiality and accessibility, which is beneficial for adolescents with low help-seeking behavior. Although there is no direct evidence for online interventions specifically for nonsuicidal self-injury (NSSI), the development of such interventions is based on successful short-term programs for NSSI, suggesting potential effectiveness. ^{1 2 3 4 5}

Is the Digital Mental Health Intervention for Self-Harm safe for humans?

The available research does not provide specific safety data for the Digital Mental Health Intervention for Self-Harm, but online interventions for mental health issues like depression and anxiety have shown some evidence of safety. However, the risks associated with online activities related to self-harm, such as reinforcement of harmful behaviors, should be considered. ^{1 3 4 6 7}

How is the Digital Mental Health Intervention for Self-Harm different from other treatments for self-harm?

This digital intervention is unique because it provides online support specifically for nonsuicidal self-injury (NSSI), making it accessible to adolescents and young adults who may not seek traditional therapy. It offers a confidential and location-independent option, which is particularly beneficial for those with low help-seeking behavior. ^{2 3 8 9 10}

Research Team

Kaylee C Kruzan, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

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

I am between 18 and 24 years old, or 19 and 24 if I live in Nebraska.

Has a smartphone

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

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)

Trial Timeline

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

Treatment Details

Interventions

• Active control (Behavioural Intervention)
• Digital intervention for NSSI with coaching (Behavioural Intervention)
• Self-guided digital intervention for NSSI (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States 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. [2023]

2. Switzerland 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. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Development of an Online Intervention for Adolescents and Young Adults Engaging in Nonsuicidal Self-injury]. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Non-suicidal self-injury, youth, and the Internet: What mental health professionals need to know. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

How Technologies Can Support Self-Injury Self-Management: Perspectives of Young Adults With Lived Experience of Nonsuicidal Self-Injury. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Nonsuicidal Self-Injury: A Nurse-Led Quality Improvement Project to Address Self-Harm. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Treating nonsuicidal self-injury: a systematic review of psychological and pharmacological interventions. [2019]

8. Canada 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. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health Technology Interventions for Suicide Prevention: Systematic Review. [2022]

10. England 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. [2022]