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Digital Mental Health Intervention for Self-Harm

N/A
Waitlist Available
Led By David C Mohr, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial will test a digital mental health intervention for young adults who self-injure, to see if it is feasible and leads to better outcomes than a control group.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is a digital intervention rather than medication, traditional side effects aren't expected. However, users may experience discomfort or emotional distress when engaging with sensitive content related to NSSI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alexian Brothers Assessment of Self-Injury - Methods checklist
Alexian Brothers Urges to Self-Injure Scale
Secondary outcome measures
Borderline Evaluation of Severity Over Time
Depression Symptom Inventory - Suicidality Subscale
Generalized Anxiety Disorder-7
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Self-guided digital intervention for NSSIExperimental Treatment1 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 coachingExperimental Treatment1 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 controlActive Control1 Intervention
The active control arm will receive 8 weekly modules with psychoeducational components only, without the interaction features or EMA for personalization.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,574 Total Patients Enrolled
66 Trials studying Depression
27,806 Patients Enrolled for Depression
David C Mohr, PhDPrincipal InvestigatorNorthwestern University
6 Previous Clinical Trials
769 Total Patients Enrolled
6 Trials studying Depression
769 Patients Enrolled for Depression

Media Library

Depression Research Study Groups: Active control, Digital intervention for NSSI with coaching, Self-guided digital intervention for NSSI
~60 spots leftby Dec 2024
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