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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
1,585 Previous Clinical Trials
917,141 Total Patients Enrolled
66 Trials studying Depression
28,335 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participants in this research experiment?

"This clinical trial is no longer looking for participants, as confirmed on clinicaltrials.gov; it was initially posted December 1st 2022 and last edited April 12th 2022. Nevertheless, there are 2164 other research studies currently recruiting across the world."

Answered by AI

What is the ultimate objective of this clinical trial?

"The main measure of this 16-week clinical trial is the Alexian Brothers Urges to Self-Injure Scale. Other secondary metrics include the Depression Symptom Inventory - Suicidality Subscale (ranging from 0 to 12), Generalized Anxiety Disorder-7 (from 0 to 21) and Patient Health Questionnaire-9 (from 0 to 27). All these assessments evaluate a patient's propensity for suicidal thoughts, anxiety levels and depression symptoms respectively."

Answered by AI

Does the trial accept participants below the age of 25?

"This experimentation is open to subjects aged between 18 and 24 years old."

Answered by AI

Who would benefit the most from participating in this clinical research?

"This trial is admitting 90 people, aged between 18 and 24, who have expressed suicidal thoughts. The prerequisites for enrolment are: having self-harmed on at least two occasions in the past month; possessing a smartphone; holding English language proficiency necessary to consent and complete intervention procedures; being 19 or over if recruited from Nebraska (where the age of legal consent is 19)."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Arkansas
North Carolina
Other
How old are they?
18 - 65
What site did they apply to?
Northwestern University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Digital Mental Health Intervention for Nonsuicidal Self-Injury in Young Adults
David Mohr 2024. "Digital Mental Health Intervention for Nonsuicidal Self-Injury in Young Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05325944.
~60 spots leftby Dec 2024
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