Digital Mental Health Intervention for Nonsuicidal Self-Injury in Young Adults
1 other identifier
interventional
90
1 country
1
Brief Summary
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 currently engaged in mental health treatment. We will pilot three arms: a self-guided DMHI, the DMHI with low-intensity coaching, or an active control which will involve the delivery of non-interactive psychoeducational content via the same app interface. The primary goals of this project are to evaluate the feasibility of the intervention and trial procedures in preparation for a fully-powered randomized-controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2022
CompletedFirst Posted
Study publicly available on registry
April 13, 2022
CompletedStudy Start
First participant enrolled
August 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2025
CompletedApril 16, 2026
April 1, 2025
1 year
April 4, 2022
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Alexian Brothers Assessment of Self-Injury - Methods checklist
16-item checklist that assesses the frequency (days/times) of common NSSI methods within the past month.
16 weeks
Alexian Brothers Urges to Self-Injure Scale
5-item self-report measure assessing the intensity and frequency of NSSI urges. Higher scores mean more intense urges to self-injure. Minimum score: 0; maximum score: 30.
16 weeks
Secondary Outcomes (4)
Patient Health Questionnaire-9
16 weeks
Generalized Anxiety Disorder-7
16 weeks
Borderline Evaluation of Severity Over Time
16 weeks
Depression Symptom Inventory - Suicidality Subscale
16 weeks
Study Arms (3)
Self-guided digital intervention for NSSI
EXPERIMENTALThe 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.
Digital intervention for NSSI with coaching
EXPERIMENTALThe 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.
Active control
ACTIVE COMPARATORThe active control arm will receive 8 weekly modules with psychoeducational components only, without the interaction features or EMA for personalization.
Interventions
Psychoeducational content, skill-based practice, and daily ecological momentary assessments will be delivered over an 8-week period. Psychological strategies center on cognitive behavioral principles and acceptance-based emotional regulation strategies. Daily EMAs assess NSSI and use of cognitive, behavioral, and emotion regulatory strategies.
Psychoeducational content and psychological strategies center on cognitive behavioral principles and acceptance-based emotional regulation strategies. Daily EMAs assess NSSI and use of cognitive, behavioral, and emotion regulatory strategies. Human coaching will be used to support intervention use and engagement twice per week via text, call or email.
Psychoeducational content and psychological strategies center on cognitive behavioral principles and acceptance-based emotional regulation strategies.
Eligibility Criteria
You may qualify if:
- Ages 18-24 \*The age to provide consent in Nebraska is 19. Individuals recruited from the state of Nebraska must be 19 or older.
- Current NSSI, defined as self-injury on 2 or more days in the past month
- Has a smartphone
- English language skills sufficient to engage in the consent and intervention procedures
You may not qualify if:
- 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)
- Current engagement in psychotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaylee C Kruzan, PhD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 4, 2022
First Posted
April 13, 2022
Study Start
August 2, 2024
Primary Completion
August 18, 2025
Study Completion
August 18, 2025
Last Updated
April 16, 2026
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available after publication of the primary outcome papers.
- Access Criteria
- The NIMH Data Archive is managed by the NIMH. Access criteria are determined by the NIMH.
De-identified data will be shared through and managed by the NIMH Data Archive (NDA). De-identified human subjects data, harmonized to a common standard, are available to qualified researchers.