Nonsuicidal Self InjuryNCT05325944
Digital Mental Health Intervention for Nonsuicidal Self-Injury in Young Adults
A study testing Self-guided digital intervention for NSSI and Digital intervention for NSSI with coaching in people with Nonsuicidal Self Injury and Suicidal Ideation, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Nonsuicidal Self Injury, Suicidal Ideation, Depression
- What is being tested?
- Self-guided digital intervention for NSSI and Digital intervention for NSSI with coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2024to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The primary purpose of this trial is to test the feasibility of conducting a randomized controlled trial (RCT) of an 8-week digital mental health intervention (DMHI) for non-treatment engaged young adults with repeated nonsuicidal self-injury. The DMHI will be a highly interactive conversational agent that conveys psychoeducational content and guides participants through skill-based activities. We will conduct a 3-arm feasibility trial, randomizing participants to receive the 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. Initial randomization will be generated in permuted blocks of 6 using a computer program, with participants assigned on a 1:1:1 ratio. To prevent allocation bias, randomization will be conducted by the biostatistician, who will not inform the study team of the treatment arms until the baseline assessment has been completed and the patient has been enrolled. The control group will serve as the reference group to verify the effectiveness of the DMHI while the comparison of self-guided to coached deployments will evaluate the added benefit of coaching.
The primary clinical outcome measures will be frequency of NSSI behavior (ABASI) and frequency of NSSI urges (ABUSI). Secondary outcomes will include suicidal ideation (DSI-SS), depressive symptom severity (PHQ-9), and anxiety symptom severity (GAD-7).
This study will enroll individuals who have meet the following eligibility criteria: 1) current NSSI, defined as 2+ self-injury episodes (e.g., cutting, burning) in the past month; 2) Age 18 to 24; 3) English language skills sufficient to engage in the consent and intervention procedures. Participants will be excluded if they 1) Have a severe mental illness diagnosis (e.g., psychotic disorder); 2) Are imminently suicidal, with a plan and intent; or 3) Are currently receiving psychotherapy.
Coaching will consist of providing users with support and accountability via positive reinforcement, goal and expectation setting, and monitoring. Coaching outreach will focus on adherence to the treatment but will not provide treatment advice. Coaches will provide a brief (20-30 minute phone call or equivalent depending on the medium) engagement phone call. Thereafter, coaches will check in with participants via messaging, phone call, or email, twice per week and respond to patient messages.
- Conditions
- Nonsuicidal Self Injury, Suicidal Ideation, Depression, Anxiety
- Being tested
- Self-guided digital intervention for NSSI, Digital intervention for NSSI with coaching, Active control
- Keywords
- Digital Mental Health, Nonsuicidal Self Injury, mHealth, Mobile phone, Smartphone, Coach, Conversational Agent
- Medical subject headings
- Self-Injurious Behavior, Suicidal Ideation, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-guided digital intervention for NSSIBehavioural
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.
Digital intervention for NSSI with coachingBehavioural
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.
Active controlBehavioural
Psychoeducational content and psychological strategies center on cognitive behavioral principles and acceptance-based emotional regulation strategies.
| Study group | Role | What they receive |
|---|---|---|
| Self-guided digital intervention for NSSI | Experimental | 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. Receives: Behavioral: Self-guided digital intervention for NSSI |
| Digital intervention for NSSI with coaching | Experimental | 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. Receives: Behavioral: Digital intervention for NSSI with coaching |
| Active control | Active comparator | The active control arm will receive 8 weekly modules with psychoeducational components only, without the interaction features or EMA for personalization. Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. Higher scores indicate engagement in NSSI on more days. Minimum: 0 days; Maximum: 31 days
Measured: 16 weeks
Alexian Brothers Urges to Self-Injure Scale
5-item self-report measure assessing the frequency of urges to self-injure, intensity of urges, time spent thinking about self-injury, ability to resist urges and thoughts associated with self-injury urges. Each item is scored on a 7-point Likert scale from 1 to 7. Scores are summed to produce a total score ranging from 5 to 35. Score is averaged across items here. Higher scores indicate stronger urges to self-injure.
Measured: 16 weeks
Secondary outcomes (4)
Patient Health Questionnaire-9
10-item self-report measure assessing depression symptom severity over the past two weeks. Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 27.
Measured: 16 weeks
Generalized Anxiety Disorder-7
7-item self-report measure assessing generalized anxiety disorder symptom severity. Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 21.
Measured: 16 weeks
Borderline Evaluation of Severity Over Time
15-item, self-report measure of the severity of and changes in borderline personality disorder (BPD) symptoms. The BEST has 3 subscales: A (Thoughts and Feelings); B (Behaviors-Negative), and C (Behaviors-Positive). All items are scored on a 1-5 rating scale, where higher numbers show greater distress or higher frequency of actions. Subscale C is reverse scored. Total score is calculated as the sum of subscale A + sum of subscale B - sum of subscale C + 15 (correction). Total scores range from 12 (best) to 72 (worst); higher scores are associated with higher levels of BPD symptoms.
Measured: 16 weeks
Depression Symptom Inventory - Suicidality Subscale
4-item self-report questionnaire assessing the frequency and intensity of suicidal thoughts over previous two weeks. Higher scores signal greater frequency and severity of suicidal thoughts. Minimum score: 0; maximum score: 12.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start2 Aug 2024
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonsuicidal Self InjuryStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaylee C Kruzan, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325944
- Sponsor's protocol ID
- R34MH128410
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2022
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Mental Health Intervention for Nonsuicidal Self-Injury in Young Adults
- ClinicalTrials.gov ID
- NCT05325944
- Acronym / sponsor ID
- R34MH128410
- Conditions
- Nonsuicidal Self Injury, Suicidal Ideation, Depression, Anxiety
- Keywords
- Digital Mental Health, Nonsuicidal Self Injury, mHealth, Mobile phone, Smartphone, Coach, Conversational Agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Posted 29 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary purpose of this trial is to test the feasibility of conducting a randomized controlled trial (RCT) of an 8-week digital mental health intervention (DMHI) for non-treatment engaged young adults with repeated nonsuicidal self-injury. The DMHI will be a highly interactive conversational agent that conveys psychoeducational content and guides participants through skill-based activities. We will conduct a 3-arm feasibility trial, randomizing participants to receive the 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. Initial randomization will be generated in permuted blocks of 6 using a computer program, with participants assigned on a 1:1:1 ratio. To prevent allocation bias, randomization will be conducted by the biostatistician, who will not inform the study team of the treatment arms until the baseline assessment has been completed and the patient has been enrolled. The control group will serve as the reference group to verify the effectiveness of the DMHI while the comparison of self-guided to coached deployments will evaluate the added benefit of coaching.
The primary clinical outcome measures will be frequency of NSSI behavior (ABASI) and frequency of NSSI urges (ABUSI). Secondary outcomes will include suicidal ideation (DSI-SS), depressive symptom severity (PHQ-9), and anxiety symptom severity (GAD-7).
This study will enroll individuals who have meet the following eligibility criteria: 1) current NSSI, defined as 2+ self-injury episodes (e.g., cutting, burning) in the past month; 2) Age 18 to 24; 3) English language skills sufficient to engage in the consent and intervention procedures. Participants will be excluded if they 1) Have a severe mental illness diagnosis (e.g., psychotic disorder); 2) Are imminently suicidal, with a plan and intent; or 3) Are currently receiving psychotherapy.
Coaching will consist of providing users with support and accountability via positive reinforcement, goal and expectation setting, and monitoring. Coaching outreach will focus on adherence to the treatment but will not provide treatment advice. Coaches will provide a brief (20-30 minute phone call or equivalent depending on the medium) engagement phone call. Thereafter, coaches will check in with participants via messaging, phone call, or email, twice per week and respond to patient messages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-guided digital intervention for NSSI | Experimental | Behavioral: Self-guided digital intervention for NSSIThe 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 | Experimental | Behavioral: Digital intervention for NSSI with coachingThe 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 comparator | Behavioral: Active controlThe active control arm will receive 8 weekly modules with psychoeducational components only, without the interaction features or EMA for personalization. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-guided digital intervention for NSSIPsychoeducational 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. | Behavioural | Self-guided digital intervention for NSSI |
| Digital intervention for NSSI with coachingPsychoeducational 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. | Behavioural | Digital intervention for NSSI with coaching |
| Active controlPsychoeducational content and psychological strategies center on cognitive behavioral principles and acceptance-based emotional regulation strategies. | Behavioural | Active control |
Primary outcome
Alexian Brothers Assessment of Self-Injury - Methods Checklist
Time frame: 16 weeks
16-item checklist that assesses the frequency (days/times) of common NSSI methods within the past month. Higher scores indicate engagement in NSSI on more days. Minimum: 0 days; Maximum: 31 days
Alexian Brothers Urges to Self-Injure Scale
Time frame: 16 weeks
5-item self-report measure assessing the frequency of urges to self-injure, intensity of urges, time spent thinking about self-injury, ability to resist urges and thoughts associated with self-injury urges. Each item is scored on a 7-point Likert scale from 1 to 7. Scores are summed to produce a total score ranging from 5 to 35. Score is averaged across items here. Higher scores indicate stronger urges to self-injure.
4 secondary outcomes
Patient Health Questionnaire-9
Time frame: 16 weeks
Generalized Anxiety Disorder-7
Time frame: 16 weeks
Borderline Evaluation of Severity Over Time
Time frame: 16 weeks
Depression Symptom Inventory - Suicidality Subscale
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Nonsuicidal Self Injury
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Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients
Borderline Personality Disorder (BPD)
Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
Self Injurious Behavior, Self Injurious Behavior Without Suicidal Intent
Recruiting
Neurobiological Markers of Non-suicidal Self-injury and Treatment Mechanisms of Adolescent Self-injury Intervention Skills Training
Non-suicidal Self-injury (NSSI), Adolescent
Recruiting
Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
Non-suicidal Self-injury (NSSI)
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Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
Aggressive Behavior in Fragile X Syndome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaylee C Kruzan, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-guided digital intervention for NSSI and Digital intervention for NSSI with coaching in people with Nonsuicidal Self Injury and Suicidal Ideation, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alexian Brothers Assessment of Self-Injury - Methods Checklist (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.