Digital Mental Health Intervention for Nonsuicidal Self-Injury in Young Adults

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Anxiety; Suicidal Ideation; Nonsuicidal Self Injury
• Intervention / Treatment: Behavioral: Self-guided digital intervention for NSSI; Behavioral: Digital intervention for NSSI with coaching; Behavioral: Active control

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaylee P Kruzan, PhD; Phone Number: 312-503-3114; Email: kaylee.kruzan@northwestern.edu
• Study Contact Backup: Name: David C Mohr, PhD; Phone Number: 312-503-1403; Email: d-mohr@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-guided digital intervention for NSSI; 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.	Behavioral: Self-guided digital intervention for NSSI; 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.
Experimental: Digital intervention for NSSI with coaching; 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.	Behavioral: Digital intervention for NSSI with coaching; 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 Comparator: Active control; The active control arm will receive 8 weekly modules with psychoeducational components only, without the interaction features or EMA for personalization.	Behavioral: Active control; Psychoeducational content and psychological strategies center on cognitive behavioral principles and acceptance-based emotional regulation strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9	10-item self-report measure assessing depression symptom severity. Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 27.	16 weeks
Generalized Anxiety Disorder-7	8-item self-report measure assessing generalized anxiety disorder symptom severity. Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 21.	16 weeks
Borderline Evaluation of Severity Over Time	15-item self-report measure assessing borderline symptom severity. Higher scores mean greater symptom severity. Three domains: Thoughts and Feelings, Behaviors-Negative, Behaviors-Positive. Minimum score: 12; maximum score: 72.	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.	16 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: David C Mohr, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Smartphone; mHealth; Coach; Conversational Agent; Mobile phone; Digital Mental Health; Nonsuicidal Self Injury
• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Wounds and Injuries; Suicidal Ideation; Self-Injurious Behavior
• Other Study ID Numbers: R34MH128410 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available after publication of the primary outcome papers.
• IPD Sharing Access Criteria: The NIMH Data Archive is managed by the NIMH. Access criteria are determined by the NIMH.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No