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

Northwestern University

Status: Active, not recruiting

Conditions: Nonsuicidal Self Injury; Suicidal Ideation; Depression; Anxiety

Treatments: Behavioral: Self-guided digital intervention for NSSI; Behavioral: Active control; Behavioral: Digital intervention for NSSI with coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT05325944

R34MH128410

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Self-guided digital intervention for NSSI

Experimental group

Description:

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.

Treatment:

Behavioral: Self-guided digital intervention for NSSI

Digital intervention for NSSI with coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Digital intervention for NSSI with coaching

Active control

Active Comparator group

Description:

The active control arm will receive 8 weekly modules with psychoeducational components only, without the interaction features or EMA for personalization.

Treatment:

Behavioral: Active control