Clinical trial NCT05325944: Digital Mental Health Intervention for Nonsuicidal Self-Injury in Young Adults
Official title: Digital Mental Health Intervention for Nonsuicidal Self-Injury in Young Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nonsuicidal Self Injury
Suicidal Ideation
Depression
Anxiety
Keywords: Digital Mental Health
Nonsuicidal Self Injury
mHealth
Mobile phone
Smartphone
Coach
Conversational Agent
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alexian Brothers Assessment of Self-Injury - Methods checklist
timeFrame: 16 weeks
measure: Alexian Brothers Urges to Self-Injure Scale
timeFrame: 16 weeks
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: 16 weeks
measure: Generalized Anxiety Disorder-7
timeFrame: 16 weeks
measure: Borderline Evaluation of Severity Over Time
timeFrame: 16 weeks
measure: Depression Symptom Inventory - Suicidality Subscale
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Kaylee C Kruzan, PhD
role: PRINCIPAL_INVESTIGATOR
References: