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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05325944
• Other study ID #: R34MH128410
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: Kaylee P Kruzan, PhD
• Phone: 312-503-3114
• Email: kaylee.kruzan[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Nonsuicidal Self Injury
• Self-Injurious Behavior
• Suicidal Ideation
• Wounds and Injuries

Intervention

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.
• 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 control
Psychoeducational content and psychological strategies center on cognitive behavioral principles and acceptance-based emotional regulation strategies.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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