Recruiting

Digital Mental Health Intervention

Sponsor:

Northwestern University

Code:

NCT07224165

Conditions

Nonsuicidal Self-injury

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Interventions

App-based digital mental health intervention for adolescent NSSI

App-based delivery of healthy living psychoeducational materials

Study Details

Brief summary:

This is a feasibility trial of a digital mental health intervention aimed at adolescents (ages 14-18) with nonsuicidal self-injury and who are not currently engaged in mental health treatment. The study has two arms: a self-guided DMHI and 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.

Conditions

Nonsuicidal Self-injury

Depression

Anxiety

Study ID

NCT07224165

Start date

Jun 4, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Current NSSI (NSSI on 2 or more days in the last month
  • English language skills sufficient to engage in the consent and intervention procedures
  • Age 14-18
  • Access to smartphone

Exclusion Criteria:

  • Severe mental health diagnoses for which this intervention would be inappropriate (psychotic disorders, active manic episodes)
  • Severe suicide risk, including suicidal ideation with a plan and intent to act
  • Current engagement in psychotherapy

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Self-guided digital intervention for NSSI

This is the experimental condition

active comparator: Self-guided delivery of healthy living psychoeducational materials

This is the comparison condition

Interventions

App-based digital mental health intervention for adolescent NSSI

The digital intervention for NSSI is an app-based intervention consisting of 16 modules (8 focused on internal skills and 8 focused on external sources of support) to be delivered twice weekly for 8 weeks. Modules containing psychoeducation and skill-based practice, and brief assessments. All content is delivered by a highly interactive conversational agent that guides users through the app content via a text-like interface. Psychoeducational content and strategies center on cognitive behavioral principles and support increased knowledge of external sources of support. Brief assessments examine NSSI and use of skills.

App-based delivery of healthy living psychoeducational materials

The control intervention is an app-based adolescent healthy living intervention consisting of 16 modules containing psychoeducation (e.g., sleep hygiene, water intake, exercise). Modifications will be made to an existing intervention used as a control in prior studies, 1,2 to mitigate potential contraindication for participants with eating disorder comorbidity by replacing nutrition with sun exposure content and an expansion of module content on sleep hygiene and exercise. Like the treatment app, all content in the control app is delivered by a highly interactive conversational agent that guides users through the app content via a text-like interface. Psychoeducational content and psychological strategies delivered center on stress management and healthy living.

Primary outcome measure

  • Actual help-seeking questionnaire (AHSQ) [ Time Frame: 16 weeks ]
  • Alexian Brothers Assessment of Self-Injury - Methods checklist [ Time Frame: 16 weeks ]
  • Acceptability of Intervention Measure (AIM) [ Time Frame: 8 weeks ]
  • Intervention Appropriateness Measure (IAM) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Kaylee Kruzan, PhD, LCSW

312-503-3114kaylee.kruzan@northwestern.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kaylee Kruzan

3125033114kaylee.kruzan@northwestern.edu

More Information

Sponsor

Northwestern University

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-07-08.