Depression Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
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 |
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