N/A
Completed N=120
Digital Mental Health Service for Non-Treatment Seeking Young Adults
Source: ClinicalTrials.gov NCT04948268 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Kessler Psychological Distress Scale — 23.52; 23.54; 24.50; 23.78 Score
Summary
This is a feasibility trial of a personalized 8-week text messaging intervention aimed at young adults (ages 18-25) with depression and anxiety who are not interested in -- or experience barriers to -- receiving traditional face-to-face psychological treatments.
The trial will consist of a pilot test of (1) an 8-week adaptive (personalized) messaging intervention relative to (2) a non-personalized digital mental health intervention, or (3) an active control which will send weekly psychoeducation information by way of Uniform Resource Locators (URLs). The adaptive intervention will uses machine learning to tailor Short Message Service (SMS) messages to an individual's needs and preferences, and URL links to provide access to psychoeducational content to contextualize messages, when the length of that content exceeds the limitations of messages.
The primary goals of the project are to conduct a feasibility trial using a sequential multiple assignment randomized treatment (SMART) design, which will evaluate (a) the effectiveness of an adaptive, personalized messaging intervention in reducing engagement relative to a non-personalized version; and (b) whether human coaching results in greater symptom reduction and engagement, relative an unguided implementation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kessler Psychological Distress Scale |
23.52; 23.54; 24.50; 23.78; 26.58 | — |
| PRIMARY Engagement Length |
51.4; 54.2; 36.2; 56.2; 50.1 | — |
| SECONDARY Patient Health Questionnaire-9 |
9.59; 8.79; 9.83; 9.50; 11.77 | — |
| SECONDARY Generalized Anxiety Disorder-7 |
7.93; 7.54; 4.67; 7.37; 9.47 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 18 to 25 *The age to provide consent in Nebraska is 19. Individuals recruited from the state of Nebraska must be 19 or older.
- A positive screen on an MHA screen for depression (Patient Health Questionnaire - 9 [PHQ-9]) or anxiety (Generalized Anxiety Disorder - 7 [GAD-7]);
- Resident of the United States.
- Owns a smartphone
Exclusion Criteria
- Current treatment with psychotherapy or psychiatric medication management;
- Seeking or plans to seek traditional mental health treatment (psychotherapy or psychiatric medication management) in next 8 weeks;
- 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);
- English insufficient to engage in design activities.
Data sourced from ClinicalTrials.gov (NCT04948268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.