Digital Mental Health Service for Non-Treatment Seeking Young Adults
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Northwestern University
- Study ID
- NCT04948268
- Status
- Completed
Conditions
- Anxiety
- Depression
- Suicidal Ideation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 25 Years
- Healthy Volunteers
- Not accepted
Interventions
- Adaptive messaging intervention — BEHAVIORALPsychological content and messages delivered regularly over an 8-week period via interactive SMS messages. Content and messages will be tailored using machine learning.
- Non-personalized messaging intervention — BEHAVIORALPsychological content and messages delivered regularly over an 8-week period via interactive SMS messages. Psychological content will center on a single psychological strategy each week. There will not be any tailoring of messaging and content based on group or individual level data.
- Coaching — BEHAVIORALHuman coaching to support intervention use and engagement via telephone calls, text or email
- Psychoeducational links — BEHAVIORALSMS messages with URLs containing brief psychoeducational information.
Study Details
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.
Key Dates
- Start date
- Oct 27, 2023
- Status verified
- Jan 2026
- Primary completion
- Oct 23, 2024
- Completion
- Oct 25, 2024
Study Design
- Enrollment
- 120 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Adaptive digital mental health intervention without coachingThe adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences.
- Experimental: Non-personalized digital Mental Health intervention without coachingThe non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.
- Experimental: Adaptive digital mental health intervention with coachingThe adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences. Coaching will be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).
- Experimental: Non-personalized digital Mental Health intervention with coachingThe non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage. Coaching will be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).
- Active Comparator: Active controlThe active control condition will provide brief text messages that include a URL link to psychoeducational content, but will not include the interactive messaging component described in experimental arms.
Primary Outcome Measure
Kessler Psychological Distress Scale [ Time Frame: 16 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | - |
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