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

Eligibility Criteria

Sex
ALL
Age
18 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Adaptive messaging intervention — BEHAVIORAL
    Psychological 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 — BEHAVIORAL
    Psychological 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 — BEHAVIORAL
    Human coaching to support intervention use and engagement via telephone calls, text or email
  • Psychoeducational links — BEHAVIORAL
    SMS 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 coaching
    The 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 coaching
    The 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 coaching
    The 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 coaching
    The 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 control
    The 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)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-

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