Digital Mental Health Service for Non-Treatment Seeking Young Adults
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Oct 2023
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2021
CompletedFirst Posted
Study publicly available on registry
July 1, 2021
CompletedStudy Start
First participant enrolled
October 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2024
CompletedResults Posted
Study results publicly available
February 9, 2026
CompletedFebruary 9, 2026
January 1, 2026
12 months
June 16, 2021
December 5, 2025
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Kessler Psychological Distress Scale
10-item self-report measure of transdiagnostic distress, used as outcome measure across diagnostic categories. Higher scores mean greater distress. Minimum score: 10; maximum score: 50
16 weeks
Engagement Length
Last message/content rating or click on content URL link received from participant. This measure can include select individuals who exceed 56 days of interaction due to user's ability to temporarily pause receipt of messages, resulting in messages extending beyond 8 weeks (56 days).
62 days
Secondary Outcomes (2)
Patient Health Questionnaire-9
16 weeks
Generalized Anxiety Disorder-7
16 weeks
Other Outcomes (4)
Depression Symptom Inventory - Suicidality Subscale
16 weeks
Cognitive Behavioral Response to Stress Scale
16 weeks
Objective Engagement Markers: Percent of Messages Responded to
62 days
- +1 more other outcomes
Study Arms (5)
Adaptive digital mental health intervention without coaching
EXPERIMENTALThe 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.
Non-personalized digital Mental Health intervention without coaching
EXPERIMENTALThe 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.
Adaptive digital mental health intervention with coaching
EXPERIMENTALThe 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).
Non-personalized digital Mental Health intervention with coaching
EXPERIMENTALThe 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 control
ACTIVE COMPARATORThe 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.
Interventions
Psychological content and messages delivered regularly over an 8-week period via interactive SMS messages. Content and messages will be tailored using machine learning.
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.
SMS messages with URLs containing brief psychoeducational information.
Human coaching to support intervention use and engagement via telephone calls, text or email
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Loss to follow-up and missing data affect the interpretability of data from this trial (as all trials). Additionally, this trial was powered for feasibility not for efficacy.
Results Point of Contact
- Title
- Jonah Meyerhoff
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
David C Mohr, PhD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 16, 2021
First Posted
July 1, 2021
Study Start
October 27, 2023
Primary Completion
October 23, 2024
Study Completion
October 25, 2024
Last Updated
February 9, 2026
Results First Posted
February 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available after publication of the primary outcome papers.
- Access Criteria
- The NIMH Data Archive is managed by the NIMH. Access criteria are determined by the NIMH.
De-identified data will be shared through and managed by the National Institute of Mental Health (NIMH) Data Archive (NDA). De-identified human subjects data, harmonized to a common standard, are available to qualified researchers.