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Digital Mental Health Intervention for Depression and Anxiety

N/A
Waitlist Available
Led By David C Mohr, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Seeking or plans to seek traditional mental health treatment (psychotherapy or psychiatric medication management) in next 8 weeks;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Summary

This trial is a test of a personalized 8-week text messaging intervention for young adults with depression and anxiety. The goal is to see if it is more effective than a static digital mental health intervention or an active control.

Who is the study for?
This trial is for young adults aged 18-25 in the US who have depression or anxiety but aren't currently seeking traditional mental health treatment. They must own a smartphone and screen positive for depression or anxiety. Those already in psychotherapy, planning to seek such treatment soon, with severe suicidality, serious mental illness, or insufficient English are excluded.
What is being tested?
The study tests an 8-week text messaging service designed to help with depression and anxiety. It compares personalized messages tailored by machine learning against non-personalized messages and weekly educational content links. The effectiveness of additional human coaching versus no guidance will also be evaluated.
What are the potential side effects?
Since this is a digital intervention focusing on messaging and education rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort from discussing sensitive topics.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I plan to seek mental health treatment soon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Engagement length
Kessler Psychological Distress Scale
Secondary study objectives
Generalized Anxiety Disorder-7
Patient Health Questionnaire-9
Other study objectives
Cognitive Behavioral Response to Stress Scale
Depression Symptom Inventory - Suicidality Subscale
Objective engagement markers

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Non-personalized digital Mental Health intervention without coachingExperimental Treatment1 Intervention
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.
Group II: Non-personalized digital Mental Health intervention with coachingExperimental Treatment2 Interventions
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).
Group III: Adaptive digital mental health intervention without coachingExperimental Treatment1 Intervention
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.
Group IV: Adaptive digital mental health intervention with coachingExperimental Treatment2 Interventions
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).
Group V: Active controlActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coaching
2016
Completed Phase 3
~5600

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,625 Previous Clinical Trials
937,169 Total Patients Enrolled
67 Trials studying Depression
27,876 Patients Enrolled for Depression
David C Mohr, PhDPrincipal InvestigatorNorthwestern University
6 Previous Clinical Trials
739 Total Patients Enrolled
6 Trials studying Depression
739 Patients Enrolled for Depression

Media Library

Adaptive messaging intervention Clinical Trial Eligibility Overview. Trial Name: NCT04948268 — N/A
Depression Research Study Groups: Non-personalized digital Mental Health intervention with coaching, Active control, Adaptive digital mental health intervention without coaching, Non-personalized digital Mental Health intervention without coaching, Adaptive digital mental health intervention with coaching
Depression Clinical Trial 2023: Adaptive messaging intervention Highlights & Side Effects. Trial Name: NCT04948268 — N/A
Adaptive messaging intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04948268 — N/A
~65 spots leftby Sep 2025
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