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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Non-personalized digital Mental Health intervention without coachingExperimental Treatment1 Intervention

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

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

Adaptive messaging intervention

2023

N/A

~120

Non-personalized messaging intervention

2023

N/A

~120