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Digital Mental Health Intervention for Depression and Anxiety
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Engagement length
Kessler Psychological Distress Scale
Secondary outcome measures
Generalized Anxiety Disorder-7
Patient Health Questionnaire-9
Other outcome measures
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
1,585 Previous Clinical Trials
917,111 Total Patients Enrolled
66 Trials studying Depression
28,305 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a smartphone.You are not able to communicate effectively in English to participate in the study.I am between 18 and 25 years old, or 19 and 25 if I live in Nebraska.You have severe suicidal thoughts with a plan to harm yourself.I am currently receiving mental health treatment.I plan to seek mental health treatment soon.You have a severe mental illness that would make it unsafe for you to participate. Examples include psychosis or manic episodes.
Research Study Groups:
This trial has the following groups:- Group 1: Non-personalized digital Mental Health intervention with coaching
- Group 2: Active control
- Group 3: Adaptive digital mental health intervention without coaching
- Group 4: Non-personalized digital Mental Health intervention without coaching
- Group 5: Adaptive digital mental health intervention with coaching
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment for this investigation limited to individuals over 20 years old?
"This particular trial is catering to individuals aged between 18 and 25, while there are 239 studies for minors and 1031 trials involving participants over the age of 65."
Answered by AI
What can be expected to be revealed by the results of this scientific investigation?
"This 16-week study will be primarily observing the duration of engagement, with additional secondary outcomes including an 8-item self-report measure assessing generalized anxiety disorder symptom severity (Generalized Anxiety Disorder-7; min. score 0, max.score 21), a 12 item self report measuring health and disability across domains (World Health Organization Disability Assessment Schedule 2.0; min. score 12, max score 60), and finally a 10 item self report exploring openness to seeking treatment for emotional problems as well as value and need in doing so (Attitudes Toward Seeking Professional Psychological Help Scale Short Form; min. Score 0, Max Score 30)."
Answered by AI
Are there still open slots in this clinical investigation?
"Per clinicaltrials.gov, this investigation is no longer accepting participants; the trial was first posted on December 1st 2022 and last updated on June 21st 2022. However, there are over 1400 other trials actively recruiting currently."
Answered by AI
Am I eligible to take part in this clinical trial?
"This mental health research is enrolling 120 young adults who are grappling with suicidal thoughts. The age range for eligibility is 18 to 25; however, due to Nebraska's laws regarding consent, individuals from this state must be 19 or older in order to participate."
Answered by AI
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