Loading clinical trials...

TODAY! A Mobile App Study | Clinical Trials | Clareo Health

COMPLETEDNA

TODAY! A Mobile App Study

Mobile Phone and Internet-Based Intervention for Vulnerable Youth

NCT03534167•Ann & Robert H Lurie Children's Hospital of Chicago

Summary

The aim of this study is to conduct a small randomized controlled trial (RCT) for a 10-week mobile phone intervention using principles of Cognitive Behavior Therapy to target general and minority stressors and treat anxiety and depression in young men romantically/sexually attracted to men.

Detailed Description

Investigators will conduct a double-arm RCT to develop the infrastructure and collection of data needed to power a larger RCT (e.g., rates of consent, retention rates). Clinical outcomes will be assessed for the purpose of detecting unexpected deterioration. Investigators will also collect usability feedback regarding the intervention which may be used to refine the treatment. Usage data will be used to identify under-used lessons and tools and improve their usefulness/appeal. Compliance with assessments will be monitored and used to improve retention protocols.

Eligibility

Age

14 - 24 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Were assigned male at birth and identify as a man
•2. Report romantic/sexual attraction to men;
•3. Ages 14-24 years;
•4. Resides in the Chicago metro area (i.e., Chicago or suburbs of Cook County)
•5. Presents with clinically significant depressive or anxiety symptoms, per a 10+ on the PHQ-9 or 5+ on the GAD-7
•6. Currently owns a mobile phone that is compatible with the intervention application, and believes they will be able to keep using this mobile phone for the next 10 weeks
•7. Fluent in English.

Exclusion Criteria

•1. Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone.
•2. Per self-reported history or the Mini-International Neuropsychiatric Interview (MINI) 7 (Adult version for participants ages 17-24 years and Kid version for ages 14-16 years), has ever been diagnosed with a psychotic disorder or bipolar disorder, or is currently diagnosed with obsessive compulsive disorder, or has been diagnosed in the past two years with posttraumatic stress disorder, dissociative disorder, or eating disorder; or evidences another condition that indicates this intervention may be insufficient to meet the youth's needs. If substance abuse disorder is currently present, PI or designated individual will use clinical judgement to determine whether severity/impairment related to substance use indicates this intervention may be insufficient to meet the youth's needs.
•3. Has been hospitalized for psychiatric reasons or has attempted suicide in the last year, or has a score of 4 or more (i.e., "high" to "severe" suicidality) on the Columbia Suicide Severity Rating Scale, or reports non-suicidal self-injury of a nature that suggests this intervention may be insufficient to meet the youth's needs.
•4. Is concurrently participating in another behavioral intervention research study
•5. Reports currently being in DCFS custody and under 21.
•6. Reports currently being in psychotherapy.
•7. Initiation, discontinuation, or adjustment of antidepressant medication in the past 4 weeks. Individuals excluded solely for this reason will be allowed to retake the baseline assessments (and be compensated accordingly) to determine eligibility after they have been on a stable antidepressant regimen for 4 weeks, if the study is still enrolling at that time.
•8. Less than an 8th grade reading level.
•9. Does not have an email address and does not obtain one within 1 week of the telephone screening.

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

June 4, 2018

Primary Completion Date

June 30, 2022

Completion Date

June 30, 2022

Last Updated

March 3, 2023

Enrollment

ACTUAL participants

Conditions

Depression, Anxiety

Interventions

TODAY! App and Coaching

BEHAVIORAL

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

NCT05837104

Bipolar I DisorderDepression, Anxiety+1 more

View study

RECRUITINGNA

Promoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda

NCT06087159

Mental Health LiteracyDepression, Anxiety

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

TODAY! A Mobile App Study

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

Promoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda

Observations of a Brief Online Psychological Intervention Among People Seeking Online Mental Health Services

An Internet-based Self-help Intervention to Improve Common Mental Health Problems Among Medical Professionals

Internet-Delivered Cognitive Behaviour Therapy for Public Safety Personnel

Prevalence of Mental Health Issues in Endurance Athletes.