Study Stopped
The app was not completed in time to conduct a clinical trial on it within the funding grant's award period
Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men
TODAY!
Mobile Phone and Internet-Based Intervention for Vulnerable Youth
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to determine whether a mobile phone application ("app") for symptoms of depression and anxiety is practical and acceptable to young men who are attracted to men, and whether it reduces their anxiety and depressive symptoms. The investigators will also evaluate whether reductions in symptoms are maintained over a 10 week follow-up period after young men complete the mobile phone intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2017
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
February 20, 2014
CompletedFirst Posted
Study publicly available on registry
February 26, 2014
CompletedStudy Start
First participant enrolled
August 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2017
CompletedAugust 17, 2017
August 1, 2017
Same day
February 20, 2014
August 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient Health Questionnaire-9 (PHQ-9)
Self-report measure of depressive symptoms
post-intervention (10 weeks)
GAD-7
Self-report measure of anxiety symptoms
post-intervention (10 weeks)
Study Arms (2)
App teaching cognitive behavioral skills
EXPERIMENTALApp teaching cognitive behavioral skills. This mobile phone application ("app") teaches cognitive behavioral techniques to help participants manage their mood, for example by providing information, interactive tools and tips, and a mood tracker. A coach will support participants as they use the app via phone calls and email contacts.
Wait-list with referrals
NO INTERVENTION10-week wait-list control condition in which participants will be provided with and encouraged to use mental health referrals to resources in the community. After the 10-week waiting period, control group participants will have the option to receive the mobile phone application and coaching.
Interventions
Mobile phone app teaching cognitive behavioral skills
Eligibility Criteria
You may qualify if:
- Male birth sex and male gender identity
- Reports sexual attraction toward males
- Is between 17-20 years of age
- Is able to speak and read English
- Resides in the Chicago metropolitan area (i.e., Chicago or suburbs of Cook County)
- Currently owns a mobile phone that is compatible with the intervention application, and believes he will be able to keep using this mobile phone for the next 10 weeks
- A score of 10 or more on the Patient Health Questionnaire-9 or 5 or more on the GAD-7
You may not qualify if:
- Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone
- Per self-reported history or the Mini-International Neuropsychiatric Interview, has ever been diagnosed with a psychotic disorder or bipolar disorder, or is currently diagnosed with obsessive compulsive disorder or substance dependence, or has been diagnosed in the past five years with posttraumatic stress disorder, dissociative disorder, or eating disorder; or evidences another condition that indicates this intervention may be insufficient
- Has ever been hospitalized for psychiatric reasons or attempted suicide, or has a score of 4 or more on the Columbia Suicide Severity Rating Scale, or reports non-suicidal self-injury of a nature that suggests this intervention may be insufficient
- Is participating in "Crew 450," "Keep It Up," "My Peeps," or "Q2"
- Reports currently being in Illinois Department of Child and Family Services (DCFS) custody
- Reports currently being in psychotherapy
- Initiation, discontinuation, or adjustment of antidepressant medication in the past 4 weeks
- Less than an 8th grade reading level
- Does not log into the app within 3 days of being sent the link.
- Does not have an email address
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Related Publications (1)
Burns MN, Montague E, Mohr DC. Initial design of culturally informed behavioral intervention technologies: developing an mHealth intervention for young sexual minority men with generalized anxiety disorder and major depression. J Med Internet Res. 2013 Dec 5;15(12):e271. doi: 10.2196/jmir.2826.
PMID: 24311444BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle N Burns, Ph.D.
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 20, 2014
First Posted
February 26, 2014
Study Start
August 14, 2017
Primary Completion
August 14, 2017
Study Completion
August 14, 2017
Last Updated
August 17, 2017
Record last verified: 2017-08