Clinical trial NCT02072252: Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men
Official title: Mobile Phone and Internet-Based Intervention for Vulnerable Youth
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Depressive Symptoms
Anxiety Generalized
Keywords: Depression
Anxiety
Mobile Phone
Cellular Phone
Mobile Application
Mobile Intervention
App
mHealth
eHealth
Technology Assisted
Internet
Cognitive Behavioral Therapy
LGBT
Sexual Minorities
Gay
Bisexual
Same Sex Attraction
Males
Men
Youth
Adolescents
Young Adults
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-02-26
Enrollment: 0
Sex: MALE
Minimum age (years): 17
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The aim of this study is to conduct a small randomized controlled trial (RCT) for a 10-week, culturally tailored mobile phone intervention that uses principles of cognitive behavioral therapy (CBT) to reduce anxiety and depression among young men who are sexually attracted to other males.

The primary purpose of the RCT is to collect feedback about the intervention from the participants. This feedback, along with usage data on which features are used more or less often by the participants, and how the features are used, will be evaluated to make improvements to the intervention. The investigators will also assess clinical outcomes (such as anxiety and depressive symptoms). Outcomes will be monitored pre-, mid-, and post-treatment, as well as twice over a 10 week follow-up period.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: post-intervention (10 weeks)
measure: GAD-7
timeFrame: post-intervention (10 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Michelle N Burns, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.