Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men



Status:Not yet recruiting
Conditions:Anxiety, Depression, Depression, Major Depression Disorder (MDD), Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:17 - 20
Updated:4/21/2016
Start Date:March 2016
End Date:June 2017
Contact:Michelle N Burns, Ph.D.
Email:mnburns@northwestern.edu
Phone:312-503-8039

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Mobile Phone and Internet-Based Intervention for Vulnerable Youth

The purpose of this study is to determine whether a mobile phone application ("app") for
Major Depression and Generalized Anxiety Disorder 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.

The aim of this study is to conduct a feasibility trial and then 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 feasibility study 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). After the feasibility trial, the investigators will
conduct the small RCT, where outcomes will be monitored pre-, mid-, and post-treatment, as
well as twice over a 10 week follow-up period.

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)

- Has in the past, or currently, regularly used a mobile phone

- Current Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of Major
Depressive Disorder or Generalized Anxiety Disorder as assessed using the
Mini-International Neuropsychiatric Interview, plus 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

- Study staff do not receive the participant's replies to test messages sent using the
mobile phone during a several day "run-in" prior to enrollment

- Plans to begin psychotherapy in the next 10 weeks (this is only an exclusion criteria
for the feasibility trial, not the RCT)
We found this trial at
1
site
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Phone: 312-503-8039
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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mi
from
Chicago, IL
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