TODAY! A Mobile App Study



Status:Recruiting
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:14 - 24
Updated:8/10/2018
Start Date:June 4, 2018
End Date:July 2019
Contact:Rose Diskin, B.A.
Email:rdiskin@luriechildrens.org
Phone:773-796-3012

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Mobile Phone and Internet-Based Intervention for Vulnerable Youth

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.

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.

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.
We found this trial at
1
site
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Phone: 773-796-3012
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
?
mi
from
Chicago, IL
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