Clinical trial NCT03534167: TODAY! A Mobile App Study
Official title: Mobile Phone and Internet-Based Intervention for Vulnerable Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: depression
anxiety
gay
youth
Cognitive Behavior Therapy
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 22
Sex: MALE
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Change in Patient Health Questionnaire (PHQ) 9-items
timeFrame: Assessed at baseline, 5 weeks, 10 weeks and 22 weeks
measure: Change in Generalized Anxiety Disorder (GAD) 7-item Questionnaire
timeFrame: Assessed at baseline, 5 weeks, 10 weeks and 22 weeks
Secondary outcomes:
measure: Usability feedback
timeFrame: Assessed at baseline, 5 weeks, 10 weeks and 22 weeks. Data regarding usage will be generated on the back end
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Diane Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: