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

Depressive Symptoms Clinical Trial

— TODAY!  

Official title:

Mobile Phone and Internet-Based Intervention for Vulnerable Youth

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02072252
• Other study ID #: STU00061284
• Secondary ID: K08MH094441
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: February 20, 2014
• Last updated: August 14, 2017
• Start date: August 14, 2017
• Est. completion date: August 14, 2017

Study information

• Verified date: August 2017
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 14, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 17 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Generalized
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Mobile Phone Application
Mobile phone app teaching cognitive behavioral skills

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-9 (PHQ-9)	Self-report measure of depressive symptoms	post-intervention (10 weeks)
Primary	GAD-7	Self-report measure of anxiety symptoms	post-intervention (10 weeks)