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

Phase 1

Withdrawn

• Conditions: Depressive Symptoms; Anxiety Generalized
• Interventions: Behavioral: Mobile Phone Application

• Registration Number: NCT02072252
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-26
• Status Verified: 2017-08
• Study Start: 2017-08-14
• Primary Completion: 2017-08-14
• Study Completion: 2017-08-14
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App teaching cognitive behavioral skills	Mobile Phone Application	App teaching cognitive behavioral skills. This mobile phone application ("app") teaches cognitive behavioral techniques to help participants manage their mood, for example by providing information, interactive tools and tips, and a mood tracker. A coach will support participants as they use the app via phone calls and email contacts.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9)	post-intervention (10 weeks)	Self-report measure of depressive symptoms
GAD-7	post-intervention (10 weeks)	Self-report measure of anxiety symptoms

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States