Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men (TODAY!)
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|ClinicalTrials.gov Identifier: NCT02072252|
Recruitment Status : Withdrawn (The app was not completed in time to conduct a clinical trial on it within the funding grant's award period)
First Posted : February 26, 2014
Last Update Posted : August 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms Anxiety Generalized||Behavioral: Mobile Phone Application||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Mobile Phone and Internet-Based Intervention for Vulnerable Youth|
|Estimated Study Start Date :||August 14, 2017|
|Estimated Primary Completion Date :||August 14, 2017|
|Estimated Study Completion Date :||August 14, 2017|
Experimental: App teaching cognitive behavioral skills
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.
Behavioral: Mobile Phone Application
Mobile phone app teaching cognitive behavioral skills
Other Name: TODAY!
No Intervention: Wait-list with referrals
10-week wait-list control condition in which participants will be provided with and encouraged to use mental health referrals to resources in the community. After the 10-week waiting period, control group participants will have the option to receive the mobile phone application and coaching.
- Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: post-intervention (10 weeks) ]Self-report measure of depressive symptoms
- GAD-7 [ Time Frame: post-intervention (10 weeks) ]Self-report measure of anxiety symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072252
|United States, Illinois|
|Northwestern University Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Michelle N Burns, Ph.D.||Northwestern University|