Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men (TODAY!)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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Recruitment Status : Withdrawn (The app was not completed in time to conduct a clinical trial on it within the funding grant's award period)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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Michelle Burns, 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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Anxiety Generalized Behavioral: Mobile Phone Application Phase 1 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: post-intervention (10 weeks) ]
    Self-report measure of depressive symptoms

  2. GAD-7 [ Time Frame: post-intervention (10 weeks) ]
    Self-report measure of anxiety symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Michelle N Burns, Ph.D. Northwestern University

Publications:
Layout table for additonal information
Responsible Party: Michelle Burns, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02072252     History of Changes
Other Study ID Numbers: STU00061284
K08MH094441 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michelle Burns, Northwestern University:
Mobile Application
Internet
Depression
Anxiety
Mobile Phone
Cellular Phone
Mobile Intervention
App
mHealth
eHealth
Technology Assisted
Cognitive Behavioral Therapy
LGBT
Sexual Minorities
Gay
Bisexual
Same Sex Attraction
Males
Men
Youth
Adolescents
Young Adults

Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Depression
Mental Disorders
Behavioral Symptoms