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

Primary Purpose

Depressive Symptoms, Anxiety Generalized

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mobile Phone Application
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Depression, Anxiety, Mobile Phone, Cellular Phone, Mobile Application, Mobile Intervention, App, mHealth, eHealth, Technology Assisted, Internet, Cognitive Behavioral Therapy, LGBT, Sexual Minorities, Gay, Bisexual, Same Sex Attraction, Males, Men, Youth, Adolescents, Young Adults

Eligibility Criteria

17 Years - 20 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

App teaching cognitive behavioral skills

Wait-list with referrals

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire-9 (PHQ-9)
Self-report measure of depressive symptoms
GAD-7
Self-report measure of anxiety symptoms

Secondary Outcome Measures

Full Information

First Posted
February 20, 2014
Last Updated
August 14, 2017
Sponsor
Northwestern University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02072252
Brief Title
Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men
Acronym
TODAY!
Official Title
Mobile Phone and Internet-Based Intervention for Vulnerable Youth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The app was not completed in time to conduct a clinical trial on it within the funding grant's award period
Study Start Date
August 14, 2017 (Anticipated)
Primary Completion Date
August 14, 2017 (Anticipated)
Study Completion Date
August 14, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety Generalized
Keywords
Depression, Anxiety, Mobile Phone, Cellular Phone, Mobile Application, Mobile Intervention, App, mHealth, eHealth, Technology Assisted, Internet, Cognitive Behavioral Therapy, LGBT, Sexual Minorities, Gay, Bisexual, Same Sex Attraction, Males, Men, Youth, Adolescents, Young Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
App teaching cognitive behavioral skills
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list with referrals
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Phone Application
Other Intervention Name(s)
TODAY!
Intervention Description
Mobile phone app teaching cognitive behavioral skills
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
Self-report measure of depressive symptoms
Time Frame
post-intervention (10 weeks)
Title
GAD-7
Description
Self-report measure of anxiety symptoms
Time Frame
post-intervention (10 weeks)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle N Burns, Ph.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24311444
Citation
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.
Results Reference
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Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men

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