Depressive SymptomsPhase 1/2TODAY!NCT02072252
Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men
A Phase 1/2 study testing Mobile Phone Application in people with Depressive Symptoms and Anxiety Generalized, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 17 to 20 years, men only
- Conditions the study is for
- Depressive Symptoms, Anxiety Generalized
- What is being tested?
- Mobile Phone Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 14 Aug 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 20 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Mobile Phone and Internet-Based Intervention for Vulnerable Youth
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.
Read the 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.
- Conditions
- Depressive Symptoms, Anxiety Generalized
- Being tested
- Mobile Phone Application
- 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
- Medical subject headings
- Depression, Generalized Anxiety Disorder, Anxiety Disorders, Alzheimer Disease, Homosexuality, Bisexuality, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Phone ApplicationBehavioural
Also called TODAY!
Mobile phone app teaching cognitive behavioral skills
| Study group | Role | What they receive |
|---|---|---|
| App teaching cognitive behavioral skills | Experimental | 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. Receives: Behavioral: Mobile Phone Application |
| Wait-list with referrals | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
Self-report measure of depressive symptoms
Measured: post-intervention (10 weeks)
GAD-7
Self-report measure of anxiety symptoms
Measured: post-intervention (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study start14 Aug 2017 (estimated)
- Primary completion14 Aug 2017 (estimated)
- Study completion14 Aug 2017 (estimated)
Why it stopped: The app was not completed in time to conduct a clinical trial on it within the funding grant's award period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michelle Burns, Northwestern University
- Investigators
- Michelle N Burns, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072252
- Sponsor's protocol ID
- STU00061284
- Other IDs
- K08MH094441
- Acronym
- TODAY!
- Status last verified
- Aug 2017
- First submitted
- 20 Feb 2014
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24311444
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone and Internet-Based Intervention for Vulnerable Youth
- ClinicalTrials.gov ID
- NCT02072252
- Acronym / sponsor ID
- TODAY! / STU00061284
- Conditions
- Depressive Symptoms, Anxiety Generalized
- Keywords
- Depression, Anxiety, Mobile Phone, Cellular Phone, Mobile Application, Mobile Intervention, App, mHealth
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The app was not completed in time to conduct a clinical trial on it within the funding grant's award period
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Aug 2017 (estimated)
- Primary completion
- 14 Aug 2017 (estimated)
- Study completion
- 14 Aug 2017 (estimated)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App teaching cognitive behavioral skills | Experimental | Behavioral: Mobile Phone ApplicationApp 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. |
| Wait-list with referrals | No intervention | –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. |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Phone ApplicationAlso: TODAY!Mobile phone app teaching cognitive behavioral skills | Behavioural | App teaching cognitive behavioral skills |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Background: PubMed 24311444Burns 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle N Burns, Ph.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mobile Phone Application in people with Depressive Symptoms and Anxiety Generalized, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: post-intervention (10 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02072252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.