- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02072252
Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men (TODAY!)
Mobile Phone and Internet-Based Intervention for Vulnerable Youth
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60611
- Northwestern University Feinberg School of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Mobile phone app teaching cognitive behavioral skills
Andre navn:
|
Ingen inngripen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: post-intervention (10 weeks)
|
Self-report measure of depressive symptoms
|
post-intervention (10 weeks)
|
GAD-7
Tidsramme: post-intervention (10 weeks)
|
Self-report measure of anxiety symptoms
|
post-intervention (10 weeks)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michelle N Burns, Ph.D., Northwestern University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STU00061284
- K08MH094441 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Depressive symptomer
-
China Academy of Chinese Medical SciencesUkjentDepressiv lidelse | Depresjon | Depressivt symptomKina
-
MetroHealth Medical CenterFullførtDepresjon | Hemodialyse-indusert symptomForente stater
-
Trakya UniversityFullførtDysmenoré | Mestringsatferd | Musikk | Tegning | Symptom, depressiv | Dysmenoré SymptomTyrkia
-
Hospital de Sant PauInstituto de Salud Carlos IIIFullførtMajor depressiv lidelse | Kognitivt symptomSpania
-
University Medical Center GroningenMartini Hospital GroningenFullført
-
Fundación SenefroBaxter Healthcare CorporationUkjentHemodialyse-indusert symptomSpania
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityHar ikke rekruttert ennåUreteral stent-relatert symptom
-
National Taiwan University HospitalFullførtHemodialysekomplikasjon | Hemodialyse-indusert symptomTaiwan
-
Queen's University, BelfastFullførtSymptom på inntrengingStorbritannia
-
Benha UniversityNew Jeddah Clinic HospitalFullførtHemodialyse-indusert symptom
Kliniske studier på Mobile Phone Application
-
National University Hospital, SingaporeFullførtPeriodontitt | Gingivitt | Plakett, tannlegeSingapore
-
Pakistan Institute of Living and LearningHar ikke rekruttert ennåUtforskende randomisert kontrollert utprøving av en kunstig intelligens-selvskadeapplikasjon (AISHA)Selvmord | SelvskadingPakistan
-
Medical University of South CarolinaFullført
-
Emory UniversityGeorgia Institute of TechnologyFullførtSelvmord, selvmordstankerForente stater
-
Sülayman YAMANFullførtTilgang til hemodialyseTyrkia
-
Dr. Praveen B.HNathajirao G. Halgekar Institute of Dental Sciences & Research centre...Fullført
-
Mayo ClinicRekrutteringHjerteinfarktForente stater
-
Nantes University HospitalAktiv, ikke rekrutterende
-
University of NebraskaFullførtFriske FrivilligeForente stater
-
Children's Hospital Medical Center, CincinnatiFullførtUlcerøs kolitt, pediatriskForente stater