- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02954146
Mobile Health Application for Family and Behavioral Health Provider Communication
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Purpose: we will examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD.
Participants: (N=100) 50 veterans who have served in the military since October 2001 and have PTSD with anger problems; and 50 collateral family members/close friends above the age of 18.
Procedures (methods): All Veterans with PTSD will receive a 12 session standard CBT for anger. Veterans in the intervention group will additionally receive instructions for using SupportTeam with a family member or friend that will provide data for the CBT clinician. Veterans in the control group will receive the CBT sessions, but will not receive the SupportTeam mobile application.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Duke University, Department of Psychiatry
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
For Veteran:
- Age 18 or older
- Served in a branch of the US military since October, 2001
- Meets DSM-5 criteria for current PTSD as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5);
- Reports at least one episode of anger or irritability in the past week;
- Has and regularly uses an iOS (iPhone 5s or higher with iOS 8 or higher) or Android (with 4G network and Android 4.1 or higher) smartphone with a data plan;
- Has a family member or friend who also has and uses a smartphone with a data plan and agrees to participate in the study.
- Is able and willing to attend 12 weekly sessions at Duke Psychiatry offices within normal business hours (M-F 8:00-5:00)
For Collateral:
- 18 years old or older
- Has and regularly uses an iOS (iPhone 5s or higher with iOS 8 or higher) or Android (with 4G network and Android 4.1 or higher) smartphone with a data plan;
- Has a family member or friend who meets the veteran inclusion criteria and agrees to participate in the study.
Exclusion Criteria, Veteran:
- Is currently participating in, or is scheduled to participate in a manualized psychosocial treatment.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: CBT only
Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT only) sessions for anger management.
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Connectd is a mobile application that collects and automatically analyzes input from patients with PTSD/TBI, as well as their families, for clinician review.
The app will aggregate patient and family input on current issues, relationship stressors, and situational stressors to better focus (personalize) treatment as well as to more efficiently and accurately understand key factors and root causes.
In addition, the app provides informational resources for veterans and family regarding treatment options and mental health supports.
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Eksperimentell: CBT + Connectd mobile health app
Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT) sessions for anger management.
In addition, veterans in this group will also receive instructions for using Connectd mobile health app with a family member or friend that will provide data for the CBT clinician.
|
Connectd is a mobile application that collects and automatically analyzes input from patients with PTSD/TBI, as well as their families, for clinician review.
The app will aggregate patient and family input on current issues, relationship stressors, and situational stressors to better focus (personalize) treatment as well as to more efficiently and accurately understand key factors and root causes.
In addition, the app provides informational resources for veterans and family regarding treatment options and mental health supports.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Working Alliance Inventory (Short Form, Therapist)
Tidsramme: 12 weeks
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Documents perspectives of therapist-client relationship
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12 weeks
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Participant Treatment Participation
Tidsramme: 12 weeks
|
Number of weekly sessions attended by participants
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12 weeks
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Working Alliance Inventory (Client)
Tidsramme: 12 weeks
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Documents perspectives of therapist-client relationship
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12 weeks
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PTSD Knowledge Scale
Tidsramme: 12 weeks
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Measures general knowledge about PTSD
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12 weeks
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Zarit Burden Interview
Tidsramme: 12 weeks
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Measures stress felt by caregivers
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12 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Dimensions of Anger Reactions
Tidsramme: 12 weeks
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Measure of anger disposition towards others
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12 weeks
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Clinician-Administered PTSD Scale for DSM5 (CAPS 5)
Tidsramme: Past month
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Assessment of PTSD symptoms
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Past month
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Eric Elbogen, PhD, Duke
- Studiestol: Greg Barish, PhD, InferLink Corporation
- Studiestol: Patricia E Lester, MD, University of California, Los Angeles
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00069014
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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