- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02954146
Mobile Health Application for Family and Behavioral Health Provider Communication
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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North Carolina
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Durham, North Carolina, Förenta staterna, 27705
- Duke University, Department of Psychiatry
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
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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Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Working Alliance Inventory (Short Form, Therapist)
Tidsram: 12 weeks
|
Documents perspectives of therapist-client relationship
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12 weeks
|
Participant Treatment Participation
Tidsram: 12 weeks
|
Number of weekly sessions attended by participants
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12 weeks
|
Working Alliance Inventory (Client)
Tidsram: 12 weeks
|
Documents perspectives of therapist-client relationship
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12 weeks
|
PTSD Knowledge Scale
Tidsram: 12 weeks
|
Measures general knowledge about PTSD
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12 weeks
|
Zarit Burden Interview
Tidsram: 12 weeks
|
Measures stress felt by caregivers
|
12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Dimensions of Anger Reactions
Tidsram: 12 weeks
|
Measure of anger disposition towards others
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12 weeks
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Clinician-Administered PTSD Scale for DSM5 (CAPS 5)
Tidsram: Past month
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Assessment of PTSD symptoms
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Past month
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Eric Elbogen, PhD, Duke
- Studiestol: Greg Barish, PhD, InferLink Corporation
- Studiestol: Patricia E Lester, MD, University of California, Los Angeles
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00069014
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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