- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02954146
Mobile Health Application for Family and Behavioral Health Provider Communication
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27705
- Duke University, Department of Psychiatry
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Working Alliance Inventory (Short Form, Therapist)
Zeitfenster: 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
Zeitfenster: 12 weeks
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Number of weekly sessions attended by participants
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12 weeks
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Working Alliance Inventory (Client)
Zeitfenster: 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
Zeitfenster: 12 weeks
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Measures general knowledge about PTSD
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12 weeks
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Zarit Burden Interview
Zeitfenster: 12 weeks
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Measures stress felt by caregivers
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12 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Dimensions of Anger Reactions
Zeitfenster: 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)
Zeitfenster: Past month
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Assessment of PTSD symptoms
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Past month
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Eric Elbogen, PhD, Duke
- Studienstuhl: Greg Barish, PhD, InferLink Corporation
- Studienstuhl: Patricia E Lester, MD, University of California, Los Angeles
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Pro00069014
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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