- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01678196
Helping Families Help Veterans With PTSD and Alcohol Abuse: An RCT of VA-CRAFT
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Background PTSD and AUDs are highly prevalent psychiatric disorders among combat Veterans that can lead to substantial impairments and disability. Although empirically supported treatments are available, the majority of Veterans suffering PTSD or AUDs do not engage in any mental health care. Data show that encouragement and support by family members play a key role in Veterans' willingness to engage in mental health care. However, many family members may not know how best to help their Veterans engage in mental health care. VA-CRAFT is an innovative adaptation of an empirically supported family training intervention (CRAFT) that has been shown to dramatically increase treatment engagement among substance abusing civilian samples. VA-CRAFT includes Veteran-specific content, a focus on PTSD, SUDs, or both, and also make use of interactive web-technology to increase its efficiency and reach. Pilot research is needed to begin to evaluate the effectiveness of this adaptation of an existing, efficacious intervention, to provide feedback to VA-CRAFT developers for possible modifications to content and delivery, and to inform future studies.
Objectives Specific aims are to: 1) provide pilot data on the effectiveness of VA-CRAFT on Veterans' mental health service utilization; 2) provide pilot data on the effectiveness of VA-CRAFT on family members' wellbeing, personal quality of life, perceived relationship quality with Veteran, and communication about treatment seeking; 3) obtain pilot data to explore possible differences in intervention response between Veterans with AUDs only, PTSD only, or both; and 4) provide information regarding potential changes in content and delivery as well as mediators and moderators of outcome for VA-CRAFT.
Methods This is a randomized controlled trial of VA-CRAFT that will obtain preliminary information on its effectiveness and pilot information to inform future studies. Participants will be drawn from a cohort of Veterans and family members enrolled in the Readiness and Resilience in National Guard Soldiers studies (RINGS; Polusny & Erbes, PIs). Using Veterans' responses to post-deployment RINGS surveys and administrative data, family members of Veterans who screen positive for PTSD or AUDs will be recruited and divided into 1 of 3 subsamples: 1) family of Veterans with AUDs only (anticipated n = 38), 2) family of Veterans with PTSD only (anticipated n = 72), and 3) family of Veterans with both PTSD and AUDs (anticipated n = 74; total anticipated N =184 across the 3 subsamples). Family member participants will complete baseline questionnaires of perceived Veteran PTSD and AUD symptoms, family functioning and communication, and well-being and will be randomly assigned to VA-CRAFT or Control (no treatment) conditions. Those assigned to the VA-CRAFT condition will complete the online VA-CRAFT course. Progress through VA-CRAFT will be monitored and stepped outreach efforts (emails, phone contacts) will be systematically used, as necessary, to promote completion of the intervention. Three months after the baseline assessment, family members and Veterans will complete follow-up questionnaires. Primary outcomes will include: 1) Veteran's mental health service utilization during the 3 months following initiation of VA-CRAFT as assessed by VA administrative data and 2) family member self-reports of wellbeing and quality of life and 3) family and Veteran reports of perceived relationship quality and communication about treatment seeking. Effect sizes will be estimated for each outcome within each subsample of participants (AUD only, PTSD only, and comorbid) and, if patterns are similar within subsamples, for the sample overall. Following the post-intervention questionnaires, qualitative interviews will be conducted with up to 40 family participants to examine possible moderators and mediators of treatment responses and to elicit participant feedback on VA-CRAFT modules and development to inform future VA-CRAFT development.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Minnesota
-
Minneapolis, Minnesota, Vereinigte Staaten, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Family participants:
- must have participated in a Readiness and Resilience in National Guards Soldiers - (RINGS) study and be a spouse, partner, or family member of a Veteran who has also participated in a RINGS study
- report frequent contact with the Veteran
- be paired with a Veteran who has not received mental health services at VA or in the community for the past 3 months and who has screened positive for PTSD or AUDs
- and have regular access to the internet.
Veteran participants:
- must have participated in a RINGS study
- be in significant contact with a spouse/partner/family member who has enrolled in this protocol
- screened positive for PTSD and/or AUD through their responses to a RINGS survey
- and have not received mental health care (based on VA administrative data) or in the community for the past 3 months
Exclusion Criteria:
- Family members (and thus Veterans) will not be eligible for the study if they or their Veteran have reported severe levels of interpersonal violence in their relationship in the past 3 months.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: VA-CRAFT
Family participants complete an on-line training course (VA-CRAFT) over a 3 month period
|
VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders.
12 on-line sessions.
|
Placebo-Komparator: Control
Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
|
Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Veteran Engagement in VA Mental Health Services
Zeitfenster: 3 months after initiation of the intervention
|
Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.
|
3 months after initiation of the intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18
Zeitfenster: 3 months after initiation of the intervention
|
Brief Symptom Inventory - 18 (Derogatis, 1993) is an 18 item measure of general mental health symptoms and distress.
The total score is used, which is the mean of 18 items rated from 0 (not at all) to 4 (extremely) distressing.
Total scores range from 0 (low distress) to 4 (high distress).
|
3 months after initiation of the intervention
|
Family Functioning
Zeitfenster: 3 months after the initiation of the intervention
|
Relationship Happiness Scale.
The RHS is a 9 item scale of general happiness in close relationships.
The total score is reported here, reflecting the mean of the 9 items rated on a scale of 1 (completely unhappy) to 10 (completely happy).
Higher total scores reflect greater relationship happiness.
|
3 months after the initiation of the intervention
|
Caregiver Burden
Zeitfenster: 3 months post-randomization
|
Caregiver Burden Scale (CBS).
The CBS is a 16 items scale assessing caregiver burden.
It has 16 items rated from 1 (not at all) to 5 (extremely) distressed or burdened.
Scores reported are the total scale scores, calculated as the mean of the 16 items, with a range from 1 (low burden) to 5 (high burden).
|
3 months post-randomization
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Christopher R. Erbes, PhD, Minneapolis VA Health Care System, Minneapolis, MN
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Tran T, Kuhn ER, Walser R, Drescher K. The relationship between religiosity, PTSD, and depressive symptoms in veterans in PTSD residential treatment. Journal of psychology and theology. 2012 Oct 1; 40(Winter 2012):313-322.
- Kuhn ER, Landes S. Mental and Behavioral Health Apps for Service Members, Veterans, and Providers. Society for Media Psychology & Technology: The Amplifier. 2013 Apr 1; Spring/Summer(2013):8-10.
- Reger GM, Hoffman J, Riggs D, Rothbaum BO, Ruzek J, Holloway KM, Kuhn E. The "PE coach" smartphone application: an innovative approach to improving implementation, fidelity, and homework adherence during prolonged exposure. Psychol Serv. 2013 Aug;10(3):342-349. doi: 10.1037/a0032774.
- Erbes CR, Stinson R, Kuhn E, Polusny M, Urban J, Hoffman J, Ruzek JI, Stepnowsky C, Thorp SR. Access, utilization, and interest in mHealth applications among veterans receiving outpatient care for PTSD. Mil Med. 2014 Nov;179(11):1218-22. doi: 10.7205/MILMED-D-14-00014.
- Kuhn E, Greene C, Hoffman J, Nguyen T, Wald L, Schmidt J, Ramsey KM, Ruzek J. Preliminary evaluation of PTSD Coach, a smartphone app for post-traumatic stress symptoms. Mil Med. 2014 Jan;179(1):12-8. doi: 10.7205/MILMED-D-13-00271.
- Kuhn E, Eftekhari A, Hoffman JE, Crowley JJ, Ramsey KM, Reger GM, Ruzek JI. Clinician perceptions of using a smartphone app with prolonged exposure therapy. Adm Policy Ment Health. 2014 Nov;41(6):800-7. doi: 10.1007/s10488-013-0532-2.
- Ruzek JI, Eftekhari A, Rosen CS, Crowley JJ, Kuhn E, Foa EB, Hembree EA, Karlin BE. Factors related to clinician attitudes toward prolonged exposure therapy for PTSD. J Trauma Stress. 2014 Aug;27(4):423-9. doi: 10.1002/jts.21945.
- Whealin JM, Kuhn E, Pietrzak RH. Applying behavior change theory to technology promoting veteran mental health care seeking. Psychol Serv. 2014 Nov;11(4):486-94. doi: 10.1037/a0037232.
- Owen JE, Jaworski BK, Kuhn E, Makin-Byrd KN, Ramsey KM, Hoffman JE. mHealth in the Wild: Using Novel Data to Examine the Reach, Use, and Impact of PTSD Coach. JMIR Ment Health. 2015 Mar 25;2(1):e7. doi: 10.2196/mental.3935. eCollection 2015 Jan-Mar.
- Williams EC, Gupta S, Rubinsky AD, Jones-Webb R, Bensley KM, Young JP, Hagedorn H, Gifford E, Harris AH. Racial/Ethnic Differences in the Prevalence of Clinically Recognized Alcohol Use Disorders Among Patients from the U.S. Veterans Health Administration. Alcohol Clin Exp Res. 2016 Feb;40(2):359-66. doi: 10.1111/acer.12950.
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 (Schätzen)
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
- CRE 12-024
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur PTBS
-
Walter Reed National Military Medical CenterUniformed Services University of the Health SciencesUnbekanntUnterschwellige PTSDVereinigte Staaten
-
Massachusetts General HospitalRekrutierungPTSD (Geburtsbezogen)Vereinigte Staaten
-
Insamlingsstiftelsen Wonsa, World of No Sexual...Karolinska InstitutetAbgeschlossenSymptome einer posttraumatischen Belastungsstörung (PTSD)Schweden
-
Groupe Francais d'Epidemiologie PsychiatriqueUnbekanntPTSD Posttraumatisches SyndromFrankreich
-
Henry M. Jackson Foundation for the Advancement...Federal government (congressional allocation)AbgeschlossenPosttraumatische Belastungsstörung (PTSD)Vereinigte Staaten
-
British University In EgyptAbgeschlossenPosttraumatische Belastungsstörung (PTSD)Ägypten
-
Emory UniversityAbgeschlossenPosttraumatische Belastungsstörung (PTSD)
-
NYU Langone HealthYale UniversityBeendetPosttraumatische Belastungsstörung (PTSD)Vereinigte Staaten
-
Tel-Aviv Sourasky Medical CenterBeth Israel Deaconess Medical Center; Tel Aviv UniversityUnbekanntPosttraumatische Belastungsstörung (PTSD)Israel
-
Henry M. Jackson Foundation for the Advancement...United States Department of Defense; University of Washington; RAND; RTI International und andere MitarbeiterAbgeschlossenDepression | Posttraumatische Belastungsstörung (PTSD)Vereinigte Staaten
Klinische Studien zur VA-CRAFT
-
VA Office of Research and DevelopmentMinneapolis Veterans Affairs Medical Center; Corporal Michael J. Crescenz VA...RekrutierungBelastungsstörungen, posttraumatischVereinigte Staaten
-
Mclean HospitalNational Institute on Drug Abuse (NIDA)AbgeschlossenSchizophrenie | Schizoaffektiven Störung | Tabakkonsum | Bipolare Störung | Cannabis | Substanzgebrauch | Substanzgebrauchsstörungen | Psychose | Alkoholkonsumstörung | Psychische Störung | Zigaretten rauchen | Nikotinkonsumstörung | Familie | Marihuana | AlkoholVereinigte Staaten
-
Stanford UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Southern... und andere MitarbeiterRekrutierungAlkohol trinken | Alkoholkonsumstörung | Alkoholmissbrauch | Militärische Familie | Beziehungen, zwischenmenschlichVereinigte Staaten
-
Mclean HospitalNational Institute on Drug Abuse (NIDA)RekrutierungSchizophrenie | Schizoaffektiven Störung | Bipolare Störung | Cannabis | Substanzgebrauch | Substanzgebrauchsstörungen | Psychose | Psychische Störung | Familie | Marihuana | AlkoholVereinigte Staaten
-
The First Affiliated Hospital of Nanchang UniversityNoch keine Rekrutierung
-
University of CincinnatiNational Institute on Drug Abuse (NIDA); MaryhavenUnbekanntHeroinabhängigkeit | Opiatabhängigkeit | DrogenabhängigkeitVereinigte Staaten
-
Medical University of ViennaRekrutierungKohlendioxidÖsterreich
-
Assistance Publique - Hôpitaux de ParisSuspendiertAkuter Myokardinfarkt | Kardiogener SchockFrankreich
-
University of California, DavisBill and Melinda Gates Foundation; Penn State University; Newcastle University; Helen... und andere MitarbeiterAbgeschlossenVitamin-A-StatusPhilippinen
-
Christian SchulzeRekrutierung