NCT01678196

Brief Summary

This project begins to evaluate the effectiveness of a web-based family outreach tool that is designed to promote treatment engagement among Veterans with posttraumatic stress disorder (PTSD) or alcohol use disorders (AUDs) but who have not yet engaged in mental health care. The National Center for PTSD has developed an on-line, Veteran-tailored, interactive web tool called VA - Community Reinforcement and Family Training (VA-CRAFT) that trains family members to effectively help their Veterans to engage in treatment for PTSD and/or AUDs. This project will provide preliminary information about VA-CRAFT's effectiveness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 24, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

September 1, 2016

Enrollment Period

1.6 years

First QC Date

August 29, 2012

Results QC Date

January 27, 2016

Last Update Submit

September 14, 2016

Conditions

Keywords

Family MembersCommunity OutreachInternet

Outcome Measures

Primary Outcomes (1)

  • Veteran Engagement in VA Mental Health Services

    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

Secondary Outcomes (3)

  • Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18

    3 months after initiation of the intervention

  • Family Functioning

    3 months after the initiation of the intervention

  • Caregiver Burden

    3 months post-randomization

Study Arms (2)

VA-CRAFT

EXPERIMENTAL

Family participants complete an on-line training course (VA-CRAFT) over a 3 month period

Behavioral: VA-CRAFT

Control

PLACEBO COMPARATOR

Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Other: Control

Interventions

VA-CRAFTBEHAVIORAL

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.

VA-CRAFT
ControlOTHER

Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (10)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAlcoholism

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Results Point of Contact

Title
Christopher Erbes, PhD
Organization
Minneapolis VA Healthcare Service Center

Study Officials

  • Christopher R. Erbes, PhD

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 3, 2012

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Study Completion

April 1, 2016

Last Updated

October 25, 2016

Results First Posted

February 24, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations