Helping Families Help Veterans With PTSD and Alcohol Abuse: An RCT of VA-CRAFT

NCT ID: NCT01678196

Last Updated: 2016-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-04-30

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.

Detailed Description

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.

Conditions

PTSD; Alcohol Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

VA-CRAFT

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

Group Type: EXPERIMENTAL

VA-CRAFT

Intervention Type: BEHAVIORAL

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.

Control

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

VA-CRAFT

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.

Intervention Type: BEHAVIORAL

Control

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher R. Erbes, PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Health Care System, Minneapolis, MN

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: 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.

Reference Type: 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.

Reference Type: RESULT

PMID: 23937084 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25373044 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24402979 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24398700 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25158635 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25384001 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26543913 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26842254 (View on PubMed)

Other Identifiers

CRE 12-024

Identifier Type: -

Identifier Source: org_study_id