Clinical trial NCT01678196: Helping Families Help Veterans With PTSD and Alcohol Abuse: An RCT of VA-CRAFT
Official title: Helping Families Help Veterans With PTSD and Alcohol Abuse: An RCT of VA-CRAFT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Alcohol Abuse
Keywords: Family Members
Community Outreach
Internet
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-09-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Primary outcomes:
measure: Veteran Engagement in VA Mental Health Services
timeFrame: 3 months after initiation of the intervention
Secondary outcomes:
measure: Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18
timeFrame: 3 months after initiation of the intervention
measure: Family Functioning
timeFrame: 3 months after the initiation of the intervention
measure: Caregiver Burden
timeFrame: 3 months post-randomization
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Christopher R. Erbes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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