An interventional study of VA-CRAFT and Control in PTSD and Alcohol Abuse, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-25.
Sponsored by VA Office of Research and Development · Not applicable and Interventional
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.
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 66 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Family participants:
Veteran participants:
Exclusion Criteria:
Family participants complete an on-line training course (VA-CRAFT) over a 3 month period
Behavioral: VA-CRAFT
Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Other: Control
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.
Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
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.
Time frame: 3 months after initiation of the intervention
Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18
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).
Time frame: 3 months after initiation of the intervention
Family Functioning
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.
Time frame: 3 months after the initiation of the intervention
Caregiver Burden
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).
Time frame: 3 months post-randomization
Participants were partners of Veterans who had screened positive for PTSD or alcohol use disorders in prior surveys with the study team. Of 287 identified eligible partners, 190 were successfully reached and 66 consented to be in the study.
| Milestone | VA-CRAFT | Control |
|---|---|---|
| Started | 34 | 32 |
| Completed | 34 | 32 |
| Not completed | 0 | 0 |
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.
| participants | VA-CRAFT | Control |
|---|---|---|
| Veteran Engagement in VA Mental Health Services | 4 | 4 |
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).
| units on a scale | VA-CRAFT | Control |
|---|---|---|
| Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18 | 0.46 ± 0.52 | 0.58 ± 0.59 |
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.
| units on a scale | VA-CRAFT | Control |
|---|---|---|
| Family Functioning | 5.92 ± 1.78 | 5.75 ± 2.36 |
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).
| units on a scale | VA-CRAFT | Control |
|---|---|---|
| Caregiver Burden | 1.56 ± 0.49 | 1.84 ± 0.88 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VA-CRAFT | — | 0/34 (0%) | 0/34 (0%) |
| Control | — | 0/32 (0%) | 0/32 (0%) |
| Age, Categorical(Participants) | VA-CRAFT | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 34 | 32 | 66 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | VA-CRAFT | Control | Total |
|---|---|---|---|
| Female | 34 | 32 | 66 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | VA-CRAFT | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 21 | 21 | 42 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 13 | 10 | 23 |
| Region of Enrollment(participants) | VA-CRAFT | Control | Total |
|---|---|---|---|
| United States | 34 | 32 | 66 |
Plan to share: No
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