Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501328
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2020-08-03
Brief Title:
A Randomized Controlled Trial of Coaching Into Care With VA-CRAFT to Promote Veteran Engagement in PTSD Care
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Randomized Controlled Trial of Coaching Into Care With VA-CRAFT to Promote Veteran Engagement in PTSD Care
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Posttraumatic stress disorder PTSD afflicts many war Veterans but often they are reluctant to seek help despite availability of effective treatments Family members are key sources of support who can help encourage such Veterans to initiate mental health services Toward that goal VA provides telephone coaching to family members through its Coaching Into Care CIC program to help get their Veterans into care While CIC enjoys high caller satisfaction it has shown only modest success getting Veterans into care Blended interventions that include professional support and technology-based interventions offer promise for improving effectiveness of services Therefore this study tests an intervention that blends CIC calls with a web program called VA Community Reinforcement and Family Training VA-CRAFT VA-CRAFT is a translation of an empirically-validated model intended to help Veterans by training their family members to effectively promote care-seeking If successful this approach will support families and help more Veterans receive needed mental health care for PTSD
Detailed Description:
Posttraumatic Stress Disorder PTSD is a highly prevalent potentially debilitating condition afflicting many war Veterans While efficacious treatments are available most individuals with PTSD do not receive any mental health care VA faces an ongoing challenge of engaging Veterans with PTSD in effective services Recognizing the powerful influence of families on Veteran wellbeing VA has called for increased involvement of family members in the care of Veterans with PTSD In response VA has created a national telephone-based support service called Coaching Into Care CIC to work with family members of Veterans with mental health problems who are reluctant to seek treatment Program evaluation data show that CIC is highly valued by callers but that only about 25 of callers with Veterans not already in care report that their Veteran sought care over the next six months The proposed study is a test of an innovative approach to improve outcomes by blending coaching calls with a web-based program called VA Community Reinforcement and Family Training VA-CRAFT VA-CRAFT is a translation of an empirically-validated model intended to help Veterans by training and supporting their family members to better care for themselves more effectively manage their relationships and have effective care-seeking conversations with their Veterans
Preliminary work suggests that VA-CRAFT may be a powerful adjunct for CIC services In a prior HSRD-funded pilot the investigators team found that family members who completed the relatively brief VA-CRAFT course alone without any coaching had greater decreases in caregiver burden than wait-list controls However qualitative interviews also suggested that participants often did not raise the issue of treatment with their Veteran loved one due to not believing such a conversation would be successful The investigators developed CICVA-CRAFT with the goal of capitalizing on the strengths of both approaches CIC and VA-CRAFT and increasing family members motivation perceived ability to have treatment-seeking conversations with the Veteran and success at engaging their Veterans in care Initial findings from a second NC-PTSD-funded pilot suggest that this brief blended intervention is feasible acceptable and potentially more effective than CIC alone in enhancing Veteran mental health treatment initiation
Primary Objective The primary objective is to investigate the effectiveness of CICVA-CRAFT in improving Veteran treatment initiation above CIC only without compromising the high caller satisfaction of the CIC program To accomplish this the investigators will use a two-group randomized controlled trial Spousepartners who believe their Veteran needs PTSD treatment will be randomized to CICVA-CRAFT or CIC only ie TAU Assessments will occur at baseline post-treatment month 3 and follow-up month 6 To maximize generalizability of findings to the intended population recruitment will use targeted social media advertising and referrals from the existing CIC program Specific aims are
Aim 1 Determine the effectiveness of CICVA-CRAFT for Veteran mental health service initiation The investigators hypothesize that spousepartners in CICVA-CRAFT will report higher rates of mental health service initiation for their Veterans than will participants in the CIC only condition
Aim 2 Investigate caller satisfaction with CICVA-CRAFT relative to CIC only The investigators hypothesize that satisfaction with CICVA-CRAFT will be non-inferior to satisfaction with the CIC program
Aim 3 Conduct a process evaluation to inform potential future implementation of CICVA-CRAFT Qualitative interviews with spousepartners their Veterans and study and CIC coaches will be used to inform future implementation of the CICVA-CRAFT intervention into the CIC program
Exploratory Aims
1 Explore potential within-condition improvements and between-condition changes on spousepartner and family outcomes The investigators will test for these effects on measures of caregiver burden psychological distress quality of life and family conflict and cohesion
2 Explore potential intervention mediators and moderators of Veteran mental health treatment initiation The investigators will explore if self-efficacy outcome expectancy and treatment conversations mediate the effect of the intervention on mental health treatment initiation Demographic variables perceived Veteran symptomatology and partner symptomatology will be explored as moderators of the effect of the intervention
The long-term goal of this research is to establish an efficacious efficient scalable and satisfying family outreach intervention that will significantly increase mental health service initiation among a high priority Veteran population while addressing the needs of their primary supporters their family members This proposal has been developed in collaboration with the existing VA CIC and VA-CRAFT programs and involves the leadership of these programs to facilitate the blended interventions rapid dissemination should the trial prove successful
Preliminary work suggests that VA-CRAFT may be a powerful adjunct for CIC services In a prior HSRD-funded pilot the investigators team found that family members who completed the relatively brief VA-CRAFT course alone without any coaching had greater decreases in caregiver burden than wait-list controls However qualitative interviews also suggested that participants often did not raise the issue of treatment with their Veteran loved one due to not believing such a conversation would be successful The investigators developed CICVA-CRAFT with the goal of capitalizing on the strengths of both approaches CIC and VA-CRAFT and increasing family members motivation perceived ability to have treatment-seeking conversations with the Veteran and success at engaging their Veterans in care Initial findings from a second NC-PTSD-funded pilot suggest that this brief blended intervention is feasible acceptable and potentially more effective than CIC alone in enhancing Veteran mental health treatment initiation
Primary Objective The primary objective is to investigate the effectiveness of CICVA-CRAFT in improving Veteran treatment initiation above CIC only without compromising the high caller satisfaction of the CIC program To accomplish this the investigators will use a two-group randomized controlled trial Spousepartners who believe their Veteran needs PTSD treatment will be randomized to CICVA-CRAFT or CIC only ie TAU Assessments will occur at baseline post-treatment month 3 and follow-up month 6 To maximize generalizability of findings to the intended population recruitment will use targeted social media advertising and referrals from the existing CIC program Specific aims are
Aim 1 Determine the effectiveness of CICVA-CRAFT for Veteran mental health service initiation The investigators hypothesize that spousepartners in CICVA-CRAFT will report higher rates of mental health service initiation for their Veterans than will participants in the CIC only condition
Aim 2 Investigate caller satisfaction with CICVA-CRAFT relative to CIC only The investigators hypothesize that satisfaction with CICVA-CRAFT will be non-inferior to satisfaction with the CIC program
Aim 3 Conduct a process evaluation to inform potential future implementation of CICVA-CRAFT Qualitative interviews with spousepartners their Veterans and study and CIC coaches will be used to inform future implementation of the CICVA-CRAFT intervention into the CIC program
Exploratory Aims
1 Explore potential within-condition improvements and between-condition changes on spousepartner and family outcomes The investigators will test for these effects on measures of caregiver burden psychological distress quality of life and family conflict and cohesion
2 Explore potential intervention mediators and moderators of Veteran mental health treatment initiation The investigators will explore if self-efficacy outcome expectancy and treatment conversations mediate the effect of the intervention on mental health treatment initiation Demographic variables perceived Veteran symptomatology and partner symptomatology will be explored as moderators of the effect of the intervention
The long-term goal of this research is to establish an efficacious efficient scalable and satisfying family outreach intervention that will significantly increase mental health service initiation among a high priority Veteran population while addressing the needs of their primary supporters their family members This proposal has been developed in collaboration with the existing VA CIC and VA-CRAFT programs and involves the leadership of these programs to facilitate the blended interventions rapid dissemination should the trial prove successful
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None