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A Randomized Controlled Trial of Coaching Into Care With VA-CRAFT to Promote Veteran Engagement in PTSD Care

Primary Purpose

Stress Disorders, Post-traumatic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CIC+VA-CRAFT
CIC
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-traumatic focused on measuring Stress Disorders, Post-traumatic, Internet-Based Intervention, Telemedicine, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The target population consists of partners who are in regular contact with a Veteran from any service era who believe that their Veteran is suffering from significant symptoms of PTSD and in need of mental health care.

Inclusion criteria are:

  • reporting being in an intimate relationship (dating, engaged, or married) with a Veteran
  • reporting that their Veteran is not engaged in mental health care and has not been for the past 6 months
  • reporting perceived symptoms of PTSD in their Veteran
  • reporting frequent contact with their Veteran (some verbal or face-to-face contact for 36 of the past 90 days)
  • having regular access to the Internet and a telephone; and 6) being 18 years of age or older

Exclusion Criteria:

  • reporting by the potential participant that they are subject to domestic violence and may not feel safe engaging in CIC+VA-CRAFT activities
  • we will exclude partners reporting severe intimate partner violence on the brief Conflict Tactics Scale 2 Short Form with their Veteran in the past 6 months

    • appropriate referrals for those excluded based on recent intimate partner violence will be provided

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CIC+VA-CRAFT

CIC

Arm Description

Coaching Into Care plus VA-CRAFT consists of four 45-min. telephone coaching calls over 8-12 weeks, delivered by a coach following a manual, while participants are completing the VA-CRAFT for PTSD web-based course.

Coaching Into Care is an existing national VA program that provides telephone consultation and coaching to family members of Veterans with mental health needs who want to help connect them with mental health care by providing referrals, educational information, and a unique coaching service to help callers talk to their Veterans about their decision to seek care.

Outcomes

Primary Outcome Measures

Veteran Mental Health Service Utilization Change
Veteran mental health service initiation as reported by the enrolled partner. This will be operationalized dichotomously (whether any mental health services are initiated) for VA and non-VA services for the 3- and 6-month periods following randomization.
Client Satisfaction Questionnaire (CSQ; Attkisson et al., 1979)
This 8-item measure assesses general client satisfaction at post-treatment stage for the intervention delivered in the study. The Client Satisfaction Questionnaire is a self-report measure with each item score ranging from 1 to 4. The total score is derived from summing all items ranging from 1 to 32, with higher scores reflecting greater program satisfaction.

Secondary Outcome Measures

Montgomery Borgatta Caregiver Burden Scale( Montgomery & Borgatta, 1985)
This 22-item measure assesses the change in the objective burden, subjective stress burden, and subjective demand burden of caregiving over twelve weeks. Final score is the total sum of each item, where each item score ranges from 0 to 4 with the final score ranging from 0 to 88. The total raw score will indicate either little or no caregiver burden (0 to 20), mild to moderate caregiver burden (21 to 40), moderate to severe caregiver burden (41 to 60) or severe caregiver burden (61-88).
World Health Organization - Quality of Life (Brief; WHOQOL; World Health Organization, 1996))
This 26-item self-report measure assesses the change in four domains of quality of life over twelve weeks: physical health, psychological health, social relationships, and environment. Each item score ranges between 1 to 5. To assess each domain, total scores for items measuring that domain are further calculated and transformed into a 0 to 100 scale. Domain scores are in positive direction, where higher scores indicate higher quality of life.
Brief Symptom Inventory (BSI; Derogatis, 2000)
This 18-item self-report measure assesses the change in psychological distress and psychiatric symptoms over twelve weeks. Each item score ranges between 0 to 5, where final score of all items are aggregated and transformed into a t-score for three subscales on the Global Severity Index (GSI): somatization, depression and anxiety. Higher t-score for each subscale on the GSI indicates clinically significant symptoms.
Family Environment Scale (FES; Moos, 1974)
The 20-item self-report measure assesses the change in general familial relationship functioning, with subscales measuring Cohesion and Conflict over twelve weeks. Each item is a 'Yes' or 'No' item with a scoring or 1 and 0, respectively. Subscales are scored by summing scores for items measuring their component subscale, resulting in two subscale scores. The subscale scores are then used to categorize families' social climate.

Full Information

First Posted
August 3, 2020
Last Updated
April 19, 2023
Sponsor
VA Office of Research and Development
Collaborators
Corporal Michael J. Crescenz VA Medical Center, Minneapolis Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04501328
Brief Title
A Randomized Controlled Trial of Coaching Into Care With VA-CRAFT to Promote Veteran Engagement in PTSD Care
Official Title
A Randomized Controlled Trial of Coaching Into Care With VA-CRAFT to Promote Veteran Engagement in PTSD Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Corporal Michael J. Crescenz VA Medical Center, Minneapolis Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 HSR&D-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 CIC+VA-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 CIC+VA-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. Spouse/partners who believe their Veteran needs PTSD treatment will be randomized to CIC+VA-CRAFT or CIC only (i.e., 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 CIC+VA-CRAFT for Veteran mental health service initiation. The investigators hypothesize that spouse/partners in CIC+VA-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 CIC+VA-CRAFT relative to CIC only. The investigators hypothesize that satisfaction with CIC+VA-CRAFT will be non-inferior to satisfaction with the CIC program. Aim 3: Conduct a process evaluation to inform potential future implementation of CIC+VA-CRAFT. Qualitative interviews with spouse/partners, their Veterans, and study and CIC coaches, will be used to inform future implementation of the CIC+VA-CRAFT intervention into the CIC program. Exploratory Aims: Explore potential within-condition improvements and between-condition changes on spouse/partner 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. 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 intervention's rapid dissemination should the trial prove successful.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-traumatic
Keywords
Stress Disorders, Post-traumatic, Internet-Based Intervention, Telemedicine, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Coaching Into Care plus VA-CRAFT consists of four 45-min. telephone coaching calls over 8-12 weeks, delivered by a coach following a manual. Calls focus on supporting and holding the participant accountable for using the VA-CRAFT for PTSD web-based course. This course is based on Community Reinforcement and Family Training (CRAFT) which is intended to help family members of Veterans with PTSD who are resistant to seek treatment for PTSD to initiate care as well as promote the family member's wellbeing and improve their relationship with the Veteran. Calls are designed to: 1) help participants maintain motivation to complete VA-CRAFT lessons in a timely fashion by using reinforcement and motivational techniques; 2) consolidate information and implement skills that they are learning in the course through lesson review, role plays, and problem solving; and, 3) normalize and validate the challenges of having a loved one with PTSD who is reluctant to seek care (i.e., supportive caring).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CIC+VA-CRAFT
Arm Type
Experimental
Arm Description
Coaching Into Care plus VA-CRAFT consists of four 45-min. telephone coaching calls over 8-12 weeks, delivered by a coach following a manual, while participants are completing the VA-CRAFT for PTSD web-based course.
Arm Title
CIC
Arm Type
Active Comparator
Arm Description
Coaching Into Care is an existing national VA program that provides telephone consultation and coaching to family members of Veterans with mental health needs who want to help connect them with mental health care by providing referrals, educational information, and a unique coaching service to help callers talk to their Veterans about their decision to seek care.
Intervention Type
Behavioral
Intervention Name(s)
CIC+VA-CRAFT
Other Intervention Name(s)
Coaching Into Care plus VA-CRAFT
Intervention Description
CIC+VA-CRAFT consists of four 45-min. telephone coaching calls over 8-12 weeks, delivered by a coach following a manual, while participants are completing the VA-CRAFT for PTSD web-based course.
Intervention Type
Behavioral
Intervention Name(s)
CIC
Other Intervention Name(s)
Coaching Into Care
Intervention Description
Coaching Into Care is an existing national VA program that provides telephone consultation and coaching to family members of Veterans with mental health needs who want to help connect them with mental health care by providing referrals, educational information, and a unique coaching service to help callers talk to their Veterans about their decision to seek care.
Primary Outcome Measure Information:
Title
Veteran Mental Health Service Utilization Change
Description
Veteran mental health service initiation as reported by the enrolled partner. This will be operationalized dichotomously (whether any mental health services are initiated) for VA and non-VA services for the 3- and 6-month periods following randomization.
Time Frame
3 and 6 months post-randomization
Title
Client Satisfaction Questionnaire (CSQ; Attkisson et al., 1979)
Description
This 8-item measure assesses general client satisfaction at post-treatment stage for the intervention delivered in the study. The Client Satisfaction Questionnaire is a self-report measure with each item score ranging from 1 to 4. The total score is derived from summing all items ranging from 1 to 32, with higher scores reflecting greater program satisfaction.
Time Frame
3 months post-randomization
Secondary Outcome Measure Information:
Title
Montgomery Borgatta Caregiver Burden Scale( Montgomery & Borgatta, 1985)
Description
This 22-item measure assesses the change in the objective burden, subjective stress burden, and subjective demand burden of caregiving over twelve weeks. Final score is the total sum of each item, where each item score ranges from 0 to 4 with the final score ranging from 0 to 88. The total raw score will indicate either little or no caregiver burden (0 to 20), mild to moderate caregiver burden (21 to 40), moderate to severe caregiver burden (41 to 60) or severe caregiver burden (61-88).
Time Frame
3 and 6 months post-randomization
Title
World Health Organization - Quality of Life (Brief; WHOQOL; World Health Organization, 1996))
Description
This 26-item self-report measure assesses the change in four domains of quality of life over twelve weeks: physical health, psychological health, social relationships, and environment. Each item score ranges between 1 to 5. To assess each domain, total scores for items measuring that domain are further calculated and transformed into a 0 to 100 scale. Domain scores are in positive direction, where higher scores indicate higher quality of life.
Time Frame
3 and 6 months post-randomization
Title
Brief Symptom Inventory (BSI; Derogatis, 2000)
Description
This 18-item self-report measure assesses the change in psychological distress and psychiatric symptoms over twelve weeks. Each item score ranges between 0 to 5, where final score of all items are aggregated and transformed into a t-score for three subscales on the Global Severity Index (GSI): somatization, depression and anxiety. Higher t-score for each subscale on the GSI indicates clinically significant symptoms.
Time Frame
3 and 6 months post-randomization
Title
Family Environment Scale (FES; Moos, 1974)
Description
The 20-item self-report measure assesses the change in general familial relationship functioning, with subscales measuring Cohesion and Conflict over twelve weeks. Each item is a 'Yes' or 'No' item with a scoring or 1 and 0, respectively. Subscales are scored by summing scores for items measuring their component subscale, resulting in two subscale scores. The subscale scores are then used to categorize families' social climate.
Time Frame
3 and 6 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The target population consists of partners who are in regular contact with a Veteran from any service era who believe that their Veteran is suffering from significant symptoms of PTSD and in need of mental health care. Inclusion criteria are: reporting being in an intimate relationship (dating, engaged, or married) with a Veteran reporting that their Veteran is not engaged in mental health care and has not been for the past 6 months reporting perceived symptoms of PTSD in their Veteran reporting frequent contact with their Veteran (some verbal or face-to-face contact for 36 of the past 90 days) having regular access to the Internet and a telephone; and 6) being 18 years of age or older Exclusion Criteria: reporting by the potential participant that they are subject to domestic violence and may not feel safe engaging in CIC+VA-CRAFT activities we will exclude partners reporting severe intimate partner violence on the brief Conflict Tactics Scale 2 Short Form with their Veteran in the past 6 months appropriate referrals for those excluded based on recent intimate partner violence will be provided
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric R Kuhn, PhD
Phone
(650) 493-5000
Ext
23160
Email
Eric.Kuhn@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Mackintosh, PhD
Phone
(650) 493-5000
Ext
26935
Email
margaret.mackintosh@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric R Kuhn, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven L. Sayers, PhD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric R Kuhn, PhD
Phone
650-493-5000
Ext
23160
Email
Eric.Kuhn@va.gov
First Name & Middle Initial & Last Name & Degree
Anastasia M Villafranca
Phone
(650) 493-5000
Ext
66853
Email
Anastasia.Villafranca@va.gov
First Name & Middle Initial & Last Name & Degree
Craig S. Rosen, PhD
First Name & Middle Initial & Last Name & Degree
Eric R Kuhn, PhD
First Name & Middle Initial & Last Name & Degree
Lindsey E. Zimmerman, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Randomized Controlled Trial of Coaching Into Care With VA-CRAFT to Promote Veteran Engagement in PTSD Care

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