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

NCT04501328 | Active Not Recruiting DMC

• 1 other identifier: IIR 19-031
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-traumatic

Keywords

Stress Disorders, Post-traumatic; Internet-Based Intervention; Telemedicine; Veterans

Outcome Measures

Primary Outcomes (2)

• 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.

  3 and 6 months post-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.

  3 months post-randomization

Secondary Outcomes (4)

• Montgomery Borgatta Caregiver Burden Scale( Montgomery & Borgatta, 1985)

  3 and 6 months post-randomization

• World Health Organization - Quality of Life (Brief; WHOQOL; World Health Organization, 1996))

  3 and 6 months post-randomization

• Brief Symptom Inventory (BSI; Derogatis, 2000)

  3 and 6 months post-randomization

• Family Environment Scale (FES; Moos, 1974)

  3 and 6 months post-randomization

Study Arms (2)

CIC+VA-CRAFT

EXPERIMENTAL

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.

Behavioral: CIC+VA-CRAFT

CIC

ACTIVE COMPARATOR

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.

Behavioral: CIC

Interventions

CIC+VA-CRAFT BEHAVIORAL

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.

Also known as: Coaching Into Care plus VA-CRAFT

CIC+VA-CRAFT

CIC BEHAVIORAL

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.

Also known as: Coaching Into Care

CIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The target population consists of partners and first-degree family members 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.
• reporting being in an intimate relationship (dating, engaged, or married) with a Veteran or a first degree family member of 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Corporal Michael J. Crescenz VA Medical Center: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Related Publications (1)

• Kuhn E, Sayers S, Zimmerman L, Mackintosh MA, Owen JE, Rosen CS, Meis LA, Hagedorn HJ, Erbes CR. Promoting mental health treatment initiation of veterans with PTSD using internet-based family training and telephone coaching: Protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Jul;154:107929. doi: 10.1016/j.cct.2025.107929. Epub 2025 May 2.

  PMID: 40320070 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Eric R Kuhn, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

• Steven L. Sayers, PhD

  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)