230 Participants Needed

CIC + VA-CRAFT for PTSD

MM
ER
Overseen ByEric R Kuhn, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment CIC + VA-CRAFT for PTSD?

The VA-CRAFT program, which is part of the CIC + VA-CRAFT treatment, has been shown to help family members of veterans with PTSD improve their interactions and encourage veterans to start mental health services. Additionally, collaborative care models, which include elements like VA-CRAFT, have been effective in improving PTSD and depression outcomes in veterans.12345

Is the CIC + VA-CRAFT treatment safe for humans?

The available research on VA-CRAFT, a component of the CIC + VA-CRAFT treatment, suggests it is generally well-received and viewed positively by participants, with no specific safety concerns reported in the studies. However, more extensive evaluation is recommended to fully assess its safety and effectiveness.36789

How is the CIC + VA-CRAFT treatment for PTSD different from other treatments?

CIC + VA-CRAFT is unique because it involves family members in the treatment process, teaching them how to support veterans with PTSD and encouraging them to seek mental health services. This approach not only helps veterans but also improves the well-being and relationships of their family members, which is not typically a focus in other PTSD treatments.3691011

What is the purpose of this trial?

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.

Research Team

ER

Eric R Kuhn, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

SL

Steven L. Sayers, PhD

Principal Investigator

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

Eligibility Criteria

This trial is for partners of Veterans who suspect their Veteran has PTSD and needs mental health care. Partners should be in regular contact with the Veteran, not currently receiving mental health treatment, have internet and phone access, and be over 18. Those experiencing domestic violence or severe conflict with the Veteran are excluded.

Inclusion Criteria

Reporting frequent contact with their Veteran (some verbal or face-to-face contact for 36 of the past 90 days).
Reporting being in an intimate relationship (dating, engaged, or married) with a Veteran.
Having regular access to the Internet and a telephone.
See 3 more

Exclusion Criteria

Excluding partners reporting severe intimate partner violence on the brief Conflict Tactics Scale 2 Short Form with their Veteran in the past 6 months.
I will be referred for help if I've recently faced violence from a partner.
I am experiencing domestic violence and may not feel safe participating in certain activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CIC+VA-CRAFT intervention, consisting of four 45-min telephone coaching calls over 8-12 weeks, while completing the VA-CRAFT web-based course

8-12 weeks
4 telephone coaching calls

Follow-up

Participants are monitored for effectiveness and satisfaction of the intervention, with assessments at 3 and 6 months post-randomization

6 months

Treatment Details

Interventions

  • CIC
  • CIC+VA-CRAFT
Trial Overview The study tests a blended intervention combining telephone coaching (CIC) with an online program (VA-CRAFT) designed to help family members encourage Veterans to seek care for PTSD. The effectiveness of this combined approach versus CIC alone in engaging Veterans in mental health services is being evaluated.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: CIC+VA-CRAFTExperimental Treatment1 Intervention
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.
Group II: CICActive Control1 Intervention
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.

CIC is already approved in United States for the following indications:

🇺🇸
Approved in United States as Coaching Into Care for:
  • Support for family members of Veterans with PTSD

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials
77
Recruited
355,000+

Corporal Michael J. Crescenz VA Medical Center

Collaborator

Trials
31
Recruited
9,900+

Findings from Research

The Prolonged Exposure for Primary Care (PE-PC) treatment, developed for veterans with PTSD, has shown efficacy in reducing PTSD symptoms and could serve as a new access point for effective care in primary care settings.
The IMPACT study aims to assess the functional improvements in veterans receiving PE-PC compared to standard treatment, potentially increasing access to high-quality PTSD care for a larger number of veterans.
Improving function through primary care treatment of PTSD: The IMPACT study protocol.Rauch, SAM., Kim, HM., Acierno, R., et al.[2023]
The Royal Air Force Wroughton PTSD Rehabilitation Programme, which included a 12-day structured inpatient course and follow-up sessions, showed a significant improvement in PTSD symptoms, with 85.3% of the 34 participants no longer meeting the criteria for PTSD one year after treatment.
The main therapeutic technique used was psychological debriefing, indicating its potential effectiveness, but further controlled studies are needed to fully assess its value in treating established PTSD.
Incorporating psychological debriefing techniques within a brief group psychotherapy programme for the treatment of post-traumatic stress disorder.Busuttil, W., Turnbull, GJ., Neal, LA., et al.[2019]
The VA-CRAFT website significantly reduced caregiver burden among spouses/partners of veterans with PTSD, indicating it may be a helpful resource for family members, especially those experiencing high initial distress.
However, the program did not significantly increase the initiation of mental health treatment among veterans, suggesting that further improvements are needed to enhance its effectiveness in encouraging veterans to seek help.
A Pilot Trial of Online Training for Family Well-Being and Veteran Treatment Initiation for PTSD.Erbes, CR., Kuhn, E., Polusny, MA., et al.[2021]

References

Improving function through primary care treatment of PTSD: The IMPACT study protocol. [2023]
Incorporating psychological debriefing techniques within a brief group psychotherapy programme for the treatment of post-traumatic stress disorder. [2019]
A Pilot Trial of Online Training for Family Well-Being and Veteran Treatment Initiation for PTSD. [2021]
Predictors of Initiation and Engagement of Cognitive Processing Therapy Among Veterans With PTSD Enrolled in Collaborative Care. [2018]
Posttraumatic stress disorder collaborative care: A quality improvement study in veterans affairs primary care. [2022]
Evaluation of Community Reinforcement and Family Therapy in the UK military community. [2023]
Launching a Competency-Based Training Program in Evidence-Based Treatments for PTSD: Supporting Veteran-Serving Mental Health Providers in Texas. [2021]
Correction to Lehavot et al. (2021). [2021]
Telemental Health Delivery of Skills Training in Affective and Interpersonal Regulation (STAIR) for Rural Women Veterans Who Have Experienced Military Sexual Trauma. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
A randomized trial of an online, coach-assisted self-management PTSD intervention tailored for women veterans. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
The Use of a Brief Family Intervention to Reduce Dropout Among Veterans in Individual Trauma-Focused Treatment: A Randomized Controlled Trial. [2022]
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