CIC + VA-CRAFT for PTSD

Overseen By Eric R Kuhn, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Domestic violence, Severe intimate partner violence

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Veterans with PTSD (post-traumatic stress disorder) who hesitate to seek mental health care. It combines a phone coaching program, Coaching Into Care (CIC), with an online course, VA-CRAFT, to encourage Veterans to seek necessary help. The study aims to determine if this blended approach can better support families and motivate Veterans to receive care. Partners or close family members of Veterans who are not currently receiving mental health care and exhibit PTSD symptoms may be suitable participants if they have regular contact with the Veteran and access to the internet and phone. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in supporting Veterans and their families.

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 prior data suggests that this intervention is safe for Veterans with PTSD?

Research has shown that both the CIC and CIC+VA-CRAFT treatments are easy for participants to handle. Participants highly appreciate the Coaching Into Care (CIC) program. Although it doesn't always lead Veterans to seek care, people generally have a positive experience with it.

The VA-CRAFT program, combined with CIC in the CIC+VA-CRAFT treatment, has shown encouraging results. It helps family members support Veterans more effectively, improving their interactions. Previous studies have found this combined treatment practical and well-received.

Both treatments have been linked to reductions in PTSD symptoms over time, indicating they are safe and beneficial for participants. Overall, people report satisfaction with the programs, and no major negative effects have been observed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CIC + VA-CRAFT approach for PTSD because it combines personalized coaching with an online course, offering a unique support system for veterans and their families. Unlike standard treatments like cognitive behavioral therapy or medication, this method provides four structured phone coaching sessions over 8–12 weeks, which are designed to enhance understanding and encourage engagement with mental health care. This accessibility and the personalized nature of the coaching aim to bridge the gap between veterans and effective mental health care, potentially making it easier for them to seek and stick with treatment.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that the Coaching Into Care (CIC) program, which participants in this trial may receive, helps veterans with PTSD engage more in mental health care. Studies have found that it significantly reduces PTSD and depression symptoms. Another treatment arm in this trial combines CIC with the VA Community Reinforcement and Family Training (VA-CRAFT). Early results suggest this combination can further assist veterans in starting treatment. VA-CRAFT is an online program that teaches family members how to support veterans in seeking care. By training family members, this combined approach can improve communication and encourage veterans to begin mental health treatment. Overall, these programs aim to help more veterans receive the care they need. ^{3 6 7 8 9}

Who Is on the Research Team?

Steven L. Sayers, PhD

Principal Investigator

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

Eric R Kuhn, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: CIC+VA-CRAFT Experimental Treatment 1 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: CIC Active Control 1 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The study compared an 8-week online, coach-assisted cognitive behavioral intervention (DESTRESS-WV) for women veterans with PTSD to a phone monitoring support group, involving 102 participants. Both treatments led to significant reductions in PTSD symptoms over time, indicating their efficacy.

While more participants completed the phone monitoring (96% vs. 76% for DESTRESS-WV), those in the DESTRESS-WV group reported higher treatment satisfaction and showed greater improvement in PTSD symptoms at the 3-month follow-up, particularly among those with higher baseline symptom severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correction to Lehavot et al. (2021). [2021]

The pilot study demonstrated that the STAIR program, delivered via video teleconferencing, is feasible and well-accepted by women veterans in rural areas who have experienced military sexual trauma, with high participant satisfaction reported.

Participants showed significant improvements in various areas, including social functioning and symptoms of PTSD, depression, and emotion regulation, indicating the initial efficacy of the STAIR program with effect sizes ranging from Hedge's g = 1.41 to 2.35.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemental Health Delivery of Skills Training in Affective and Interpersonal Regulation (STAIR) for Rural Women Veterans Who Have Experienced Military Sexual Trauma. Weiss, BJ., Azevedo, K., Webb, K., et al.[2019]

A modified collaborative care program for PTSD was successfully implemented in VA primary care, with 239 patients referred and nearly 185 enrolling over a period from November 2012 to March 2017.

Among those who participated, over half (53.4%) showed significant improvement in depression symptoms, and 42.2% reported significant improvement in PTSD symptoms, indicating the program's potential effectiveness in treating these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder collaborative care: A quality improvement study in veterans affairs primary care. Chen, JA., Jakupcak, M., McCann, R., et al.[2022]

The study involved 102 women Veterans with PTSD, comparing an 8-week online cognitive behavioral intervention (DESTRESS-WV) to phone monitoring, and found that both treatments significantly reduced PTSD symptoms over time.

While DESTRESS-WV had lower completion rates (76% vs. 96% for phone monitoring), it resulted in greater symptom improvement for those with higher baseline PTSD severity, suggesting it may be particularly beneficial for women Veterans who can engage with the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of an online, coach-assisted self-management PTSD intervention tailored for women veterans. Lehavot, K., Millard, SP., Thomas, RM., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving function through primary care treatment of PTSD: The IMPACT study protocol. Rauch, SAM., Kim, HM., Acierno, R., et al.[2023]

Rural veterans with PTSD who participated in a telemedicine-based collaborative care intervention showed higher rates of initiating and engaging in cognitive processing therapy (CPT) compared to those receiving usual care, indicating the effectiveness of this approach.

However, veterans with more severe PTSD symptoms and comorbid major depression were less likely to start or complete CPT, suggesting that these factors may hinder access to effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Initiation and Engagement of Cognitive Processing Therapy Among Veterans With PTSD Enrolled in Collaborative Care. Grubbs, KM., Fortney, JC., Pyne, JM., et al.[2018]

The UKV-CRAFT program was positively received by key stakeholders, indicating it effectively addresses the needs of concerned significant others (CSOs) of military personnel with PTSD and common mental disorders, filling a gap in existing support services.

Feedback from participants highlighted that UKV-CRAFT improved CSO well-being and communication with their loved ones, suggesting it could be a valuable intervention to encourage timely help-seeking for mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Community Reinforcement and Family Therapy in the UK military community. Croak, B., Archer, M., Harwood, H., et al.[2023]

A brief family intervention (BFI) significantly reduced dropout rates from trauma-focused treatment for PTSD among veterans, with only 20% of participants dropping out compared to 40% in the control group.

Both groups showed large decreases in PTSD symptoms over time, indicating that while the BFI helped with retention, it did not affect the overall efficacy of the trauma-focused therapies like cognitive processing therapy (CPT) or prolonged exposure (PE).

NCBI (Pubmed)

pubmed.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. Thompson-Hollands, J., Lee, DJ., Sloan, DM.[2022]

The STRONG STAR Training Initiative was launched in 2017 to provide competency-based training in evidence-based therapies for PTSD to community mental health providers serving veterans, addressing the gap in training opportunities outside of the VA.

The program aims to enhance the quality of care for veterans with PTSD by equipping clinicians with effective treatment strategies, and it plans to expand to include more interventions and reach additional locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Launching a Competency-Based Training Program in Evidence-Based Treatments for PTSD: Supporting Veteran-Serving Mental Health Providers in Texas. Dondanville, KA., Fina, BA., Straud, CL., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11291835

Project Details - NIH RePORTER Initial findings from an NC- PTSD-funded pilot of CIC+VA-CRAFT suggest that this brief, blended intervention is feasible, acceptable, and potentially more ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40320070/

Protocol for a randomized controlled trial This paper describes a randomized controlled trial of the Veterans Affairs-CRAFT (VA-CRAFT) web program coupled with four telephone coaching calls.

3. academic.oup.com academic.oup.com/milmed/article/189/7-8/e1403/7619615

Preliminary Investigation Into the Effectiveness of Group ... Analyses revealed significant pre-to-post improvement in both PTSD and depression outcomes with a large effect size for PTSD (Hedges' gav = 0.88) ...

4. withpower.com withpower.com/trial/phase-stress-disorders-post-traumatic-3-2021-6424b

CIC + VA-CRAFT for PTSD · Info for Participants 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714425001235

Promoting mental health treatment initiation of veterans ... We conducted an uncontrolled, pre-post pilot study to assess the feasibility, acceptability, and potential efficacy of CIC + VA-CRAFT among 12 spouses and ...

6. reporter.nih.gov reporter.nih.gov/project-details/11273191

Project Details - NIH RePORTER Initial findings from an NC- PTSD-funded pilot of CIC+VA-CRAFT suggest that this brief, blended intervention is feasible, acceptable, and potentially more ...

7. clinicaltrial.be clinicaltrial.be/fr/details/53705?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

A Randomized Controlled Trial of Coaching Into Care With... 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 ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04501328/a-randomized-controlled-trial-of-coaching-into-care-with-va-craft-to-promote-veteran-engagement-in-ptsd-care

A Randomized Controlled Trial of Coaching Into Care With VA ... Posttraumatic stress disorder (PTSD) afflicts many war Veterans, but often they are reluctant to seek help despite availability of effective treatments.

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/92/NCT03364192/Prot_SAP_000.pdf

PEER-DELIVERED WHOLE HEALTH COACHING TO IMPROVE ... Prevalence of posttraumatic stress disorder in Veterans Affairs primary care clinics. General hospital psychiatry. 2005;27(3):169-179. 14. Seal KH ...