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

230 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

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

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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{5 8 9 10 11}

Who Is on the Research Team?

Eric R Kuhn, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Steven L. Sayers, PhD

Principal Investigator

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

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 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]

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]

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]

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]

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 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]

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 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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Improving function through primary care treatment of PTSD: The IMPACT study protocol. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Incorporating psychological debriefing techniques within a brief group psychotherapy programme for the treatment of post-traumatic stress disorder. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A Pilot Trial of Online Training for Family Well-Being and Veteran Treatment Initiation for PTSD. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Predictors of Initiation and Engagement of Cognitive Processing Therapy Among Veterans With PTSD Enrolled in Collaborative Care. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder collaborative care: A quality improvement study in veterans affairs primary care. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Community Reinforcement and Family Therapy in the UK military community. [2023]

7. United States 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States 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. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of an online, coach-assisted self-management PTSD intervention tailored for women veterans. [2022]

11. United States 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. [2022]