CIC + VA-CRAFT for PTSD

Recruiting in Palo Alto (17 mi)

Overseen by Steven L. Sayers, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Domestic violence, Severe intimate partner violence

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{3 6 9 10 11}

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

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.

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.

Trial 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 (Behavioral Intervention)
• CIC+VA-CRAFT (Behavioral Intervention)

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

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

VA Palo Alto Health Care System, Palo Alto, CA Palo Alto, CA

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1691

Patients Recruited

3,759,000+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Patients Recruited

355,000+

Corporal Michael J. Crescenz VA Medical Center

Collaborator

Trials

31

Patients Recruited

9,900+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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]