An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT02685358

Collaborator

(none)

234

Enrollment

Locations

Arms

Actual Duration (Months)

117

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project seeks to improve health care for Veterans by testing the effectiveness of a primary care-based treatment called clinician-supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. If this treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Behavioral: Clinician-Supported PTSD Coach Behavioral: Primary Care Mental Health Integrated Care as Usual	N/A

Detailed Description

Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project represents a unique opportunity to improve health care for Veterans by examining the effectiveness of a primary care-based treatment called Clinician-Supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. This randomized clinical trial will enroll and treat 260 VA primary care patients (female and male) who have PTSD and are not currently being treated for it. Commonly used, well-established clinical interviews and self-report measures will be used to assess important clinical outcomes. If this direct treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.

Study Design

Study Type:

Interventional

Actual Enrollment :

234 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Clinician-Supported PTSD Coach (CS PTSD Coach) consists of four 20-30 minute sessions focused on instructions for using the PTSD Coach app, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for completion between sessions. PC-MHI providers deliver CS PTSD Coach using a treatment manual, which was developed and piloted by the PIs. Session 1 will be face-to-face and sessions 2-4 may be face-to-face or by phone, depending on patient preference. To help participants overcome treatment barriers psycho-education about treatment options are provided and active problems solving is encouraged. Specific next steps for treatment or self-management are developed collaboratively, typically in session 4. After session 4, Participants are encouraged to continue using PTSD Coach and have access to the research version of the app until the 24-week follow-up.Clinician-Supported PTSD Coach (CS PTSD Coach) consists of four 20-30 minute sessions focused on instructions for using the PTSD Coach app, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for completion between sessions. PC-MHI providers deliver CS PTSD Coach using a treatment manual, which was developed and piloted by the PIs. Session 1 will be face-to-face and sessions 2-4 may be face-to-face or by phone, depending on patient preference. To help participants overcome treatment barriers psycho-education about treatment options are provided and active problems solving is encouraged. Specific next steps for treatment or self-management are developed collaboratively, typically in session 4. After session 4, Participants are encouraged to continue using PTSD Coach and have access to the research version of the app until the 24-week follow-up.

Masking:

Single (Outcomes Assessor)

Masking Description:

The CAPS-5 will be administered via phone by a central assessor, blind to condition, at baseline and post-treatment and will be the primary measure of change in PTSD symptom severity.

Primary Purpose:

Health Services Research

Official Title:

An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clinician-Supported PTSD Coach Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.	Behavioral: Clinician-Supported PTSD Coach Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
Active Comparator: Primary Care Mental Health Integrated Care as Usual Existing primary care mental health integrated treatment will serve as the comparison condition	Behavioral: Primary Care Mental Health Integrated Care as Usual Existing primary care mental health integrated treatment will serve as the comparison condition

Arm

Intervention/Treatment

Experimental: Clinician-Supported PTSD Coach

Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.

Behavioral: Clinician-Supported PTSD Coach

Active Comparator: Primary Care Mental Health Integrated Care as Usual

Existing primary care mental health integrated treatment will serve as the comparison condition

Behavioral: Primary Care Mental Health Integrated Care as Usual

Existing primary care mental health integrated treatment will serve as the comparison condition

Outcome Measures

Primary Outcome Measures

Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [8 weeks]
Clinician-rated PTSD symptom severity based on blind assessor ratings
Hospital administrative data showing 2 mental health visits for PTSD completed [16 and 24 weeks]
Hospital administrative data will be examined to determine if the participant completed 2 visits to any specialty mental health clinic for PTSD during the follow-up period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Veterans enrolled in primary care within the VA Syracuse and Palo Alto healthcare systems reporting 33 on the PTSD Checklist-5 (PCL-5) and a traumatic event on the Criterion A screener

Exclusion Criteria:

Patients will be excluded if they demonstrate symptoms that would not allow them to actively engage in the CS PTSD Coach, i.e.,
gross cognitive impairment
Current symptoms of mania or psychosis or who have more pressing concerns that need to be addressed first, i.e.,
suicide attempt in the last two months or current intent to commit suicide
Patients with recent suicide attempts or intent are eligible to be enrolled follow the receipt of suicide prevention services
The investigators will also exclude patients that are already receiving psychotherapy or MH counseling for PTSD outside of PC
Started or changed the dose of a psychotropic medication for PTSD in the last two months that was prescribed outside of VA PC
Voice a preference to be directly referred to MH specialty care

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California	United States	94304-1290
2	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York	United States	13210