Clinical trial NCT02685358: An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach
Official title: An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Stress Disorders, Post-traumatic
Primary Health Care
Mobile Applications
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-02-18
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline
measure: Hospital Administrative Data Showing 2 Mental Health Visits Completed
timeFrame: 16 and 24 weeks
Secondary outcomes:
measure: PTSD Checklist-5 (PCL-5)
timeFrame: Baseline, 8 week, 16 week, 24 week
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 8 week
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 8 week, 16 week, 24 week
measure: WHOQOL-BREF Psychological Health Subscale
timeFrame: Baseline, 8 week, 16 week, 24 week
measure: WHOQOL-BREF Social Relationships Subscale
timeFrame: Baseline, 8 week, 16 week, 24 week
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Eric R Kuhn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Possemato K, Johnson E, Barrie K, Ghaus S, Noronha D, Wade M, Greenbaum MA, Rosen C, Cloitre M, Owen J, Jain S, Beehler G, Prins A, Seal K, Kuhn E. A Randomized Clinical Trial of Clinician-Supported PTSD Coach in VA Primary Care Patients. J Gen Intern Med. 2023 Jul;38(Suppl 3):905-912. doi: 10.1007/s11606-023-08130-6. Epub 2023 Mar 17.