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

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VA Office of Research and Development

Status

Completed

Conditions

Posttraumatic Stress Disorder

Treatments

Behavioral: Clinician-Supported PTSD Coach
Behavioral: Primary Care Mental Health Integrated Care as Usual

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02685358
HX-001790-1 (Other Grant/Funding Number)
IIR 14-288

Details and patient eligibility

About

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.

Full 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.

Enrollment

234 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

234 participants in 2 patient groups

Clinician-Supported PTSD Coach
Experimental group
Description:
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.
Treatment:
Behavioral: Clinician-Supported PTSD Coach
Primary Care Mental Health Integrated Care as Usual
Active Comparator group
Description:
Existing primary care mental health integrated treatment will serve as the comparison condition
Treatment:
Behavioral: Primary Care Mental Health Integrated Care as Usual

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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