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

NCT02685358 | Completed Results DMC

• 2 other identifiers: IIR 14-288HX-001790-1
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 2

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Stress Disorders, Post-traumatic; Primary Health Care; Mobile Applications; Veterans

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

  The CAPS-5 is a 30-item clinical interview that assesses the 20 DSM-5 PTSD symptoms. Scores on the CAPS-5 can range from 0 to 80, with higher scores reflecting worse PTSD symptom severity. In this study, clinician-rated PTSD symptom severity were based on blind assessor ratings.

  Baseline

• Hospital Administrative Data Showing 2 Mental Health Visits Completed

  Hospital administrative data will be examined to determine if the participant completed 2 visits to any specialty mental health clinic during the follow-up period.

  16 and 24 weeks

Secondary Outcomes (5)

• PTSD Checklist-5 (PCL-5)

  Baseline, 8 week, 16 week, 24 week

• Client Satisfaction Questionnaire (CSQ)

  8 week

• Patient Health Questionnaire (PHQ-9)

  Baseline, 8 week, 16 week, 24 week

• WHOQOL-BREF Psychological Health Subscale

  Baseline, 8 week, 16 week, 24 week

• WHOQOL-BREF Social Relationships Subscale

  Baseline, 8 week, 16 week, 24 week

Study Arms (2)

Clinician-Supported PTSD Coach

EXPERIMENTAL

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

Primary Care Mental Health Integrated Care as Usual

ACTIVE COMPARATOR

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

Behavioral: Primary Care Mental Health Integrated Care as Usual

Interventions

Clinician-Supported PTSD Coach BEHAVIORAL

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.

Clinician-Supported PTSD Coach

Primary Care Mental Health Integrated Care as Usual BEHAVIORAL

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

Primary Care Mental Health Integrated Care as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

Location

Related Publications (1)

• 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.

  PMID: 36932268 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Eric Kuhn, PhD
• Organization: VA Palo Alto Health Care System

eric.kuhn@va.gov

650-493-5000

Study Officials

• Eric R Kuhn, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 18, 2016
• Study Start: March 1, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)