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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinician-Supported PTSD Coach
Primary Care Mental Health Integrated Care as Usual
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Posttraumatic Stress Disorder focused on measuring Stress Disorders, Post-traumatic, Primary Health Care, Mobile Applications, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA
  • Syracuse VA Medical Center, Syracuse, NY

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clinician-Supported PTSD Coach

Primary Care Mental Health Integrated Care as Usual

Arm 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.

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

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Clinician-rated PTSD symptom severity based on blind assessor ratings
Hospital administrative data showing 2 mental health visits for PTSD completed
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.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2016
Last Updated
November 4, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02685358
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Stress Disorders, Post-traumatic, Primary Health Care, Mobile Applications, Veterans

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinician-Supported PTSD Coach
Arm Type
Experimental
Arm 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.
Arm Title
Primary Care Mental Health Integrated Care as Usual
Arm Type
Active Comparator
Arm Description
Existing primary care mental health integrated treatment will serve as the comparison condition
Intervention Type
Behavioral
Intervention Name(s)
Clinician-Supported PTSD Coach
Intervention 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 consists of 4 brief sessions over 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Primary Care Mental Health Integrated Care as Usual
Intervention Description
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Description
Clinician-rated PTSD symptom severity based on blind assessor ratings
Time Frame
8 weeks
Title
Hospital administrative data showing 2 mental health visits for PTSD completed
Description
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.
Time Frame
16 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric R Kuhn, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
Syracuse VA Medical Center, Syracuse, NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28032921
Citation
Smith SK, Kuhn E, O'Donnell J, Koontz BF, Nelson N, Molloy K, Chang J, Hoffman J. Cancer distress coach: Pilot study of a mobile app for managing posttraumatic stress. Psychooncology. 2018 Jan;27(1):350-353. doi: 10.1002/pon.4363. Epub 2017 Feb 2. No abstract available.
Results Reference
result
PubMed Identifier
28103401
Citation
Rosen CS, Eftekhari A, Crowley JJ, Smith BN, Kuhn E, Trent L, Martin N, Tran T, Ruzek JI. Maintenance and Reach of Exposure Psychotherapy for Posttraumatic Stress Disorder 18 Months After Training. J Trauma Stress. 2017 Feb;30(1):63-70. doi: 10.1002/jts.22153. Epub 2017 Jan 19.
Results Reference
result
PubMed Identifier
28221061
Citation
Kuhn E, Kanuri N, Hoffman JE, Garvert DW, Ruzek JI, Taylor CB. A randomized controlled trial of a smartphone app for posttraumatic stress disorder symptoms. J Consult Clin Psychol. 2017 Mar;85(3):267-273. doi: 10.1037/ccp0000163.
Results Reference
result
PubMed Identifier
28592349
Citation
Gould CE, Zapata AML, Bruce J, Bereknyei Merrell S, Wetherell JL, O'Hara R, Kuhn E, Goldstein MK, Beaudreau SA. Development of a video-delivered relaxation treatment of late-life anxiety for veterans. Int Psychogeriatr. 2017 Oct;29(10):1633-1645. doi: 10.1017/S1041610217000928. Epub 2017 Jun 8.
Results Reference
result
PubMed Identifier
28813306
Citation
Morland LA, Greene CJ, Rosen CS, Kuhn E, Hoffman J, Sloan DM. Telehealth and eHealth interventions for posttraumatic stress disorder. Curr Opin Psychol. 2017 Apr;14:102-108. doi: 10.1016/j.copsyc.2016.12.003. Epub 2016 Dec 26.
Results Reference
result
PubMed Identifier
27234150
Citation
Possemato K, Kuhn E, Johnson EM, Hoffman JE, Brooks E. Development and refinement of a clinician intervention to facilitate primary care patient use of the PTSD Coach app. Transl Behav Med. 2017 Mar;7(1):116-126. doi: 10.1007/s13142-016-0393-9. Erratum In: Transl Behav Med. 2017 Mar;7(1):127.
Results Reference
result
PubMed Identifier
27234152
Citation
Possemato K, Kuhn E, Johnson EM, Hoffman JE, Brooks E. Erratum to: Development and refinement of a clinician intervention to facilitate primary care patient use of the PTSD Coach app. Transl Behav Med. 2017 Mar;7(1):127. doi: 10.1007/s13142-016-0415-7. No abstract available.
Results Reference
result
PubMed Identifier
28112520
Citation
Laha SS, Naik AR, Kuhn ER, Alvarez M, Sujkowski A, Wessells RJ, Jena BP. Nanothermometry Measure of Muscle Efficiency. Nano Lett. 2017 Feb 8;17(2):1262-1268. doi: 10.1021/acs.nanolett.6b05092. Epub 2017 Jan 24.
Results Reference
result
PubMed Identifier
28130044
Citation
Kuhn E, Schwarz EI, Bratton DJ, Rossi VA, Kohler M. Effects of CPAP and Mandibular Advancement Devices on Health-Related Quality of Life in OSA: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):786-794. doi: 10.1016/j.chest.2017.01.020. Epub 2017 Jan 24.
Results Reference
result
PubMed Identifier
28293610
Citation
Ruzek JI, Kuhn E, Jaworski BK, Owen JE, Ramsey KM. Mobile mental health interventions following war and disaster. Mhealth. 2016 Sep 29;2:37. doi: 10.21037/mhealth.2016.08.06. eCollection 2016.
Results Reference
result
Citation
Reger GM, Browne KC, Campellone TR, Simons CE, Kuhn E, Fortney JC, Sayre G, Reisinger HS. Barriers and Facilitators to Mobile Application Use During PTSD Treatment: Clinician Adoption of PE Coach. Professional Psychology, Research and Practice. 2017 Dec 1; 48(6):510-517.
Results Reference
result
PubMed Identifier
29963560
Citation
Kuhn E, van der Meer C, Owen JE, Hoffman JE, Cash R, Carrese P, Olff M, Bakker A, Schellong J, Lorenz P, Schopp M, Rau H, Weidner K, Arnberg FK, Cernvall M, Iversen T. PTSD Coach around the world. Mhealth. 2018 May 25;4:15. doi: 10.21037/mhealth.2018.05.01. eCollection 2018.
Results Reference
result
PubMed Identifier
30148141
Citation
Owen JE, Kuhn E, Jaworski BK, McGee-Vincent P, Juhasz K, Hoffman JE, Rosen C. VA mobile apps for PTSD and related problems: public health resources for veterans and those who care for them. Mhealth. 2018 Jul 26;4:28. doi: 10.21037/mhealth.2018.05.07. eCollection 2018.
Results Reference
result
PubMed Identifier
29120247
Citation
Miller KE, Kuhn E, Owen JE, Taylor K, Yu JS, Weiss BJ, Crowley JJ, Trockel M. Clinician Perceptions Related to the Use of the CBT-I Coach Mobile App. Behav Sleep Med. 2019 Jul-Aug;17(4):481-491. doi: 10.1080/15402002.2017.1403326. Epub 2017 Dec 1.
Results Reference
result
PubMed Identifier
29074319
Citation
Herbst E, Pennington D, Kuhn E, McCaslin SE, Delucchi K, Batki SL, Dickter B, Carmody T. Mobile Technology for Treatment Augmentation in Veteran Smokers With Posttraumatic Stress Disorder. Am J Prev Med. 2018 Jan;54(1):124-128. doi: 10.1016/j.amepre.2017.08.016. Epub 2017 Oct 23.
Results Reference
result
PubMed Identifier
30590862
Citation
Yu JS, Kuhn E, Miller KE, Taylor K. Smartphone apps for insomnia: examining existing apps' usability and adherence to evidence-based principles for insomnia management. Transl Behav Med. 2019 Jan 1;9(1):110-119. doi: 10.1093/tbm/iby014.
Results Reference
result
PubMed Identifier
31854029
Citation
Gould CE, Loup J, Kuhn E, Beaudreau SA, Ma F, Goldstein MK, Wetherell JL, Zapata AML, Choe P, O'Hara R. Technology use and preferences for mental health self-management interventions among older veterans. Int J Geriatr Psychiatry. 2020 Mar;35(3):321-330. doi: 10.1002/gps.5252. Epub 2019 Dec 29.
Results Reference
result
PubMed Identifier
26524541
Citation
Ruzek JI, Eftekhari A, Rosen CS, Crowley JJ, Kuhn E, Foa EB, Hembree EA, Karlin BE. Effects of a comprehensive training program on clinician beliefs about and intention to use prolonged exposure therapy for PTSD. Psychol Trauma. 2016 May;8(3):348-355. doi: 10.1037/tra0000004. Epub 2015 Nov 2.
Results Reference
result

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

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