Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder (PTSD)

NCT03581981 | Completed Results DMC

• 1 other identifier: D2625-R
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed project will examine a promising brief therapy for posttraumatic stress Disorder (PTSD) for use in Veterans Health Administration (VHA) Primary Care and its impact on functional outcomes. This intervention will provide an alternative point of access to effective PTSD treatment and improved function that does not require referral to specialty mental health and accomplishes improved function in a short-term, brief protocol. Many Veterans prefer to receive mental health care, including PTSD service in primary care. The current protocol would allow them to access effective therapy options in addition to the medication management that is currently the standard of care for PTSD in primary care. In addition, this brief protocol may reduce the number of specialty mental health referrals as many Veterans may not require additional PTSD specific treatment after completion. Thus, if effective, this protocol will greatly increase Veteran treatment choice and improve functional outcomes and access while also increasing efficiency of allocation of specialty PTSD services.

Conditions

Posttraumatic Stress Disorder

Keywords

posttraumatic stress disorder

Outcome Measures

Primary Outcomes (3)

• World Health Organization Disability Assessment Scale 2.0 Change

  Change in total score between Week 6 and Week 0 time points can range from 144 (total disability after full function) to 0 (no change) to -144 (total recovery of all function after total disability). Lower change scores reflect more return of function between timepoints. Cut points for this measure have not yet been established.

  Week 6 to Week 0

• World Health Organization Disability Assessment Scale 2.0

  WHODAS is a 36-item disability interviewer administered assessment covering six domains of function: cognition, mobility, self-care, getting along, life activities, and participation. Each item is scored as none, mild, moderate, severe, or extreme/cannot do. Simple scoring where items are summed across the scale was used. Total scores can range from range from 0 (no disability) to 144 (full disability) with higher scores indicate greater functional impairment.

  Week 12

• World Health Organization Disability Assessment Scale 2.0

  WHODAS is a 36-item disability interviewer administered assessment covering six domains of function: cognition, mobility, self-care, getting along, life activities, and participation. Each item is scored as none, mild, moderate, severe, or extreme/cannot do. Simple scoring where items are summed across the scale was used. Total scores can range from range from 0 (no disability) to 144 (full disability) with higher scores indicate greater functional impairment.

  Week 24

Secondary Outcomes (9)

• Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change

  Week 6 to Week 0

• PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change

  Week 6 to Week 0

• Patient Health Questionnaire- 9 (PHQ-9) Change

  Week 6 to week 0

• Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)

  Week 12

• Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)

  Week 24

Study Arms (2)

Prolonged Exposure for Primary Care (PE-PC)

EXPERIMENTAL

Brief version of PE provided in 30 minute sessions in PC

Behavioral: Prolonged Exposure for Primary Care (PE-PC)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Veterans assigned to Primary Care (PC) Mental Health Integration (PCMHI)- Treatment as Usual (TAU) will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty Mental Health (MH)), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.

Behavioral: Treatment as Usual

Interventions

Prolonged Exposure for Primary Care (PE-PC) BEHAVIORAL

Brief version of Prolonged Exposure (PE) provided in 30 minute sessions in primary care (PC)

Also known as: PE-PC

Prolonged Exposure for Primary Care (PE-PC)

Treatment as Usual BEHAVIORAL

Veterans assigned to Primary Care (PC) Mental Health Integration (PCMHI)-Treatment as Usual (TAU) will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.

Also known as: TAU

Treatment as Usual (TAU)

Eligibility Criteria

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

You may qualify if:

• Any era Veterans seeking care in VA PC for PTSD symptoms \[PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) of at least 28)\] and PTSD confirmed based on Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
• English speaking
• Report significant impairment in function related to PTSD symptoms as noted on intake World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
• Report that they want treatment for PTSD
• If individuals are taking psychotropic medication, 2-weeks on stable dose will be required prior to enrollment

You may not qualify if:

• Other primary clinical issue that would interfere with PTSD treatment
• Level of suicidal risk as determined by the Columbia Suicide Severity Rating Scale (C-SSRS) that requires:
• PTSD + interested and consent to study
• Primary Care Provider (PCP) Screen:
• Primary Care- Posttraumatic Stress Disorder Screen (PC-PTSD) + Intake
• PCMHI Provider:
• \[PCL 28\] + brief interview
• No PTSD OR
• Not interested in treatment OR
• Not interested in study
• Severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can adhere to the study regimen
• Psychosis or unmanaged bipolar disorder
• Moderate to severe substance use disorder in the past 8 weeks
• Patients who are currently receiving talk therapy for trauma-related symptoms

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Ralph H. Johnson VA Medical Center: collaborator
• VA Ann Arbor Healthcare System: collaborator

Study Sites (2)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (3)

• Rauch SAM, Kim HM, Acierno R, Ragin C, Wangelin B, Blitch K, Muzzy W, Hart S, Zivin K, Cigrang J. Improving function through primary care treatment of PTSD: The IMPACT study protocol. Contemp Clin Trials. 2022 Sep;120:106881. doi: 10.1016/j.cct.2022.106881. Epub 2022 Aug 12.

  PMID: 35964868 BACKGROUND

• McLean CP, Back SE, Capone C, Morland L, Norman SB, Rauch SAM, Schnurr PP, Teng E, Acierno R. The Impact of COVID-19 on Psychotherapy Participation Among Individuals With Posttraumatic Stress Disorder Enrolled in Treatment Research. J Trauma Stress. 2022 Feb;35(1):308-313. doi: 10.1002/jts.22718. Epub 2021 Jul 22.

  PMID: 34291832 BACKGROUND

• Rauch SAM, Kim HM, Acierno R, Ragin C, Wangelin B, Blitch K, Muzzy W, Hart S, Zivin K. Improving function through primary care treatment of posttraumatic stress disorder study outcomes: A randomized controlled trial of prolonged exposure for primary care in veterans. Fam Syst Health. 2023 Dec;41(4):502-513. doi: 10.1037/fsh0000823. Epub 2023 Aug 31.

  PMID: 37650808 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Primary Health Care; Therapeutics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

Note that the 2 PCMHI clinics in the current study employ primarily cognitive behavioral therapies (e.g., exposure, behavioral activation).

Results Point of Contact

• Title: Sheila Rauch
• Organization: Atlanta VAHCS

sheila.rauch@va.gov

404-321-6111

Study Officials

• Sheila A Rauch, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will not be aware of patient condition and patients will be instructed and reminded not to disclose information that may lead to unblinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 10, 2018
• Study Start: April 1, 2019
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: July 15, 2024
• Results First Posted: July 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)