Sequenced Treatment Effectiveness for Posttraumatic Stress

PHASE4CompletedINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

June 1, 2020

Primary Completion Date

August 1, 2024

Study Completion Date

August 1, 2024

Conditions
PTSD
Interventions
DRUG

Selective serotonin reuptake inhibitor

Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).

DRUG

Serotonin-norepinephrine reuptake inhibitor

Prescribers will prescribe venlafaxine.

BEHAVIORAL

Written Exposure Therapy

Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation about symptoms of PTSD, provides a treatment rationale for approaching the trauma memory, and discusses the use of writing as a means of doing so. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The session ends with the therapist instructing the patient to allow themselves to experience any trauma-related memories, images, thoughts, and feelings in the interval between sessions. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.

Trial Locations (15)

29401

Ralph H. Johnson VA Medical Center, Charleston

45220

Cincinnati VA Medical Center, Cincinnati

48182

Family Medical Center of Michigan, Temperance

49109

Ann Arbor VA Medical Center, Ann Arbor

49930

Upper Great Lakes Family Health Center, Hancock

59802

Partnership Health Center, Missoula

72214

Little Rock VA Medical Center, North Little Rock

72301

East Arkansas Family Health Center, West Memphis

76301

North Central Texas Community Health Center, Wichita Falls

80045

VA Eastern Colorado Health Care, Aurora

92025

Neighborhood Healthcare, San Diego

92161

San Diego VA Medical Center, San Diego

97239

Portland VA Medical Center, Portland

98188

Healthpoint, SeaTac

01730

Bedford VA Medical Center, Bedford

All Listed Sponsors
collaborator

Stanford University

OTHER

collaborator

Boston University

OTHER

collaborator

Washington State University

OTHER

collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

University of Washington

OTHER

NCT04597190 - Sequenced Treatment Effectiveness for Posttraumatic Stress | Biotech Hunter | Biotech Hunter