Phase
Condition
Post-traumatic Stress Disorders
Stress
Treatment
Brief Cognitive-Behavioral Conjoint Therapy
Saline nasal spray
Oxytocin nasal spray
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Inclusion criteria for Veteran:
Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessedby the CAPS-5 with a minimum severity score of 25) no less than 3 months after theindex trauma occurred (to allow for potential natural recovery)
Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable)
Be enrolled and eligible to receive care at the VASDHS Inclusion criteria for Partner:
Be an intimate partner (age 18 or older) who is willing to participate in theintervention (partners can also be Veterans but cannot meet criteria for possiblePTSD per the PCL-5) Inclusion criteria for Veteran and Partner:
Be married, or cohabitating for at least 6 months
Willing to be randomized into either treatment condition (bCBCT + OT or bCBCT + PL)
Agree to have assessment and treatment sessions audio/video recorded
Agree not to receive other individual trauma-focused psychotherapy for PTSD or anyform of conjoint therapy during the treatment portion of the study
Have the capacity to participate in virtual care (access to internet via DSL or acable provider, private space)
Exclusion
Exclusion Criteria: Exclusion criteria for Veteran and Partner:
Current substance dependence in either member of the couple not in remission for atleast 3 months, as assessed by the Alcohol Use Disorders Identification Test (AUDIT)74 and Drug Abuse Screening Test (DAST)75
Any current uncontrolled psychotic disorder in either member of the couple asassessed by positive screen on the Prime Screen-Revised (PS-R). Exclusion to bedetermined following case consult by PI or other clinician.
Imminent suicidality or homicidality in either member of the couple (e.g., C-SSRS)
Any severe cognitive or medical impairment in either member of the couple making itdifficult to regularly attend weekly couples psychotherapy
Any perpetration of severe physical or sexual relationship aggression (as assessedby the CTS-2) or fear/intimidation (3-item IPV screen, Couples Questionnaire) in thepast year Exclusion criteria for Veteran:
Severe ongoing medical problems, including heart disease, uncontrolled hypotension (systolic blood pressure <100 mm Hg) or hypertension (systolic BP >130 or diastolicBP > 80 mm Hg), and neuroendocrinological disorders (e.g., diabetes). Exclusion tobe determined in collaboration with study physician following completion ofphysician's one-on-one appointment with Veteran and review of all relevantinformation (e.g., risk factors, health history, concomitant medications, etc.) fromVeteran's VA medical record and study screening/assessment processes includingselfreport measures and blood pressure measurement. Additionally, Veterans for whomthe study physician has elevated concern, will be asked to attend an in-person visitat a VA medical center, clinic, or the Veterans Medical Research Foundation beforeenrollment.
Positive screen (7+) for borderline personality disorder (BPD) as assessed by theMacLean Screening Instrument for BPD76. Exclusion to be determined following caseconsult by PI or other clinician.
Pregnancy, delivery in the past 6 months, current breastfeeding, or the ability tobecome pregnant while not practicing an effective method of contraception. If ableto become pregnant, Veteran must have a highly sensitive negative urine pregnancytest verified visually via telehealth or in-person at the Veterans Medical ResearchFoundation by research staff at study entry and prior to each medicationadministration during treatment. Veteran must verbally confirm that they completedthe test themselves that day. Veteran must also agree to use an effective birthcontrol method from study entry until conclusion of treatment to prevent pregnancy.The ability to become pregnant is defined as: assigned female at birth, fertile,following menarche and until becoming post-menopausal unless permanently sterile.Permanent sterilization methods include hysterectomy, bilateral salpingectomy, andbilateral oophorectomy. Effective birth control methods include intrauterine device (IUD), injected,implanted, intravaginal, or transdermal hormonal methods, oral hormones, a barriercontraception method (e.g., male or female condoms, diaphragm, cap), or vasectomizedsole sexual partner. Pregnancy tests will be purchased by the study and mailed to Veteran unless PI hasapproved waiver of testing requirement.
Known allergy to preservatives (i.e., Methylparaben, Propylparaben, Glycerin, SodiumBenzoate, Potassium Sorbate, and Disodium EDTA) utilized in oxytocin nasal spray.
Study Design
Study Description
Connect with a study center
VA San Diego Healthcare System, San Diego, CA
San Diego, California 92161-0002
United StatesActive - Recruiting

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