Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD

Open to people ages 18 years and up

Inclusion criteria for Veterans

1. Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5) no less than 3 months after the index trauma occurred (to allow for potential natural recovery)
2. Be on a stable psychoactive medication regimen for at least 2 months (if eligible)
3. Veteran must be enrolled and eligible to receive care at the VASDHS

4. If able to become pregnant, have a highly sensitive negative urine pregnancy test at study entry and prior to each medication administration during treatment, and agree to use effective birth control methods from study entry until conclusion of treatment to prevent pregnancy. Pregnancy testing can be waived on a case-by-case basis with PI approval. 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, and bilateral oophorectomy. Effective birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, oral hormones, a barrier contraception method (e.g., male or female condoms, diaphragm, cap), or vasectomized sole sexual partner.

   Inclusion criteria for Partners

5. Be an intimate partner (age 18 or older) who is willing to participate in the intervention (partners can also be Veterans but cannot meet criteria for possible PTSD per the PCL-5)

   Inclusion criteria for Veterans and Partner dyads

6. Be married, or cohabitating for at least 6 months
7. Willing to be randomized into both treatment conditions
8. Agree to have assessment and treatment sessions audio/video recorded
9. Agree not to receive other individual or conjoint trauma-focused psychotherapy for PTSD during the treatment portion of the study
10. Have the capacity to participate in virtual care (access to internet via DSL or a cable provider, private space)

Exclusion criteria for Veterans and Partners

1. Current substance dependence in either member of the couple not in remission for at least 3 months, as assessed by the Alcohol Use Disorders Identification Test (AUDIT) and Drug Abuse Screening Test (DAST)
2. Any current uncontrolled psychotic disorder in either member of the couple as assessed by the Prime Screen-Revised (PS-R)
3. Positive screen (7+) for borderline personality disorder (BPD) in either member of the couple as assessed by the MacLean Screening Instrument for BPD
4. Imminent suicidality or homicidality in either member of the couple (e.g., C-SSRS)
5. Any severe cognitive or medical impairment in either member of the couple making it difficult to regularly attend weekly couples psychotherapy
6. Any perpetration of severe physical or sexual relationship aggression (as assessed by the CTS-2) or fear/intimidation (3-item IPV screen, Couples Questionnaire) in the past year
7. Pregnancy, breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception (listed above and for PTSD+ Veteran only).

Exclusion criteria for Veteran receiving medication

1. Uncontrolled hypotension (systolic blood pressure <100 mm Hg) or hypertension (systolic BP >130 or diastolic BP > 80 mm Hg) as assessed by self-report and verified with VA chart review. All veterans will also complete a blood pressure reading within a week of completed informed consent/baseline assessment appointment via the strategy that they find most preferable-(1) via an in-person BP reading by a trained professional at VA, (2) via telehealth using a device sent to their home by our research team, in which our staff will directly observe the use of the device and the reading to ensure that it was used properly and that the reading is accurate, (3) via a reading at their local provider's clinic or pharmacy with a BP kiosk (after which they would meet with study staff via telehealth to have the medical record or photo documentation of the reading with time and date visually verified); or (4) via telehealth with their own BP monitor at home while following study instructions for the most accurate reading, in which our staff will directly observe the use of the device and the reading to ensure that it was used properly and that the reading is accurate. Any potential participants for whom we have elevated concern about safety of intranasal oxytocin (per chart review of ongoing risk factors, health history, and concomitant medications) after consulting with our psychiatrist will be asked to attend an in-person visit at a VA medical center, clinic, or the Veterans Medical Research Foundation before enrollment to rule out uncontrolled hypotension or hypertension.
2. Pregnancy, delivery in the past 6 months, current breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception listed above. A highly sensitive negative urine pregnancy test must be verified visually by research staff at study entry via telehealth or in-person at the Veterans Medical Research Foundation. Research staff will also visually verify a negative pregnancy test result via telehealth prior to each medication administration during treatment. Veteran must also verbally confirm that they completed the test themselves that day. Pregnancy testing can be waived on a case-by-case basis with PI approval.
3. Known allergy to preservatives (i.e., Methylparaben, Propylparaben, Glycerin, Sodium Benzoate, Potassium Sorbate, and Disodium EDTA) utilized in oxytocin nasal spray.