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New treatment option for Post-Traumatic Stress Disorder (PTSD)
Official title Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
ClinicalTrials.gov ID: NCT06194851
What this study is testing
What is Oxytocin nasal spray?
Oxytocin nasal spray is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for post-traumatic stress disorder (ptsd).
Also referred to as Pitocin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Leveraging veterans' intimate relationships during treatment for posttraumatic stress disorder (PTSD) has the potential to concurrently improve PTSD symptoms and relationship quality. Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) is a manualized treatment designed to simultaneously improve PTSD and relationship functioning for couples in which one partner has PTSD.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for Veteran:
- Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5 with a minimum severity score of 25) no less than 3...
- Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable)
- Be enrolled and eligible to receive care at the VASDHS for Partner:
- 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...
You likely can't join if
- Exclusion criteria for Veteran and Partner:
- Current substance dependence in either member of the couple not in remission for at least 3 months, as assessed by the Alcohol Use Disorders...
- Any current uncontrolled psychotic disorder in either member of the couple as assessed by positive screen on the Prime Screen-Revised (PS-R)...
- 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 it difficult to regularly attend weekly couples psychotherapy
- Any perpetration of severe physical or sexual relationship aggression (as assessed by the CTS-2) or fear/intimidation (3-item IPV screen, Couples...
See the full eligibility criteria
- for Veteran:
- Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5 with a minimum severity score of 25) no less than 3 months after the index trauma occurred (to allow for potential natural...
- Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable)
- Be enrolled and eligible to receive care at the VASDHS for Partner:
- 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) for Veteran and Partner:
- Be married, or cohabitating for at least 6 months
- Willing to be assigned by chance 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 any form of conjoint therapy during the treatment portion of the study
- Have the capacity to participate in virtual care (access to internet via DSL or a cable provider, private space)
- Exclusion criteria for Veteran and Partner:
- 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)74 and Drug Abuse Screening Test (DAST)75
- Any current uncontrolled psychotic disorder in either member of the couple as assessed by positive screen on the Prime Screen-Revised (PS-R). Exclusion to be determined 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 it difficult to regularly attend weekly couples psychotherapy
- 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 Exclusion criteria for Veteran:
- Severe ongoing medical problems, including heart disease, uncontrolled hypotension (systolic blood pressure \ 130 or diastolic BP \> 80 mm Hg), and neuroendocrinological disorders (e.g., diabetes). Exclusion to be...
- Positive screen (7+) for borderline personality disorder (BPD) as assessed by the MacLean Screening Instrument for BPD76. Exclusion to be determined following case consult by PI or other clinician.
- Pregnancy, delivery in the past 6 months, current breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception. If able to become pregnant, Veteran must have a highly...
- Known allergy to preservatives (i.e., Methylparaben, Propylparaben, Glycerin, Sodium Benzoate, Potassium Sorbate, and Disodium EDTA) utilized in oxytocin nasal spray.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.