Phase 2 PTSD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For the Veteran:

• Veterans aged 18 or older who have been diagnosed with PTSD (using a standard clinical assessment) with symptoms of at least moderate severity, and where at least 3 months have passed since the traumatic event
• Veterans whose psychiatric medications (if any) have remained unchanged for at least 4 weeks
• Veterans who are enrolled and eligible to receive care at the VA San Diego Healthcare System

For the Veteran's partner:

• Intimate partners aged 18 or older who are willing to take part in the treatment — partners who are also Veterans may be eligible, but must not screen positive for possible PTSD on a standard checklist

For both the Veteran and partner:

• Couples who are married or have been living together for at least 6 months
• Couples who are willing to be randomly assigned to either of the two treatment options being studied
• Couples who agree to have their assessment and therapy sessions audio or video recorded
• Couples who agree not to pursue other individual trauma-focused therapy for PTSD or any couples therapy during the treatment phase of the study
• Couples who have the ability to participate in virtual (online) sessions, including access to a reliable internet connection (DSL or cable) and a private space

Who may not be able to join:

For either member of the couple:

• Either person has a current substance use or alcohol problem that has not been in remission for at least 3 months, based on standard screening tools
• Either person currently has an uncontrolled psychotic disorder, as identified through a clinical screening process (confirm with trial site)
• Either person is currently at imminent risk of suicide or harming others, as assessed using a standard safety screening tool
• Either person has a severe cognitive or medical condition that would make it difficult to attend weekly couples therapy sessions
• Either person has carried out severe physical or sexual violence against a partner, or has used fear or intimidation in the relationship, in the past year, as identified through standard relationship safety assessments

For the Veteran only:

• Serious ongoing medical conditions, including heart disease, blood pressure that is too low (systolic below 100 mmHg) or too high (systolic above 130 mmHg or diastolic above 80 mmHg), or hormonal/metabolic conditions such as diabetes — the study physician makes this determination after a one-on-one appointment and review of the Veteran's medical history (confirm with trial site)
• A positive screen for borderline personality disorder on a standard screening tool, with final determination made through a clinical case review (confirm with trial site)
• Current pregnancy, having given birth in the past 6 months, currently breastfeeding, or being capable of becoming pregnant without using an effective contraception method during the study — negative pregnancy tests are required before starting and before each medication session, and effective contraception must be used from the start of the study until the end of treatment (confirm with trial site for full details)
• A known allergy to any of the preservatives used in the oxytocin nasal spray used in this study (these include Methylparaben, Propylparaben, Glycerin, Sodium Benzoate, Potassium Sorbate, and Disodium EDTA)

Important: Always verify eligibility with the trial site directly before applying.