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

What Was Tested

This registered phase 2 trial tested Oxytocin.

It had two arms (groups): Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin (experimental) and Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Placebo (placebo comparator).

Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal oxytocin.

Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal placebo solution.

The registry classes the interventions as behavioral and drug.

More on the Plan

The study will also explore the impact of intranasal oxytocin on potential mechanisms of action (i.e., communication skills, empathy, and trust). bCBCT is a modified PTSD-specific cognitive-behavioral psychotherapy attended by the couple that uses close relationships as the vehicle for recovery.

Across eight 75-minute sessions, this manualized therapy addresses the patient's PTSD and relationship functioning simultaneously via its focus on PTSD psychoeducation within relationship contexts, communication skills, behavioral approach exercises, and cognitive interventions.

Oxytocin is a 9-amino-acid nonapeptide hormone produced by the paraventricular and supraoptic nuclei of the hypothalamus that regulates human emotions, social cognition, and social behaviors.

Oxytocin is released to several brain areas, including the amygdala, hypothalamus, hippocampus, insula, and striatum, and effects are mediated by oxytocin receptors found in these regions.

Who Took Part

Enrollment: 240 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable). Be enrolled and eligible to receive care at the VASDHS. 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.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-10-28 with completion listed for 2028-09-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: PTSD diagnosis and severity change (time frame: Baseline - 6-months post treatment).

It also tracked 1 secondary outcome, for example Relationship satisfaction.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 240 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.