Brief Cognitive Behavioral Conjoint Therapy for PTSD With Adjunctive Intranasal Oxytocin

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

It had 1 arm (groups): Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin (experimental).

The registry classes the interventions as behavioral and drug.

More on the Plan

The premise that interpersonal relationships play a key role in resilience, risk, and recovery from trauma is supported by research showing a robust association between PTSD and social support.

In 2009, VA began an initiative to select evidence-based family therapies and train mental health providers in these treatments.

The VA has been disseminating CBCT since 2013.

CBCT is a PTSD-specific cognitive-behavioral psychotherapy attended by the couple that uses close relationships as the vehicle for recovery.

Who Took Part

The registry lists 20 actual participants took part.

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: Agree not to receive other individual or conjoint psychotherapy for PTSD during the treatment portion of the study. If already on psychoactive medication prior to study referral, Veteran participant must remain on a stable psychoactive medication regimen for at least 45 days.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: acute suicidality; active substance use disorder; severe ongoing medical problems, including heart disease and neuroendocrinological disorders (e.g., diabetes).

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Oxytocin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-01-17 with completion listed for 2022-09-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Couples Satisfaction Inventory-32 (time frame: baseline). Couples Satisfaction Inventory-32 (time frame: immediately after the intervention (approximately 2-months after baseline)). Couples Satisfaction Inventory-32 (time frame: three months post-treatment (approximately 5-months after baseline)).

It also tracked 6 secondary outcomes, for example PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5), PTSD Checklist for DSM-5 (PCL-5), PTSD Checklist for DSM-5 (PCL-5), Brief Inventory of Psychosocial Functioning, Brief Inventory of Psychosocial Functioning and Brief Inventory of Psychosocial Functioning.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Oxytocin in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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