Oxytocin-augmented Cognitive-behavioral Group-based Short-term Intervention for Loneliness

What Was Tested

The trial (phase 1) is built around Oxytocin.

The purpose of this study is to evaluate the clinical potential of oxytocin (OT) as an adjunct to a cognitive-behavioral group-based shortterm intervention for participants suffering from loneliness.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

Intranasal administration of a placebo spray 30 minutes before the start of four intervention sessions.

The registry classes the interventions as drug.

More on the Plan

At the neural level, several networks may be involved in loneliness, including the reward circuitry, which mediates social reward, and the amygdala, which signals social threat.

Intranasal OT has been reported to regulate activity in both the reward system and the amygdala.

Therefore, it may serve as an adjunct to a cognitive-behavioral short-term intervention for high lonely participants.

Healthy, but high lonely participants will complete functional magnetic resonance imaging (fMRI) tasks in a separate testing session before the start of the intervention (testing session 1).

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: UCLA loneliness scale score equal to or greater than 55.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: current psychiatric illness; current psychiatric medication or psychotherapy; MRI contraindication (e.g. metal in body, claustrophobia).

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

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

It started in 2019-09-26 with completion listed for 2020-09.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Scores on the UCLA Loneliness Scale (time frame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)). State loneliness (numeric rating scale) (time frame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)). Scores on the World Health Organization (WHO) Five Well-Being Index (time frame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)).

It also tracked 2 secondary outcomes, for example Interpersonal distance and Neural activity at resting state.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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