NCT05491486: OXYGEN

Mindfulness, Empathy and the Oxytocinergic System in Persons With Schizophrenia

Status unknown NA Last updated 8 August 2022

What this trial tests

NA trial testing Mindfulness-based Group Therapy in Schizophrenia Spectrum and Other Psychotic Disorders in 60 participants. Status unknown.

Timeline

15 June 2022

Primary endpoint
15 July 2023

15 July 2023

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	15 June 2022
Primary completion	15 July 2023
Estimated completion	15 July 2023
Sites	1 location across Germany

Drugs / interventions tested

• Mindfulness-based Group Therapy

Conditions studied

• Schizophrenia Spectrum and Other Psychotic Disorders — all drugs for Schizophrenia Spectrum and Other Psychotic Disorders →

Sponsor

Charite University, Berlin, Germany

Who can join

Adults 18 to 65, any sex, with Schizophrenia Spectrum and Other Psychotic Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recent studies indicated positive effects of mindfulness-based interventions (MBI) for schizophrenia (SCZ), but also on oxytocin (OXT) levels in healthy persons. It was also shown that response to MBI could be shaped by genetic factors. However, the interplay between mindfulness and empathy and genetic factors with the oxytocinergic system has not yet been examined in SCZ. The aim of the current explorative study is to (1) explore the effect of mindfulness-based group therapy (MBGT) on OXT levels as well as empathy in persons with SCZ; (2) investigate whether polygenic risk scores (PRS) for empathy can predict empathy levels in persons with SCZ; (3) investigate whether PRS for empathy and specific genetic configurations in the oxytocin receptors are associated with MBGT outcomes and OXT levels; 4) examine changes in positive- and negative symptoms, depression, anxiety, social functioning, and mindfulness at a within-group level and between both conditions.

A parallel-group, proof-of-concept randomized controlled trial with 30 participants allocated to each trial arm (N = 60) will be conducted. Participants will be randomly assigned to MBGT alongside treatment as usual (MBGT+TAU) or treatment as usual (TAU). For a treatment period of four weeks, participants will receive weekly MBGT sessions. Four weeks after baseline assessments (T0), post-intervention assessments (T1) will take place. As a pilot study, effect sizes will be estimated for within- and between-group effects with corresponding confidence intervals.

Outcomes of our proof-of-concept study can provide insight into potential biological mechanisms underlying mindfulness in SCZ, determine a valid biomarker associated with empathy and negative symptoms and pave the way for a personalized treatment approach for individuals with SCZ.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The relationship between mindfulness and empathy with the oxytocinergic system in persons with schizophrenia spectrum disorders - A proof-of-concept randomized controlled trial (OXYGEN).
   Böge K, Bergmann N, Zierhut M, Hahne I, et al · · 2024 · cited 3× · PMID 39308779 · DOI 10.1016/j.ijchp.2024.100503
2. The relationship between mindfulness, psychological flexibility, and symptom severity in persons with schizophrenia-spectrum-disorders: a cross-sectional study.
   Hahne I, Segerer J, Zierhut M, Bergmann N, et al · · 2025 · cited 1× · PMID 40467751 · DOI 10.1038/s41598-025-03380-2
3. Changes of psychological and biological stress parameters in individuals with schizophrenia spectrum disorders participating in a mindfulness-based group therapy.
   Zierhut M, Koop S, Bergmann N, Hahne I, et al · · 2026 · PMID 42062279 · DOI 10.1038/s41537-026-00759-6