Clinical trial NCT05491486: Mindfulness, Empathy and the Oxytocinergic System in Persons With Schizophrenia
Official title: The Relationship Between Mindfulness and Empathy With the Oxytocinergic System in Persons With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2022-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* be aged between 18 and 65
* meet diagnostic criteria for schizophrenia (ICD-10: F20.X) ascertained by a trained psychiatrist
* sufficient German language proficiency to engage with the intervention
* no recent (\<4 weeks) major change in psychopharmacologic medication
* be able to give written informed consent

Exclusion Criteria:

* a score of 7 on any item of the positive scale of PANSS, suggesting severe psychotic symptoms
* acute suicidality
* current substance use other than nicotine
* neurological disorders or brain damages

Primary outcomes:
measure: Change in oxytocin levels
timeFrame: Baseline and week 4
measure: Change in empathy levels IRI
timeFrame: Baseline and week 4
measure: Change in empathy levels EQ
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Change in SMQ Mindfulness
timeFrame: Baseline and week 4
measure: PSP Social Functioning
timeFrame: Baseline
measure: Change in PANSS Positive, Negative, and General Symptoms
timeFrame: Baseline and week 4
measure: Change in SNS Negative Symptoms
timeFrame: Baseline and week 4
measure: Change in DASS Depression & Anxiety
timeFrame: Baseline and week 4
measure: Change in CFQ Psychological Flexibility
timeFrame: Baseline and week 4
measure: Change in PANAS Positive and Negative Affect
timeFrame: Baseline and week 4
measure: Change in BIRT Motivation (BMQ)
timeFrame: Baseline and week 4
Other outcomes:
measure: Polygenic Risk Scores (PRS)
timeFrame: Baseline
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Study officials:
References: