Mindfulness, Empathy and the Oxytocinergic System in Persons With Schizophrenia

NCT ID: NCT05491486

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-07-15

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.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mindfulness-based Group Therapy (MBGT+TAU)

Participants randomized into the experimental condition attend MBGT for four weeks in addition to regular university hospital outpatient treatment as usual (TAU). Overall, the core modules of the program are based on mindfulness-based cognitive therapy, taking into account both Chadwick's recommendations for implementing mindfulness in psychosis as well as patient feedback. Each week, a new topic is introduced to enhance the understanding of four core aspects of mindfulness (breath, senses, detachment, and body awareness). The therapy sessions will be held by a psychotherapist in training in cognitive behavioral therapy with over three years of experience in mindfulness practice and supervised by a psychotherapist with more than a decade of experience in mindfulness-based therapeutic approaches. Within the sessions, short periods of meditation are used to avoid prolonged periods of silence, and basic anchoring techniques and easy-to-understand language are used.

Group Type: EXPERIMENTAL

Mindfulness-based Group Therapy

Intervention Type: BEHAVIORAL

see above

Treatment as Usual

All participants will be recruited from the outpatient facility at the Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin and therefore, the heterogeneity of the obtained treatment options can be limited. As the standard procedure in our outpatient facility, patients will be seen monthly by a psychiatrist as well as individual sessions by a psychotherapist or psychiatric nurse (1:2 ratio). Hence, regardless of the study condition, all participants will obtain high standard health care at a renowned university hospital outpatient facility according to official national and international treatment guidelines providing pharmacological therapy, psychological consultation, and, on-demand, psychosocial support by social workers. The amount of psychotherapy received and on-demand psychosocial support will be recorded during the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness-based Group Therapy

see above

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brain & Behavior Research Foundation

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Kerem Böge

Dr. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Kerem Böge, Dr. Dr.

Role: CONTACT

kerem.boege@charite.de

(+49)30 - 450 517636

Niklas Bergmann, M.Sc.

Role: CONTACT

niklas.bergmann@charite.de

(+49)30 - 450 517549

Facility Contacts

Kerem Böge, Dr. Dr.

Role: primary

Kerem.boege@charite.de

49 30 450 517 789

Other Identifiers

OXYGEN2022

Identifier Type: -

Identifier Source: org_study_id