Mindfulness, Empathy and the Oxytocinergic System in Persons With Schizophrenia

NCT05491486 | Unknown

• 1 other identifier: OXYGEN2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in oxytocin levels

  Venous blood samples will be taken to determine the basal oxytocin plasma to obtain an individual baseline and comparison level. Furthermore, saliva samples will be taken before and after each MBGT session to determine OXT levels.

  Baseline and week 4

• Change in empathy levels IRI

  Interpersonal Reactivity Index (IRI) The IRI measures empathy on four subscales: perspective taking, fantasy, empathic concern and personal distress. Each subscale consists of 4 items rated on a 7-point Likert scale. The internal consistent is satisfactory with a Cronbach´s alpha of .78.

  Baseline and week 4

• Change in empathy levels EQ

  Empathy Quotient (EQ) The EQ consists of 40 statements to which participants have to indicate the degree to which they agree or disagree. There are four response options: 'strongly agree', 'slightly agree', 'slightly disagree', 'strongly disagree'. 'Definitely agree' responses score two points and 'slightly agree' responses score one point on half the items, and 'definitely disagree' responses score two points and 'slightly disagree' responses score one point on the other half. The remainder of the response options score 0. Finally, Cronbach's alpha was 0.92, which is high.

  Baseline and week 4

Secondary Outcomes (8)

• Change in SMQ Mindfulness

  Baseline and week 4

• PSP Social Functioning

  Baseline

• Change in PANSS Positive, Negative, and General Symptoms

  Baseline and week 4

• Change in SNS Negative Symptoms

  Baseline and week 4

• Change in DASS Depression & Anxiety

  Baseline and week 4

Other Outcomes (1)

• Polygenic Risk Scores (PRS)

  Baseline

Study Arms (2)

Mindfulness-based Group Therapy (MBGT+TAU)

EXPERIMENTAL

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.

Behavioral: Mindfulness-based Group Therapy

Treatment as Usual

NO INTERVENTION

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.

Interventions

Mindfulness-based Group Therapy BEHAVIORAL

see above

Mindfulness-based Group Therapy (MBGT+TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, 1220, Germany

RECRUITING

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Kerem Böge, Dr. Dr.

CONTACT

(+49)30 - 450 517636; kerem.boege@charite.de

Niklas Bergmann, M.Sc.

CONTACT

(+49)30 - 450 517549; niklas.bergmann@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The condition will be revealed to the participants after all T0 assessments have been completed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Dr.

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 8, 2022
• Study Start: June 15, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)