Schizophrenia Spectrum and Other Psychotic DisordersOXYGENNCT05491486
Mindfulness, Empathy and the Oxytocinergic System in Persons With Schizophrenia
A study testing Mindfulness-based Group Therapy in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- Mindfulness-based Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jun 2022to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, 1220
Kerem Böge, Dr. Dr., 49 30 450 517 789, Kerem.boege@charite.de
About this study
Official title: The Relationship Between Mindfulness and Empathy With the Oxytocinergic System in Persons With Schizophrenia
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.
- Being tested
- Mindfulness-based Group Therapy
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Group TherapyBehavioural
see above
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 4
Secondary outcomes (8)
Change in SMQ Mindfulness
The SMQ comprises 16 items that are rated on a seven-point Likert-scale ranging from (6) "agree totally" to (0) "disagree totally". Consequently, the total score ranges from 0 to 96, with a higher score indicating higher mindfulness. The internal consistency of the German version of the SMQ was Cronbach's α = 0.89.
Measured: Baseline and week 4
PSP Social Functioning
The Personal and Social Performance Scale (PSP) is a rater-based questionnaire used to assess social functioning in patients with SSD. The PSP showed good test-retest reliability (ICC = 0.79) in patients with schizophrenia
Measured: Baseline
Change in PANSS Positive, Negative, and General Symptoms
The Positive and Negative Syndrome Scale (PANSS) is one of the most widely used rater instruments for the assessment of the presence and severity of psychotic symptoms. Each scale comprises seven statements which are rated by the interviewer using a seven-point Likert format (from 1= absent to 7= extreme). The PANSS is reported to have satisfactory internal consistency, good interrater reliability and construct validity.
Measured: Baseline and week 4
Change in SNS Negative Symptoms
This is a 20-item self-reported questionnaire with five subscales, namely alogia, avolition, anhedonia, social withdrawal and diminished emotional range. These subscales cluster on two factors, the apathy and emotional components. Participants can estimate the answer to each question on a scale from 0 (strongly disagree) to 3 (strongly agree). The scale was shown to have good internal consistency with Cronbach's alpha = .87.
Measured: Baseline and week 4
Change in DASS Depression & Anxiety
The 21-item Depression, Anxiety, and Stress Scale (DASS-21) is assessed on a four-point Likert-scale ranging from (0) "did not apply to me at all over the last week" to (3) "applied to me very much last week." It shows internal consistencies of α > 0.80 across the three subscales and has shown to be a useful measurement tool for patients with SSD.
Measured: Baseline and week 4
Change in CFQ Psychological Flexibility
The instrument is self-reports, which showed high internal consistency in previous studies.
Measured: Baseline and week 4
Change in PANAS Positive and Negative Affect
The PANAS contains 20 items, each consisting of an adjective describing an emotion. The participants have to select how applicable this adjective is to their current state from 1 (not at all) to 5 (extremely). Ten items are assigned to the positive (e.g. "Excited") as well as the negative scale (e.g. "Fearful"). The reliability of the PANAS ranges from .86 to .93.
Measured: Baseline and week 4
Change in BIRT Motivation (BMQ)
The BIRT Motivation Questionnaire comprises 34 statements rated on a 4-point likert scale (always, often, sometimes, never). Internal consistencies of the BMQ-S and BMQ-R were high (Cronbach's alpha=.94 \& .95 respectively).
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start15 Jun 2022
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum and Other Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Kerem Böge, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491486
- Sponsor's protocol ID
- OXYGEN2022
- Acronym
- OXYGEN
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Mindfulness and Empathy With the Oxytocinergic System in Persons With Schizophrenia
- ClinicalTrials.gov ID
- NCT05491486
- Acronym / sponsor ID
- OXYGEN / OXYGEN2022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Group Therapy (MBGT+TAU) | Experimental | Behavioral: Mindfulness-based Group TherapyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Group Therapysee above | Behavioural | Mindfulness-based Group Therapy (MBGT+TAU) |
Primary outcome
Change in oxytocin levels
Time frame: Baseline and week 4
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.
Change in empathy levels IRI
Time frame: Baseline and week 4
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.
Change in empathy levels EQ
Time frame: Baseline and week 4
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.
8 secondary outcomes
Change in SMQ Mindfulness
Time frame: Baseline and week 4
PSP Social Functioning
Time frame: Baseline
Change in PANSS Positive, Negative, and General Symptoms
Time frame: Baseline and week 4
Change in SNS Negative Symptoms
Time frame: Baseline and week 4
Change in DASS Depression & Anxiety
Time frame: Baseline and week 4
Change in CFQ Psychological Flexibility
Time frame: Baseline and week 4
Change in PANAS Positive and Negative Affect
Time frame: Baseline and week 4
Change in BIRT Motivation (BMQ)
Time frame: Baseline and week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Group Therapy in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerem Böge, Dr. Dr. ((+49)30 - 450 517636, kerem.boege@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in oxytocin levels (time frame: Baseline and week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.