SchizophreniaNCT03318640
Mindfulness and Cognition in Schizophrenia
A study testing Mindfulness in people with Schizophrenia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Mindfulness (innovative and integrative practice in care) allows the individual to adapt his/her behavior (physical and emotional), in a stressful environment, by regulating cardiac activity, especially the parasympathetic system. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2018to 12 Jul 2021
- 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosis of schizophrenia (men only)
- aged 18-55
- with no change in antipsychotic medication and clinical status within four weeks prior to the study
- affiliates or entitled to a social security scheme
- who have given their informed consent before participating in the study.
Who cannot join
- History of head trauma, neurological disease or not stabilized serious physical illness
- Disorders related to the use of a psychoactive substance, as defined by the DSM-IV (abuse, dependence or withdrawal) within 6 months
- Beta blocking and anti-arrhythmic medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mindfulness (MBSR) on the Parasympathetic System and Cognition in Schizophrenia
Mindfulness (innovative and integrative practice in care) allows the individual to adapt his/her behavior (physical and emotional), in a stressful environment, by regulating cardiac activity, especially the parasympathetic system. In schizophrenia, despite the positive effect of treatments on symptoms (delusions and hallucinations), patients have altered markers of the parasympathetic (high frequency, HF) system. The investigator propose a session of Mindfulness Based Stress Reduction (MBSR) for patients suffering from schizophrenia in order to measure the impact on the parasympathetic system (HF), self-awareness (being well in one's body and being aware of their own actions; EASE) and cognition (attention) in relation to the management of conflicts or emotions. The study compare with patients who receive a session of techniques based on the management of emotions and social cognition (cinemotion, Michael's Game and Tom Remed).
- Conditions
- Schizophrenia
- Being tested
- Mindfulness
- Keywords
- schizophrenia, mindfulness, parasympathetic system
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Patient will have 8 sessions (1h30) of mindfulness based on Kabat-Zinn program during one month
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Patient will have 8 sessions (1h30) of mindfulness based on Kabat-Zinn program during one month. Receives: Behavioral: Mindfulness |
| Control | No intervention | Patient will have usual medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Frequency spectral power
High Frequency spectral power
Measured: 2 months
Secondary outcomes (2)
Score
Score of PANSS (POSITIVE AND NEGATIVE SYNDROME SCALE)
Measured: 2 months
Score
The five facet questionnaire Mindfulness Questionary Freiburg
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start11 Sep 2018
- Primary completion3 May 2021
- Study completion12 Jul 2021
Why it stopped: low inclusion rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between treated group or not
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
- Investigators
- Anne GROSSELIN, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318640
- Sponsor's protocol ID
- 1708181
- Other IDs
- 2017-A02921-52
- Status last verified
- Dec 2023
- First submitted
- 19 Oct 2017
- Last updated
- 18 Dec 2023
- 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 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness (MBSR) on the Parasympathetic System and Cognition in Schizophrenia
- ClinicalTrials.gov ID
- NCT03318640
- Acronym / sponsor ID
- 1708181
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, mindfulness, parasympathetic system
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low inclusion rates
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 24 Oct 2017 (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.
Mindfulness (innovative and integrative practice in care) allows the individual to adapt his/her behavior (physical and emotional), in a stressful environment, by regulating cardiac activity, especially the parasympathetic system. In schizophrenia, despite the positive effect of treatments on symptoms (delusions and hallucinations), patients have altered markers of the parasympathetic (high frequency, HF) system. The investigator propose a session of Mindfulness Based Stress Reduction (MBSR) for patients suffering from schizophrenia in order to measure the impact on the parasympathetic system (HF), self-awareness (being well in one's body and being aware of their own actions; EASE) and cognition (attention) in relation to the management of conflicts or emotions. The study compare with patients who receive a session of techniques based on the management of emotions and social cognition (cinemotion, Michael's Game and Tom Remed).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison between treated group or not
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: MindfulnessPatient will have 8 sessions (1h30) of mindfulness based on Kabat-Zinn program during one month. |
| Control | No intervention | –Patient will have usual medical care. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- DSM-IV diagnosis of schizophrenia (men only)
- aged 18-55
- with no change in antipsychotic medication and clinical status within four weeks prior to the study
- affiliates or entitled to a social security scheme
- who have given their informed consent before participating in the study.
Key exclusion criteria (3 listed)
- History of head trauma, neurological disease or not stabilized serious physical illness
- Disorders related to the use of a psychoactive substance, as defined by the DSM-IV (abuse, dependence or withdrawal) within 6 months
- Beta blocking and anti-arrhythmic medications.
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 |
|---|---|---|
| MindfulnessPatient will have 8 sessions (1h30) of mindfulness based on Kabat-Zinn program during one month | Behavioural | Mindfulness |
Primary outcome
High Frequency spectral power
Time frame: 2 months
High Frequency spectral power
2 secondary outcomes
Score
Time frame: 2 months
Score
Time frame: 2 months
Results and safety
The study was stopped early (reason given: low inclusion rates). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- 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.
Anne GROSSELIN principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 in people with Schizophrenia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 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: stopped early, as of the sponsor's last update on 18 Dec 2023. 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 France. 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?
The study was stopped early (reason given: low inclusion rates). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Frequency spectral power (time frame: 2 months). 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 18 Dec 2023.