SchizophreniaNCT02538445
Can we Forget? Directed Forgetting and Embodied Cognition in Schizophrenia
A study testing Memorization of the verbs by miming the action, Memorization of the verbs by imagining the action and Memorization of the action verbs by means of another word in people with Schizophrenia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Based on the theory of embodied cognition, which focuses on the influence of sensory and motor processes on cognition, researchers propose to study the influence of the action on memorization and inhibition in patients suffering from schizophrenia, using a directed forgetting paradigm. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Memorization of the verbs by miming the action, Memorization of the verbs by imagining the action and Memorization of the action verbs by means of another word
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Dec 2012
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Schizophrenic patients as defined in Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV)
- Stabilized a therapeutic point of view for at least one month.
- Consent form signed
- Affiliated to a Security Health Program
- Consent form signed
- Affiliated to a Security Health Program
Who cannot join
- Not having a history of head trauma, neurological disease or not stabilized serious somatic illness,
- Not to use psychoactive substance, as defined by the DSM IV.
- The Intelligence Quotient must not be less than 70 (Progressive Matrices Standard score (PM38), Raven Progressive Matrix).
Trial locations and contacts
1 site in 1 country.
About this study
Based on the theory of embodied cognition, which focuses on the influence of sensory and motor processes on cognition, researchers propose to study the influence of the action on memorization and inhibition in patients suffering from schizophrenia, using a directed forgetting paradigm. The directed forgetting paradigm is used, composed of two lists of action verbs. The instruction "to forget" is given at the end of learning the first list (To Be Forgotten (TBF)), following a simulation of a computer bug. Therefore a second list is presented to be learned and remembered (To Be Remembered (TBR)). A recognition task is performed at the end. The action verbs had to be encoded using four conditions: action performed, mimed, imagined action, action with a contextual word, reading the action verb only. 48 schizophrenic patients were included in this study. Patients were randomized to have 10 participants per condition. 48 controls matched by age, gender, laterality and education are also included and randomized in the same modality. This study aims to show that the encoding of sensory-motor components, more than providing a context could improve the inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation cognitive.
Read the detailed description
Researchers used the directed forgetting paradigm composed of two lists of action verbs. The instruction "to forget" is given at the end of learning the first list (To Be Forgotten (TBF)), following a simulation of a computer bug. Therefore a second list is presented to be learned and remembered (To Be Remembered (TBR)). A recognition task is performed at the end. The action verbs had to be encoded using four conditions: action performed, mimed, imagined action, action with a contextual word, reading the action verb only. 48 schizophrenic patients were included in this study. Patients were randomized to have 10 participants per condition. 48 controls matched by age, gender, laterality and education are also included and randomized in the same modality. This study aims to show that the encoding of sensory-motor components, more than providing a context could improve the inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation cognitive.
- Conditions
- Schizophrenia
- Being tested
- Memorization of the verbs by miming the action, Memorization of the verbs by imagining the action, Memorization of the action verbs by means of another word, Simple memorization of the verbs
- Keywords
- Schizophrenia, Memory, Cognition
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memorization of the verbs by miming the actionOther
The participant reads aloud the verbs that appear on the screen, by performing the corresponding action verb.
Memorization of the verbs by imagining the actionOther
The participant reads aloud the verbs that appear on the screen, by imagining the corresponding action verb.
Memorization of the action verbs by means of another wordOther
The participant reads aloud the verbs that appear on the screen. Then, he reads, without memorizing it, a word associated with the action verb to be learnt to favor the memorization of that one. The word is written near the action verb.
Simple memorization of the verbsOther
The participant reads aloud the verbs that appear on the screen, without additional instructions (control condition).
| Study group | Role | What they receive |
|---|---|---|
| Patients group 1 | Experimental | Memorization of the verbs by miming the action Receives: Other: Memorization of the verbs by miming the action |
| Patients group 2 | Experimental | Memorization of the verbs by imagining the action Receives: Other: Memorization of the verbs by imagining the action |
| Patients group 3 | Experimental | Memorization of the action verbs by means of another word Receives: Other: Memorization of the action verbs by means of another word |
| Patients group 4 | Experimental | Simple memorization of the verbs Receives: Other: Simple memorization of the verbs |
| Healthy volonteers group 1 | Active comparator | Memorization of the verbs by miming the action Receives: Other: Memorization of the verbs by miming the action |
| Healthy volonteers group 2 | Active comparator | Memorization of the verbs by imagining the action Receives: Other: Memorization of the verbs by imagining the action |
| Healthy volonteers group 3 | Active comparator | Memorization of the action verbs by means of another word Receives: Other: Memorization of the action verbs by means of another word |
| Healthy volonteers group 4 | Active comparator | Simple memorization of the verbs Receives: Other: Simple memorization of the verbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of items recalled TBR and TBF
It is asked to the participants to recall orally, only TBR verbs (task of reminder). The experimenter notes the given verbs.
Measured: Day 1
Secondary outcomes (2)
Number of recognized items
Participants must recognize TBR verbs among several verbs (distractor or TBF verbs) on the screen.The experimenter notes the recognized verbs.
The recognition of a verb in the TBF list or a distractor is considered like an error.
Measured: Day 1
Reaction time (ms) on the recognition of TBR and TBF
The response times of participants are recorded in ms.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne GROSSELIN, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538445
- Sponsor's protocol ID
- 1001156
- Other IDs
- 2010-A01372-37
- Status last verified
- Aug 2015
- First submitted
- 31 Aug 2015
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Forget? Directed Forgetting and Embodied Cognition in Schizophrenia
- ClinicalTrials.gov ID
- NCT02538445
- Acronym / sponsor ID
- 1001156
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Memory, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Sep 2015 (estimated)
- 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.
Based on the theory of embodied cognition, which focuses on the influence of sensory and motor processes on cognition, researchers propose to study the influence of the action on memorization and inhibition in patients suffering from schizophrenia, using a directed forgetting paradigm. The directed forgetting paradigm is used, composed of two lists of action verbs. The instruction "to forget" is given at the end of learning the first list (To Be Forgotten (TBF)), following a simulation of a computer bug. Therefore a second list is presented to be learned and remembered (To Be Remembered (TBR)). A recognition task is performed at the end. The action verbs had to be encoded using four conditions: action performed, mimed, imagined action, action with a contextual word, reading the action verb only. 48 schizophrenic patients were included in this study. Patients were randomized to have 10 participants per condition. 48 controls matched by age, gender, laterality and education are also included and randomized in the same modality. This study aims to show that the encoding of sensory-motor components, more than providing a context could improve the inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation cognitive.
Detailed description
Researchers used the directed forgetting paradigm composed of two lists of action verbs. The instruction "to forget" is given at the end of learning the first list (To Be Forgotten (TBF)), following a simulation of a computer bug. Therefore a second list is presented to be learned and remembered (To Be Remembered (TBR)). A recognition task is performed at the end. The action verbs had to be encoded using four conditions: action performed, mimed, imagined action, action with a contextual word, reading the action verb only. 48 schizophrenic patients were included in this study. Patients were randomized to have 10 participants per condition. 48 controls matched by age, gender, laterality and education are also included and randomized in the same modality. This study aims to show that the encoding of sensory-motor components, more than providing a context could improve the inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation cognitive.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Patients group 1 | Experimental | Other: Memorization of the verbs by miming the actionMemorization of the verbs by miming the action |
| Patients group 2 | Experimental | Other: Memorization of the verbs by imagining the actionMemorization of the verbs by imagining the action |
| Patients group 3 | Experimental | Other: Memorization of the action verbs by means of another wordMemorization of the action verbs by means of another word |
| Patients group 4 | Experimental | Other: Simple memorization of the verbsSimple memorization of the verbs |
| Healthy volonteers group 1 | Active comparator | Other: Memorization of the verbs by miming the actionMemorization of the verbs by miming the action |
| Healthy volonteers group 2 | Active comparator | Other: Memorization of the verbs by imagining the actionMemorization of the verbs by imagining the action |
| Healthy volonteers group 3 | Active comparator | Other: Memorization of the action verbs by means of another wordMemorization of the action verbs by means of another word |
| Healthy volonteers group 4 | Active comparator | Other: Simple memorization of the verbsSimple memorization of the verbs |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Schizophrenic patients as defined in Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV)
- Stabilized a therapeutic point of view for at least one month.
- Consent form signed
- Affiliated to a Security Health Program
- Consent form signed
Key exclusion criteria (3 listed)
- Not having a history of head trauma, neurological disease or not stabilized serious somatic illness,
- Not to use psychoactive substance, as defined by the DSM IV.
- The Intelligence Quotient must not be less than 70 (Progressive Matrices Standard score (PM38), Raven Progressive Matrix).
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 |
|---|---|---|
| Memorization of the verbs by miming the actionThe participant reads aloud the verbs that appear on the screen, by performing the corresponding action verb. | Other | Healthy volonteers group 1, Patients group 1 |
| Memorization of the verbs by imagining the actionThe participant reads aloud the verbs that appear on the screen, by imagining the corresponding action verb. | Other | Healthy volonteers group 2, Patients group 2 |
| Memorization of the action verbs by means of another wordThe participant reads aloud the verbs that appear on the screen. Then, he reads, without memorizing it, a word associated with the action verb to be learnt to favor the memorization of that one. The word is written near the action verb. | Other | Healthy volonteers group 3, Patients group 3 |
| Simple memorization of the verbsThe participant reads aloud the verbs that appear on the screen, without additional instructions (control condition). | Other | Healthy volonteers group 4, Patients group 4 |
Primary outcome
Number of items recalled TBR and TBF
Time frame: Day 1
It is asked to the participants to recall orally, only TBR verbs (task of reminder). The experimenter notes the given verbs.
2 secondary outcomes
Number of recognized items
Time frame: Day 1
Reaction time (ms) on the recognition of TBR and TBF
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- 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, MD principal investigator
CHU 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 Memorization of the verbs by miming the action, Memorization of the verbs by imagining the action and Memorization of the action verbs by means of another word 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 6 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: finished, as of the sponsor's last update on 23 Mar 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of items recalled TBR and TBF (time frame: Day 1). 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 23 Mar 2016.