AlexithymiaALEXNCT00830752
Neurobiological, Neuropsychological,Linguistic and Gestural Processes and Phenomena in Individuals With Alexithymia
An observational study of Alexithymia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The syndrome of extremely restricted emotional competence, alexithymia, was originally conceptualized in psychoanalytic research and is now empirically and experimentally studied in clinical psychology and psychological medicine within the context of emotion regulation using neuroscientific techniques. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alexithymia
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Dec 2009
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 70 individuals between the ages of 18 and 60 years, both genders, who score high on an alexithymia questionaire (TAS-20) and who are otherwise emotionally and physically healthy. Individuals are sampled via newspaper and poster advertisements throughout the greater metropolitan area of Berlin, Germany
Who may be able to join
- scoring high on the TAS-20
Who cannot join
- personal history of a mental disorder
- currently mentally ill
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite-Dept. of Psychiatry-Campus Benjamin Franklin
Berlin, 14050
Isabella JE Heuser, MD, PhD, ++493084458701, isabella.heuser@charite.de
Claudia Crayen, MS, ++493083857839, claudia.crayen@fu-berlin.de
About this study
Official title: Understanding Alexithymia
The syndrome of extremely restricted emotional competence, alexithymia, was originally conceptualized in psychoanalytic research and is now empirically and experimentally studied in clinical psychology and psychological medicine within the context of emotion regulation using neuroscientific techniques. Alexithymia refers to an individual's inability or impaired ability to name or express feelings and to distinguish them from the physical consequences of an acute or chronic stress reaction. Modern "brain-body-interface" research suggests that alexithymia represents a complex deficiency in cognitive processing and emotional regulatory processes. The neurobiological basis is assumed to be a preconscious, automatic and involuntary information transfer to the amygdalae of acquired representations of emotional contents stored in ventromedial prefrontal cortical areas.
Alexithymia is not just "emotional coldness", i.e. a limited emotionality, but essentially the detachment of feelings from language. In alexithymia the link between affective phenomena and language, understood as media-supported sign practices, is insufficient or even absent.
The purpose of our observational study is to better understand the neurobiological and neuropsychological as well as linguistic and gestural processes and determinants of this phenomenon
- Conditions
- Alexithymia
- Keywords
- alexithymia
- Medical subject headings
- Affective Symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlexithymiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830752
- Sponsor's protocol ID
- ALEX 2009
- Acronym
- ALEX
- Status last verified
- Jan 2009
- First submitted
- 27 Jan 2009
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Alexithymia
- ClinicalTrials.gov ID
- NCT00830752
- Acronym / sponsor ID
- ALEX / ALEX 2009
- Conditions
- Alexithymia
- Keywords
- alexithymia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 28 Jan 2009 (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.
The syndrome of extremely restricted emotional competence, alexithymia, was originally conceptualized in psychoanalytic research and is now empirically and experimentally studied in clinical psychology and psychological medicine within the context of emotion regulation using neuroscientific techniques. Alexithymia refers to an individual's inability or impaired ability to name or express feelings and to distinguish them from the physical consequences of an acute or chronic stress reaction. Modern "brain-body-interface" research suggests that alexithymia represents a complex deficiency in cognitive processing and emotional regulatory processes. The neurobiological basis is assumed to be a preconscious, automatic and involuntary information transfer to the amygdalae of acquired representations of emotional contents stored in ventromedial prefrontal cortical areas.
Alexithymia is not just "emotional coldness", i.e. a limited emotionality, but essentially the detachment of feelings from language. In alexithymia the link between affective phenomena and language, understood as media-supported sign practices, is insufficient or even absent.
The purpose of our observational study is to better understand the neurobiological and neuropsychological as well as linguistic and gestural processes and determinants of this phenomenon
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 70 individuals between the ages of 18 and 60 years, both genders, who score high on an alexithymia questionaire (TAS-20) and who are otherwise emotionally and physically healthy. Individuals are sampled via newspaper and poster advertisements throughout the greater metropolitan area of Berlin, Germany
Key inclusion criteria (1 listed)
- scoring high on the TAS-20
Key exclusion criteria (2 listed)
- personal history of a mental disorder
- currently mentally ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
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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.
Charite-Dept. of Psychiatry-Campus Benjamin Franklin
Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alexithymia, 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 1 inclusion and 2 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 28 Jan 2009. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 28 Jan 2009.