Anorexia NervosaNCT02595164
Common Decision Making Deficits in Suicidal Behaviors and Eating Disorders
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by Sheba Medical Center.
Trial summary
The role of impulsivity and its contribution to suicidal behavior seems intuitively clear. Empirical results have proved the existence of a relationship between the two yet many questions are left unanswered, especially what differentiates suicide ideators from attempters.. Read more about this study
- Who is it for?
- Ages 13 to 30 years, women only
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa, Suicide
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2019
- 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 13 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: For our research we will recruit 100 participants from a sample of female patients, diagnosed with Eating Disorders and suicidal behavior, admitted to mental health departments in general and psychiatric hospitals. Diagnosis will be made by the hospital staff. After receiving approval from the medical staff participants will be interviewed, handed questionnaires and computerized tasks.
Who may be able to join
- Psychiatric Diagnosis of Bulimia Nervosa, Anorexia Nervosa
Who cannot join
- BMI < 16
Trial locations and contacts
No sites are listed yet.
Eran Saghiv, MA contact
About this study
The role of impulsivity and its contribution to suicidal behavior seems intuitively clear. Empirical results have proved the existence of a relationship between the two yet many questions are left unanswered, especially what differentiates suicide ideators from attempters.. Obsessive thinking patterns are thought processes which share a repetitive behavior domain and are exerted by an inner voice. 3 types of obsessive thinking patterns are self destructive thoughts, ruminations and overvalued ideas. Impulsivity and obsessive thinking patterns are presumed to have a common mechanism of behaviors which are resulted from basal ganglia dysregulation and thus effect inhibition. Novel research in the field of decision making could help to learn more about behavioral patterns associated with self harm behavior and suicide. Eating Disorders involve suicidal and self harm behavior, which both feature impulsivity and obsessive thinking patterns. The investigators study proposes a 3-step theoretical model which asserts there is a connection between impulsivity, obsessive thinking and poor decision making, all effecting self harm behavior. Contemporary research has not been able to fully understand the nature of impulsivity and its effect on self harm behavior, including eating disorders symptoms, nor addressed the impact of obsessive thinking patterns on the latter. 100 female participants with Eating Disorders and suicidal behavior will be recruited for the proposed research. Subjects will be given self-report questionnaires and computerized behavioral tasks. A one way ANOVA of two eating disorder subgroups, impulsive and non impulsive, will be conducted, following a hierarchical multiple regression with self harm behavior being the dependent variable.
Read the detailed description
Aim of Study impulsivity and its relation to different self harm behaviors, specifically suicidal attempts, is an ongoing field of study which has already been widely discussed. Yet to this date, the relationship remains unclear and somewhat confusing. Possible explanations for this might be due to the fact that impulsivity is an ill-defined concept leading to numerous definitions used by different studies and the fact that it has a trait and state aspect to it. Clinical experience and theory leads to the assumption that impulsivity plays a very important role in suicide. Novel research in the field of decision making could possibly lead to a breakthrough in improving assessment and prevention of suicide attempts and learning more of this complex relationship.
The study of obsessive thinking patterns and their contribution to suicide is less prominent. In spite of the lack of magnitude in research, when looking at underlying mechanisms it is noticeable that both impulsivity and obsessive thinking share common factors and are congruent in many ways. Determining more about the nature of different obsessive thinking patterns such as self destructive thoughts, rumination and over-valued ideas manifested by an inner voice is crucial from two points of view: on one hand learning more about the relation between the different patterns, and their mutual and independent effect on self harm behavior. On the other hand, observing them as complementing factors to impulsivity which may lead to a better understanding of the latter. Studying the interaction between trait impulsivity and different obsessive thinking patterns could lead to a better understanding of the theoretical gap discussed in the literature review between suicidal ideators and attempters.
Literature has proven that observing behavioral patterns in decision making tasks could serve as a better predictor to self harm and suicidal behavior, compared to solely relying on self report. The investigators intention is to try and find correlations between the personality dimensions of impulsivity and obsessive thinking and specific behavioral patterns indicating suicidal and self harm behavior. Understanding more on impulsive and obsessive thinking patterns and their effect on self harm behaviors in "real life" situations can raise the ecological validity and aid in exporting research conclusions to a clinical setting.
The investigators research will recruit a population which is known to feature both impulsivity and obsessive thinking patterns, such as in Eating Disorders, where their co-existence has been proven empirically yet the nature of the interaction is not fully understood. Eating disorder individuals are also at higher risk of attempting suicide and exhibiting self harm behaviors in general compared to a non clinical population, making it a relevant group to the proposed study.
The investigators propose that impulsive behavior and obsessive thinking patterns have a negative effect on performance in decision making situations. When there is a tendency to make bad decisions the risk of executing different forms of self harm rises, including suicidal behavior and eating disorders.
Method:
Participants The investigators will recruit 100 participants from a sample of female patients, diagnosed with Eating Disorders and suicidal behavior, admitted to mental health departments in general and psychiatric hospitals. Diagnosis will be made by the hospital staff. After receiving approval from the medical staff participants will be interviewed, handed questionnaires and computerized tasks.
Procedure Research will consist of two parts: at first investigators will conduct a preliminary research on 20 subjects which is intended to decrease questionnaire bandwidth. Analysis of items administered and correlations will indicate on unsuitable and congruent items which will be removed from research. In the second part of the study 100 female participants will be nominated for research. Participants will be briefed about the research rationale and procedure and instructed to sign an informed consent (parents of minors will be briefed and instructed to sign as well) indicating on their willingness to participate. Following this participants will be administered interviews, self report questionnaires and computerized tasks by the research team. It will be clarified to participants that questionnaires are anonymous and there are no wrong or right answers. Participants that are not able to handle research demands due to their physical condition will be interviewed by the research team in accordance with the nature of the questionnaire.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa, Suicide, Parasuicide, Self-Injurious Behavior, Impulsive Behavior
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa, Suicide, Suicide, Attempted, Self-Injurious Behavior, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Impulsive subjects | Subjects exhibiting impulsive symptoms Behavioral Task | |
| Non-impulsive subjects | Subjects which do not exhibit impulsive symptoms Behavioral Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
impulsive tendency
computerized tasks
Measured: throughout study completion, approximately 1 year
Secondary outcomes (1)
impulsivity self report
questionnaires
Measured: throughout study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Schneider Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Yari Gvion, DR, Study director, Bar Ilan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595164
- Sponsor's protocol ID
- SHEBA-15-2191-EGA-CTIL
- Status last verified
- Nov 2015
- First submitted
- 19 Jul 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Decision Making Deficits in Suicidal Behaviors and Eating Disorders
- ClinicalTrials.gov ID
- NCT02595164
- Acronym / sponsor ID
- SHEBA-15-2191-EGA-CTIL
- Conditions
- Anorexia Nervosa, Bulimia Nervosa, Suicide, Parasuicide, Self-Injurious Behavior, Impulsive Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Schneider Children's Hospital
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 3 Nov 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.
The role of impulsivity and its contribution to suicidal behavior seems intuitively clear. Empirical results have proved the existence of a relationship between the two yet many questions are left unanswered, especially what differentiates suicide ideators from attempters.. Obsessive thinking patterns are thought processes which share a repetitive behavior domain and are exerted by an inner voice. 3 types of obsessive thinking patterns are self destructive thoughts, ruminations and overvalued ideas. Impulsivity and obsessive thinking patterns are presumed to have a common mechanism of behaviors which are resulted from basal ganglia dysregulation and thus effect inhibition. Novel research in the field of decision making could help to learn more about behavioral patterns associated with self harm behavior and suicide. Eating Disorders involve suicidal and self harm behavior, which both feature impulsivity and obsessive thinking patterns. The investigators study proposes a 3-step theoretical model which asserts there is a connection between impulsivity, obsessive thinking and poor decision making, all effecting self harm behavior. Contemporary research has not been able to fully understand the nature of impulsivity and its effect on self harm behavior, including eating disorders symptoms, nor addressed the impact of obsessive thinking patterns on the latter. 100 female participants with Eating Disorders and suicidal behavior will be recruited for the proposed research. Subjects will be given self-report questionnaires and computerized behavioral tasks. A one way ANOVA of two eating disorder subgroups, impulsive and non impulsive, will be conducted, following a hierarchical multiple regression with self harm behavior being the dependent variable.
Detailed description
Aim of Study impulsivity and its relation to different self harm behaviors, specifically suicidal attempts, is an ongoing field of study which has already been widely discussed. Yet to this date, the relationship remains unclear and somewhat confusing. Possible explanations for this might be due to the fact that impulsivity is an ill-defined concept leading to numerous definitions used by different studies and the fact that it has a trait and state aspect to it. Clinical experience and theory leads to the assumption that impulsivity plays a very important role in suicide. Novel research in the field of decision making could possibly lead to a breakthrough in improving assessment and prevention of suicide attempts and learning more of this complex relationship.
The study of obsessive thinking patterns and their contribution to suicide is less prominent. In spite of the lack of magnitude in research, when looking at underlying mechanisms it is noticeable that both impulsivity and obsessive thinking share common factors and are congruent in many ways. Determining more about the nature of different obsessive thinking patterns such as self destructive thoughts, rumination and over-valued ideas manifested by an inner voice is crucial from two points of view: on one hand learning more about the relation between the different patterns, and their mutual and independent effect on self harm behavior. On the other hand, observing them as complementing factors to impulsivity which may lead to a better understanding of the latter. Studying the interaction between trait impulsivity and different obsessive thinking patterns could lead to a better understanding of the theoretical gap discussed in the literature review between suicidal ideators and attempters.
Literature has proven that observing behavioral patterns in decision making tasks could serve as a better predictor to self harm and suicidal behavior, compared to solely relying on self report. The investigators intention is to try and find correlations between the personality dimensions of impulsivity and obsessive thinking and specific behavioral patterns indicating suicidal and self harm behavior. Understanding more on impulsive and obsessive thinking patterns and their effect on self harm behaviors in "real life" situations can raise the ecological validity and aid in exporting research conclusions to a clinical setting.
The investigators research will recruit a population which is known to feature both impulsivity and obsessive thinking patterns, such as in Eating Disorders, where their co-existence has been proven empirically yet the nature of the interaction is not fully understood. Eating disorder individuals are also at higher risk of attempting suicide and exhibiting self harm behaviors in general compared to a non clinical population, making it a relevant group to the proposed study.
The investigators propose that impulsive behavior and obsessive thinking patterns have a negative effect on performance in decision making situations. When there is a tendency to make bad decisions the risk of executing different forms of self harm rises, including suicidal behavior and eating disorders.
Method:
Participants The investigators will recruit 100 participants from a sample of female patients, diagnosed with Eating Disorders and suicidal behavior, admitted to mental health departments in general and psychiatric hospitals. Diagnosis will be made by the hospital staff. After receiving approval from the medical staff participants will be interviewed, handed questionnaires and computerized tasks.
Procedure Research will consist of two parts: at first investigators will conduct a preliminary research on 20 subjects which is intended to decrease questionnaire bandwidth. Analysis of items administered and correlations will indicate on unsuitable and congruent items which will be removed from research. In the second part of the study 100 female participants will be nominated for research. Participants will be briefed about the research rationale and procedure and instructed to sign an informed consent (parents of minors will be briefed and instructed to sign as well) indicating on their willingness to participate. Following this participants will be administered interviews, self report questionnaires and computerized tasks by the research team. It will be clarified to participants that questionnaires are anonymous and there are no wrong or right answers. Participants that are not able to handle research demands due to their physical condition will be interviewed by the research team in accordance with the nature of the questionnaire.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impulsive subjects | – | –Subjects exhibiting impulsive symptoms Behavioral Task |
| Non-impulsive subjects | – | –Subjects which do not exhibit impulsive symptoms Behavioral Task |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- For our research we will recruit 100 participants from a sample of female patients, diagnosed with Eating Disorders and suicidal behavior, admitted to mental health departments in general and psychiatric hospitals. Diagnosis will be made by the hospital staff. After receiving approval from the medical staff participants will be interviewed, handed questionnaires and computerized tasks.
Key inclusion criteria (1 listed)
- Psychiatric Diagnosis of Bulimia Nervosa, Anorexia Nervosa
Key exclusion criteria (1 listed)
- BMI < 16
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
impulsive tendency
Time frame: throughout study completion, approximately 1 year
computerized tasks
1 secondary outcome
impulsivity self report
Time frame: throughout study completion, approximately 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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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.
Eran Saghiv, MA contact
Yari Gvion, DR study director
Bar Ilan University
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by Sheba Medical Center.
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 1 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Eitan Gur, MD (+972-3-5305105, eitan.gur@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impulsive tendency (time frame: throughout study completion, approximately 1 year). 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 3 Nov 2015.