- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02595164
Common Decision Making Deficits in Suicidal Behaviors and Eating Disorders
Study Overview
Status
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Eitan Gur, MD
- Phone Number: +972-3-5305105
- Email: eitan.gur@sheba.health.gov.il
Study Contact Backup
- Name: Eran Saghiv, MA
- Phone Number: +972544860871
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Psychiatric Diagnosis of Bulimia Nervosa, Anorexia Nervosa
Exclusion Criteria:
- BMI < 16
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Impulsive subjects
Subjects exhibiting impulsive symptoms Behavioral Task
|
Non-impulsive subjects
Subjects which do not exhibit impulsive symptoms Behavioral Task
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
impulsive tendency
Time Frame: throughout study completion, approximately 1 year
|
computerized tasks
|
throughout study completion, approximately 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
impulsivity self report
Time Frame: throughout study completion, approximately 1 year
|
questionnaires
|
throughout study completion, approximately 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Yari Gvion, DR, Bar Ilan University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-15-2191-EGA-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anorexia Nervosa
-
Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Fundació La Marató de TV3RecruitingAnorexia Nervosa | Anorexia Nervosa in Remission | Anorexia Nervosa Restricting TypeSpain
-
Duke UniversityCompletedAdolescent Anorexia Nervosa | Subthreshold Anorexia NervosaUnited States
-
Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH) and other collaboratorsCompletedAnorexia Nervosa | Anorexia | Eating Disorder | Eating Disorders in Adolescence | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa Restricting Type | Anorexia in ChildrenUnited States
-
University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
-
Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
-
Umeå UniversityActive, not recruitingAnorexia Nervosa | Anorexia in Adolescence | Anorexia Nervosa, AtypicalSweden
-
Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
-
The Miriam HospitalUnknownEating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia Nervosa Restricting TypeUnited States
-
University Hospital, AkershusRådgivning om SpiseforstyrrelserEnrolling by invitationAnorexia Nervosa | Atypical Anorexia NervosaNorway