NCT05861661

Brief Summary

The current research has two goals: first to validate the Hebrew version of a new measurement for assessing mentalization failures. The second goal is to examine the connection between attachment, emotional regulation strategies, mentalization, and specific mentalization failures - As they manifested in anorexia nervosa (AN) compared with non-patient controls. The study includes computer tasks, questionnaires and two short tasks administrated by the examiner.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 12, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2021

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
Last Updated

May 17, 2023

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

July 12, 2020

Last Update Submit

May 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mentalization impairments measured by questionnaire

    one year

Interventions

The study do not include an intervention

Eligibility Criteria

Age16 Years - 28 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsself identification
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Women hospitalized with AN at the ages 16-28.

You may qualify if:

  • All patients will meet the DSM-5 (APA, 2013) criteria for diagnosis of AN on admission.

You may not qualify if:

  • Patients will have no lifetime or current diagnosis of bipolar disorder, schizophrenia spectrum disorder, substance use disorder, mental retardation, organic brain syndrome, and any physical disorder except for inter-current medical problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ziv Hospital

Safed, Galilee, 13100, Israel

Location

Sheba Medical Center

Ramat Gan, 32205, Israel

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2020

First Posted

May 17, 2023

Study Start

July 12, 2020

Primary Completion

July 12, 2021

Study Completion

July 12, 2021

Last Updated

May 17, 2023

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations