- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04538846
Culinary Art Therapy Group for Adults With Eating Disorders.
February 21, 2021 updated by: Adi Schleyer, Hadassah Medical Organization
Culinary Art Therapy Group for Adults With Eating Disorders: Assessment of Influence on Thinking, Patterns and Behaviour Related to Food.
The study will assess the influence of culinary art therapy group (a new therapeutic tool) for adults with eating disorders.
It will assess changes in thinking patterns and behavioural patterns associated with food and eating.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jerusalem, Israel
- Eating disorders outpatients department, Hadassah Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A diagnosis of eating disorder
- Body Mass Index (BMI) > 15
Exclusion Criteria:
- No active participation in three group sessions
- Refusal to take an active part in the sessions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Culinary Art Therapy Group
Patients with eating disorders that will participate in a weekly session of culinary art therapy group.
|
Culinary art therapy is a novel approach which broadly perceives food and cooking as enabling participants to explore needs, patterns and relationships and facilitate therapeutic processes.
|
No Intervention: No Culinary Art Therapy Intervention
Patients with eating disorders that are not scheduled to come to the outpatients ward on the day of intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Attitudes Test (EAT-26)
Time Frame: 3 months
|
This is a screening measure to help determine whether a person might have an eating disorder that needs professional attention.
This screening measure is not designed to make a diagnosis of an eating disorder or take the place of a professional consultation.
|
3 months
|
Eating & Meal Preparation Skills Questionnaire (EMPSA)
Time Frame: 3 months
|
The EMPSA is a 12-item self-report assessment tool designed to measure eating disordered clients' perceived ability and motivation to perform 12 eating and meal preparation tasks.
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3 months
|
Rosenberg Self-Esteem Scale (RSES)
Time Frame: 3 months
|
The Rosenberg Self-Esteem Scale (RSES) assesses global self-esteem and sense of self-worthiness.
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Communication and Interaction Skills (ACIS)
Time Frame: 3 months
|
The ACIS is an observational assessment that gathers data on communication and interaction skills.
Three domains, physicality, information exchange, and relations, are used to describe different aspects of communication and interaction.
The ACIS gathers data on skill as it is exhibited during performance in an occupational form and/or within a social group.
|
3 months
|
Individual semi-structured interview
Time Frame: 3 months
|
Interviews aimed to allow each participant to relate to his or her own experience in a more independent and possibly safer setting.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Adi Stern, Dr., University of Haifa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2020
Primary Completion (Anticipated)
September 1, 2021
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
August 31, 2020
First Submitted That Met QC Criteria
August 31, 2020
First Posted (Actual)
September 4, 2020
Study Record Updates
Last Update Posted (Actual)
February 23, 2021
Last Update Submitted That Met QC Criteria
February 21, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0482-20-HMO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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