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Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome?

Primary Purpose

Eating Disorders, Anorexia Nervosa, Bulimia Nervosa

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
art therapy
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring art therapy, emotion regulation, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant is diagnosed with an eating disorder by a psychiatrist at the outpatient department of Ghent University Hospital Eating Disorders.
  • At the start of the study, the participant is being treated by a psychiatrist or psychologist at the outpatient department of Eating Disorders at UZ Gent.
  • The participant is informed about the purpose of the research and informed consent.

Exclusion Criteria:

  • The candidate has already had a hospitalization and so art therapy at the eating disorders department at UZ Gent.
  • Lower intelligence with an estimated IQ score lower than 85- The candidate participant is a minor at the start of the study.
  • The candidate is struggling with a psychotic problem, as determined by the treating physician or psychologist.

Sites / Locations

  • Ghent University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

art therapy is delivered on top of treatment as usual (TAU). TAU means that individual verbal therapy takes place on a regular basis, whereby the frequency varies depending on the severity of the eating disorder and the patient's request for help. Cognitive-behavioral therapy is provided with elements of dialectical behavioral therapy, and there is also the possibility of family or couple counseling by a family-based therapist.

Outcomes

Primary Outcome Measures

Change in Difficulties in Emotion Regulation Outcome Measures
Measured with "Difficulties in Emotion Regulation Scale" (DERS). This questionnaire contains 36 items that are surveyed on 6 different subscales for clinically relevant emotion regulation problems. Items are scored on a five-point scale from 1 (almost never) to 5 (almost always).
Change in Cognitive Emotion Regulation
Measured with Cognitive Emotion Regulation Questionnaire (CERQ). This questionnaire with 36 items, in which is assessed what someone thinks in stressful situations.
Change in the the psychological background of the eating disorder.
Measures with Eating disorder inventory-3 (EDI-3). This self-report questionnaire consists of 2 parts. On the one hand a diagnosis list, based on the DSM-5, on the other hand questions regarding the psychological background of eating disorder.
Change in emotion regulation in art therapy.
Measures with "Expression And Emotion Regulation in Art Therapy Scale" (SERATS) This is a short questionnaire with 9 items asking for emotion regulation in art therapy.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2019
Last Updated
December 22, 2022
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04265131
Brief Title
Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome?
Official Title
Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome? A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Eating disorders are difficult to treat. Some forms of treatment have already been found to be effective, nevertheless chronicity is a major problem. For example, both cognitive behavioral therapy and family therapy (FBT; family-based treatment) appear to be effective treatment methods, in which FBT distinguishes itself primarily in its long-term effect. However, eating disorders persist in 20 to 25 percent of cases, only 46 percent of patients with Anorexia Nervosa fully recover and one third only partially improve. Since the mortality rate of this mental disorder is particularly high, it is necessary to keep looking to improve treatment. Because emotion regulation problems play an important role in the cause and maintenance of an eating disorder, more emotion-focused therapies may improve treatment outcome. Dialectical Behavioral Therapy is a treatment that has a strong focus on emotions regulation, but so far only limited evidence has been found for the effectiveness of this type of therapy in eating disorders. Some studies show that art therapy (AT; art therapy) can contribute to a more adaptive regulation of emotions. However, this type of therapy has not been studied in the context of eating disorders yet. AT is an experiential form of therapy in which art techniques and supplies (including drawing, painting, clay, etc.) are used methodically with a therapeutic purpose. The idea that creative expression can perpetuate or improve mental well-being has been accepted worldwide for many years. Despite the long history of practical applications, to date little evidence exist on the effectiveness of this form of treatment. There's growing worldwide interest in scientific research and the emphasis on evidence-based practice (EBP) for this form of treatment. In a recent study, Lock and colleagues compare AT with cognitive remediation therapy (CRT) and the added value of both in a sample of adolescents with anorexia nervosa combines with obsessive-compulsive problems. Both CRT and AT are offered in this study in combination with family based therapy (FBT). The group in which the combination of FBT and AT was offered yielded better results than those in which FBT is combined with CRT. Study hypothesis: the investigators expect that complementing treatment as usual (TAU) with art therapy (AT) will lead to a decrease in emotion regulation problems in patients with an eating disorder in comparison with TAU only, without AT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
Keywords
art therapy, emotion regulation, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The participants are consecutively assigned in two conditions: a within-subjects design. Those from the experimental group receive standard treatment (TAU) with AT as an extra variable. AT is an experiential form of therapy in which art techniques and supplies (including drawing, painting, clay, etc.) are used methodically with a therapeutic purpose. TAU means that individual verbal therapy takes place on a regular basis, whereby the frequency varies depending on the severity of the eating disorder and the patient's request for help. Cognitive-behavioral therapy is provided with elements of dialectical behavioral therapy, and there is also the possibility of family or couple counseling by a family-based therapist. The participants in the control group only receive this standard treatment (TAU), without AT. Waves will be used: a control group will also become an experimental group at a later stage. In this way the investigators can investigate the additional added value of AT.
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
art therapy is delivered on top of treatment as usual (TAU). TAU means that individual verbal therapy takes place on a regular basis, whereby the frequency varies depending on the severity of the eating disorder and the patient's request for help. Cognitive-behavioral therapy is provided with elements of dialectical behavioral therapy, and there is also the possibility of family or couple counseling by a family-based therapist.
Intervention Type
Other
Intervention Name(s)
art therapy
Intervention Description
Art therapy is a form of psychotherapy that uses creative methods of expression through art media, such as pencils, clay, paint etc.
Primary Outcome Measure Information:
Title
Change in Difficulties in Emotion Regulation Outcome Measures
Description
Measured with "Difficulties in Emotion Regulation Scale" (DERS). This questionnaire contains 36 items that are surveyed on 6 different subscales for clinically relevant emotion regulation problems. Items are scored on a five-point scale from 1 (almost never) to 5 (almost always).
Time Frame
The outcome measure will be assessed in phase 1= baseline outcome, phase 2= 6 weeks after baseline , phase 3 = 3 weeks after phase 2, phase 4= 3 weeks after phase 3 and phase 5 = 6 weeks after phase 4
Title
Change in Cognitive Emotion Regulation
Description
Measured with Cognitive Emotion Regulation Questionnaire (CERQ). This questionnaire with 36 items, in which is assessed what someone thinks in stressful situations.
Time Frame
phase 1= baseline outcome, phase 2= 6 weeks after phase 1, phase 3 = 3 weeks after phase 2, phase 4= 3 weeks after phase 3 and phase 5 = 6 weeks after phase 4
Title
Change in the the psychological background of the eating disorder.
Description
Measures with Eating disorder inventory-3 (EDI-3). This self-report questionnaire consists of 2 parts. On the one hand a diagnosis list, based on the DSM-5, on the other hand questions regarding the psychological background of eating disorder.
Time Frame
phase 1= baseline outcome, phase 2= 6 weeks after phase 1, phase 4= 6 weeks after phase 2 and phase 5 = 6 weeks after phase 4
Title
Change in emotion regulation in art therapy.
Description
Measures with "Expression And Emotion Regulation in Art Therapy Scale" (SERATS) This is a short questionnaire with 9 items asking for emotion regulation in art therapy.
Time Frame
phase 3 (=9 weeks after baseline outcome measure outcome 1,2 and 3) and phase 4= 3 weeks after phase 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant is diagnosed with an eating disorder by a psychiatrist at the outpatient department of Ghent University Hospital Eating Disorders. At the start of the study, the participant is being treated by a psychiatrist or psychologist at the outpatient department of Eating Disorders at UZ Gent. The participant is informed about the purpose of the research and informed consent. Exclusion Criteria: The candidate has already had a hospitalization and so art therapy at the eating disorders department at UZ Gent. Lower intelligence with an estimated IQ score lower than 85- The candidate participant is a minor at the start of the study. The candidate is struggling with a psychotic problem, as determined by the treating physician or psychologist.
Facility Information:
Facility Name
Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

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Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome?

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