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

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ClinicalTrials.gov Identifier: NCT04265131
Recruitment Status : Completed
First Posted : February 11, 2020
Last Update Posted : December 23, 2022
Sponsor:
Collaborator:
University Ghent
Information provided by (Responsible Party):
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE December 5, 2019
First Posted Date  ICMJE February 11, 2020
Last Update Posted Date December 23, 2022
Actual Study Start Date  ICMJE October 25, 2019
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2020)
  • Change in Difficulties in Emotion Regulation Outcome Measures [ 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 ]
    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 [ 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 ]
    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. [ 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 ]
    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. [ Time Frame: phase 3 (=9 weeks after baseline outcome measure outcome 1,2 and 3) and phase 4= 3 weeks after phase 3 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome?
Official Title  ICMJE Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome? A Feasibility Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Eating Disorders
  • Anorexia Nervosa
  • Bulimia Nervosa
  • Binge-Eating Disorder
Intervention  ICMJE Other: art therapy
Art therapy is a form of psychotherapy that uses creative methods of expression through art media, such as pencils, clay, paint etc.
Study Arms  ICMJE Experimental: Experimental group
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: Other: art therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2022)		 22
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2020)		 30
Actual Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04265131
Other Study ID Numbers  ICMJE EC/2019/0785
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Ghent
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Ghent
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University Ghent
Investigators  ICMJE Not Provided
PRS Account University Hospital, Ghent
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP