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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04265131
Other study ID # EC/2019/0785
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2019
Est. completion date June 30, 2021

Study information

Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Belgium Ghent University Ghent

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Ghent University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (22)

Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74. — View Citation

Couturier J, Kimber M, Szatmari P. Efficacy of family-based treatment for adolescents with eating disorders: a systematic review and meta-analysis. Int J Eat Disord. 2013 Jan;46(1):3-11. doi: 10.1002/eat.22042. Epub 2012 Jul 23. — View Citation

Davies H, Fox J, Naumann U, Treasure J, Schmidt U, Tchanturia K. Cognitive remediation and emotion skills training for anorexia nervosa: an observational study using neuropsychological outcomes. Eur Eat Disord Rev. 2012 May;20(3):211-7. doi: 10.1002/erv.2170. Epub 2012 Mar 20. — View Citation

Fairburn CG, Harrison PJ. Eating disorders. Lancet. 2003 Feb 1;361(9355):407-16. doi: 10.1016/S0140-6736(03)12378-1. — View Citation

Garnefski, N., & Kraaij, V. (2007). The cognitive emotion regulation questionnaire. European Journal of Psychological Assessment, 23(3), 141-149.

Garner, D. M. (2004). Eating disorder inventory-3 (EDI-3). Professional manual. Odessa, FL: Psychological Assessment Resources.

Gatta, M., Gallo, C., & Vianello, M. (2014). Art therapy groups for adolescents with personality disorders. The Arts in Psychotherapy, 41(1), 1-6.

Gratz, K. L., & Roemer, L. (2004). Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54

Haeyen S, van Hooren S, van der Veld W, Hutschemaekers G. Efficacy of Art Therapy in Individuals With Personality Disorders Cluster B/C: A Randomized Controlled Trial. J Pers Disord. 2018 Aug;32(4):527-542. doi: 10.1521/pedi_2017_31_312. Epub 2017 Sep 19. — View Citation

Haeyen S, van Hooren S, van der Veld WM, Hutschemaekers G. Measuring the contribution of art therapy in multidisciplinary treatment of personality disorders: The construction of the Self-expression and Emotion Regulation in Art Therapy Scale (SERATS). Personal Ment Health. 2018 Feb;12(1):3-14. doi: 10.1002/pmh.1379. Epub 2017 Jul 21. — View Citation

Holmqvist G, Lundqvist Persson C. Is there evidence for the use of art therapy in treatment of psychosomatic disorders, eating disorders and crisis? A comparative study of two different systems for evaluation. Scand J Psychol. 2012 Feb;53(1):47-53. doi: 10.1111/j.1467-9450.2011.00923.x. Epub 2011 Oct 25. — View Citation

Juarascio A, Shaw J, Forman E, Timko CA, Herbert J, Butryn M, Bunnell D, Matteucci A, Lowe M. Acceptance and commitment therapy as a novel treatment for eating disorders: an initial test of efficacy and mediation. Behav Modif. 2013 Jul;37(4):459-89. doi: 10.1177/0145445513478633. Epub 2013 Mar 8. — View Citation

Lattimore P, Mead BR, Irwin L, Grice L, Carson R, Malinowski P. 'I can't accept that feeling': Relationships between interoceptive awareness, mindfulness and eating disorder symptoms in females with, and at-risk of an eating disorder. Psychiatry Res. 2017 Jan;247:163-171. doi: 10.1016/j.psychres.2016.11.022. Epub 2016 Nov 16. — View Citation

Lavender JM, Wonderlich SA, Engel SG, Gordon KH, Kaye WH, Mitchell JE. Dimensions of emotion dysregulation in anorexia nervosa and bulimia nervosa: A conceptual review of the empirical literature. Clin Psychol Rev. 2015 Aug;40:111-22. doi: 10.1016/j.cpr.2015.05.010. Epub 2015 Jun 6. — View Citation

Linardon J, Fairburn CG, Fitzsimmons-Craft EE, Wilfley DE, Brennan L. The empirical status of the third-wave behaviour therapies for the treatment of eating disorders: A systematic review. Clin Psychol Rev. 2017 Dec;58:125-140. doi: 10.1016/j.cpr.2017.10.005. Epub 2017 Oct 23. — View Citation

Lock J, Fitzpatrick KK, Agras WS, Weinbach N, Jo B. Feasibility Study Combining Art Therapy or Cognitive Remediation Therapy with Family-based Treatment for Adolescent Anorexia Nervosa. Eur Eat Disord Rev. 2018 Jan;26(1):62-68. doi: 10.1002/erv.2571. Epub 2017 Nov 20. — View Citation

Sharp WG, Jaquess DL, Morton JF, Herzinger CV. Pediatric feeding disorders: a quantitative synthesis of treatment outcomes. Clin Child Fam Psychol Rev. 2010 Dec;13(4):348-65. doi: 10.1007/s10567-010-0079-7. — View Citation

Slayton, S. C., D'Archer, J., & Kaplan, F. (2010). Outcome studies on the efficacy of art therapy: A review of findings. Art therapy, 27(3), 108-118.

Stuckey HL, Nobel J. The connection between art, healing, and public health: a review of current literature. Am J Public Health. 2010 Feb;100(2):254-63. doi: 10.2105/AJPH.2008.156497. Epub 2009 Dec 17. — View Citation

Svaldi J, Griepenstroh J, Tuschen-Caffier B, Ehring T. Emotion regulation deficits in eating disorders: a marker of eating pathology or general psychopathology? Psychiatry Res. 2012 May 15;197(1-2):103-11. doi: 10.1016/j.psychres.2011.11.009. Epub 2012 Mar 7. — View Citation

van den Broek, E., Keulen-de Vos, M., & Bernstein, D. P. (2011). Arts therapies and schema focused therapy: A pilot study. The Arts in Psychotherapy, 38(5), 325-332.

Van Lith, T. (2016). Art therapy in mental health: A systematic review of approaches and practices. The Arts in Psychotherapy, 47, 9-22.

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 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
Primary 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. 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
Primary 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. 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
Primary 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. phase 3 (=9 weeks after baseline outcome measure outcome 1,2 and 3) and phase 4= 3 weeks after phase 3
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