Eating DisordersNCT04265131
Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome?
A study testing art therapy in people with Eating Disorders and Anorexia Nervosa, run by University Hospital, Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- art therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Oct 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome? A Feasibility Study
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.
- Being tested
- art therapy
- Keywords
- art therapy, emotion regulation, treatment
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
art therapyOther
Art therapy is a form of psychotherapy that uses creative methods of expression through art media, such as pencils, clay, paint etc.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Other: art therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: phase 3 (=9 weeks after baseline outcome measure outcome 1,2 and 3) and phase 4= 3 weeks after phase 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start25 Oct 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265131
- Sponsor's protocol ID
- EC/2019/0785
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2019
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fairburn CG, Harrison PJ. Eating disorders. Lancet. 2003 Feb 1;361(9355):407-16. doi: 10.1016/S0140-6736(03)12378-1.
PubMed 12573387Juarascio 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.
PubMed 23475153Sharp 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.
PubMed 20844951Couturier 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.
PubMed 22821753Arcelus 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.
PubMed 21727255Davies 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.
PubMed 22431401Svaldi 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.
PubMed 22401969Lattimore 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.
PubMed 27915166Lavender 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.
PubMed 26112760Linardon 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.
PubMed 29089145Haeyen 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.
PubMed 28926306Haeyen 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.
PubMed 28730717van 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.
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.
PubMed 29152825Holmqvist 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.
PubMed 22023072
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome? A Feasibility Study
- ClinicalTrials.gov ID
- NCT04265131
- Acronym / sponsor ID
- EC/2019/0785
- Keywords
- art therapy, emotion regulation, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: art therapyart 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| art therapyArt therapy is a form of psychotherapy that uses creative methods of expression through art media, such as pencils, clay, paint etc. | Other | Experimental group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Background: PubMed 12573387Fairburn CG, Harrison PJ. Eating disorders. Lancet. 2003 Feb 1;361(9355):407-16. doi: 10.1016/S0140-6736(03)12378-1.
- Background: PubMed 23475153Juarascio 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.
- Background: PubMed 20844951Sharp 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.
- Background: PubMed 22821753Couturier 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.
- Background: PubMed 21727255Arcelus 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.
- Background: PubMed 22431401Davies 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.
- Background: PubMed 22401969Svaldi 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.
- Background: PubMed 27915166Lattimore 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.
- Background: PubMed 26112760Lavender 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.
- Background: PubMed 29089145Linardon 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.
- Background: PubMed 28926306Haeyen 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.
- Background: PubMed 28730717Haeyen 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.
Related trials for Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Recruiting
Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
Bulimia Nervosa, Feeding and Eating Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing art therapy in people with Eating Disorders and Anorexia Nervosa, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04265131, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.