CBT-Eb Plus EMDR Versus CBT-Eb in Patients With Eating Disorders

NCT03156959 | Unknown

• 1 other identifier: 1153CESC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Enhanced CBT (CBT-E) is an effective treatment for the majority of outpatients with an eating disorder; however in about 30% of patients remission is made difficult. This may be due to the concomitant presence of trauma. Therefore we expect that a combination of CBT-E and EMDR, which is the evidence based treatment for PTSD disorder, would enhance the remission probability. This trial has a parallel group randomized controlled design. All patients who will enter in contact with the Regional Reference Centre for Eating Disorders in Verona and will satisfy inclusion criteria will be randomized to the broad form of CBT-E (CBT-Eb) plus EMDR or CBT-Eb alone. Patients will be evaluated before the treatment, at the end of treatment and after 6 months post-treatment with a set of standardized measure to assess eating disorder symptoms and other possible predisposing and moderating factors. The efficacy of CBT-E vs CBT-E + EMDR will be evaluated at the end of the treatment and after 6 months in terms of global score of the Eating Disorder Examination. Moreover the changes in other secondary outcomes will be considered. This explorative study may suggest new hypothesis for larger RCTs in order to increase the knowledge on ED.

Conditions

Eating Disorder

Keywords

Eating disorders; Cognitive Behavioral Therapy; Eye Movement Desensitization and Processing

Outcome Measures

Primary Outcomes (2)

• Changes in Severity of the Eating Disorder

  Global score of the Eating Disorder Examination (EDE)

  From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5)

• Changes in Severity of the Eating Disorder

  Global score of the Eating Disorder Examination (EDE)

  From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1)

Secondary Outcomes (28)

• Changes in Psychopathological conditions

  From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5)

• Changes in Psychopathological conditions

  From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1)

• Changes in the Number of patients "in remission" for general psychopathology

  From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5)

• Changes in the Number of patients "in remission" for general psychopathology

  From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1)

• Changes in Eating disorder risk factors

  From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5)

Study Arms (2)

EMDR plus CBT-Eb

EXPERIMENTAL

20 CBT-Eb sessions will be mandatory for patients with BMI\>17.5 and 40 CBT-Eb sessions will be mandatory for patients with BMI≤17.5. In the EMDR plus CBT-Eb arm, 16 EMDR sessions will be mandatory in adjunction to the CBT-Eb sessions, irrespectively of the BMI. EMDR will use an eight-phase approach that will include having the patient recall distressing images while receiving one of several types of bilateral sensory input, such as side to side eye movements. Patients will follow psychopharmacological treatment for anxiety and depression symptoms if needed, and their parents will be invited to participate to a cycle of eight family meetings on eating disorders and psychological support following ECHO approach (Rhind et al., 2014).

Behavioral: EMDR; Behavioral: CBT-Eb

CBT-Eb alone

ACTIVE COMPARATOR

20 CBT-Eb sessions will be mandatory for patients with BMI\>17.5 and 40 CBT-Eb sessions will be mandatory for patients with BMI≤17.5. Patients will follow psychopharmacological treatment for anxiety and depression symptoms if needed, and their parents will be invited to participate to a cycle of eight family meetings on eating disorders and psychological support following ECHO approach (Rhind et al., 2014).

Behavioral: CBT-Eb

Interventions

EMDR BEHAVIORAL

The Eye Movement Desensitization and Reprocessing (EMDR) is a psychotherapy developed by Francine Shapiro (2001) that emphasizes disturbing memories as the cause of psychopathology. These memories and associated stimuli are inadequately processed and stored in an isolated memory network (Shapiro and Laliotis, 2010). The goal of EMDR is to reduce the long-lasting effects of distressing memories by developing more adaptive coping mechanisms.

EMDR plus CBT-Eb

CBT-Eb BEHAVIORAL

The broad form of Enhanced Cognitive Behavioural Therapy (CBT-Eb; Fairburn and colleagues, 2009) addresses psychopathological processes "external" to the eating disorder, such as clinical perfectionism, low self-esteem or interpersonal difficulties, which interact with the disorder itself.

CBT-Eb alone; EMDR plus CBT-Eb

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 14 and 45 years
• Diagnosis of Eating Disorder that meets DSM 5 diagnostic criteria for Anorexia Nervosa (AN), Bulimia Nervosa (BN) or Other Specified Feeding or Eating Disorder (OSFED)
• A clinical severity which permits to treat the person at out-patient level

You may not qualify if:

• Eating Disorder of high clinical severity, not treatable at out-patient level
• Comorbidity with psychotic symptoms or any other DSM 5 disorder which might hinder eating disorder treatment
• Medical conditions which might impede data interpretation (chemotherapy, pregnancy status)
• Substances use and abuse
• Having previously received an evidence-based CBT treatment for the same eating disorder and/or EMDR

Sponsors & Collaborators

• Ruggeri, Mirella: lead

Study Sites (1)

Regional Reference Centre For Eating Disorders of Verona

Verona, 37134, Italy

RECRUITING

Related Publications (22)

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  PMID: 9097195 BACKGROUND

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  PMID: 20599136 BACKGROUND

• Fairburn CG, Jones R, Peveler RC, Hope RA, O'Connor M. Psychotherapy and bulimia nervosa. Longer-term effects of interpersonal psychotherapy, behavior therapy, and cognitive behavior therapy. Arch Gen Psychiatry. 1993 Jun;50(6):419-28. doi: 10.1001/archpsyc.1993.01820180009001.

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• Fairburn CG, Cooper Z, Doll HA, O'Connor ME, Bohn K, Hawker DM, Wales JA, Palmer RL. Transdiagnostic cognitive-behavioral therapy for patients with eating disorders: a two-site trial with 60-week follow-up. Am J Psychiatry. 2009 Mar;166(3):311-9. doi: 10.1176/appi.ajp.2008.08040608. Epub 2008 Dec 15.

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  PMID: 8750449 BACKGROUND

• Grilo CM, Masheb RM. Childhood maltreatment and personality disorders in adult patients with binge eating disorder. Acta Psychiatr Scand. 2002 Sep;106(3):183-8. doi: 10.1034/j.1600-0447.2002.02303.x.

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  PMID: 10065393 BACKGROUND

• Mahon J, Bradley SN, Harvey PK, Winston AP, Palmer RL. Childhood trauma has dose-effect relationship with dropping out from psychotherapeutic treatment for bulimia nervosa: a replication. Int J Eat Disord. 2001 Sep;30(2):138-48. doi: 10.1002/eat.1066.

  PMID: 11449447 BACKGROUND

• Reyes-Rodriguez ML, Von Holle A, Ulman TF, Thornton LM, Klump KL, Brandt H, Crawford S, Fichter MM, Halmi KA, Huber T, Johnson C, Jones I, Kaplan AS, Mitchell JE, Strober M, Treasure J, Woodside DB, Berrettini WH, Kaye WH, Bulik CM. Posttraumatic stress disorder in anorexia nervosa. Psychosom Med. 2011 Jul-Aug;73(6):491-7. doi: 10.1097/PSY.0b013e31822232bb. Epub 2011 Jun 28.

  PMID: 21715295 BACKGROUND

• Rorty M, Yager J, Rossotto E. Childhood sexual, physical, and psychological abuse and their relationship to comorbid psychopathology in bulimia nervosa. Int J Eat Disord. 1994 Dec;16(4):317-34. doi: 10.1002/1098-108x(199412)16:43.0.co;2-j.

  PMID: 7866412 BACKGROUND

• Rothbaum BO, Astin MC, Marsteller F. Prolonged Exposure versus Eye Movement Desensitization and Reprocessing (EMDR) for PTSD rape victims. J Trauma Stress. 2005 Dec;18(6):607-16. doi: 10.1002/jts.20069.

  PMID: 16382428 BACKGROUND

• Shapiro F, Maxfield L. Eye Movement Desensitization and Reprocessing (EMDR): information processing in the treatment of trauma. J Clin Psychol. 2002 Aug;58(8):933-46. doi: 10.1002/jclp.10068.

  PMID: 12115716 BACKGROUND

• Striegel-Moore RH, Dohm FA, Pike KM, Wilfley DE, Fairburn CG. Abuse, bullying, and discrimination as risk factors for binge eating disorder. Am J Psychiatry. 2002 Nov;159(11):1902-7. doi: 10.1176/appi.ajp.159.11.1902.

  PMID: 12411226 BACKGROUND

• Tagay S, Schlottbohm E, Reyes-Rodriguez ML, Repic N, Senf W. Eating disorders, trauma, PTSD, and psychosocial resources. Eat Disord. 2014;22(1):33-49. doi: 10.1080/10640266.2014.857517.

  PMID: 24365526 BACKGROUND

• van der Kolk BA, Spinazzola J, Blaustein ME, Hopper JW, Hopper EK, Korn DL, Simpson WB. A randomized clinical trial of eye movement desensitization and reprocessing (EMDR), fluoxetine, and pill placebo in the treatment of posttraumatic stress disorder: treatment effects and long-term maintenance. J Clin Psychiatry. 2007 Jan;68(1):37-46. doi: 10.4088/jcp.v68n0105.

  PMID: 17284128 BACKGROUND

• Wonderlich S, Mitchell JE. The role of personality in the onset of eating disorders and treatment implications. Psychiatr Clin North Am. 2001 Jun;24(2):249-58. doi: 10.1016/s0193-953x(05)70221-5.

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• Wonderlich SA, Mitchell JE. Eating disorders and comorbidity: empirical, conceptual, and clinical implications. Psychopharmacol Bull. 1997;33(3):381-90.

  PMID: 9550882 BACKGROUND

• Wonderlich SA, Brewerton TD, Jocic Z, Dansky BS, Abbott DW. Relationship of childhood sexual abuse and eating disorders. J Am Acad Child Adolesc Psychiatry. 1997 Aug;36(8):1107-15. doi: 10.1097/00004583-199708000-00018.

  PMID: 9256590 BACKGROUND

• Wonderlich SA, Crosby RD, Mitchell JE, Thompson KM, Redlin J, Demuth G, Smyth J, Haseltine B. Eating disturbance and sexual trauma in childhood and adulthood. Int J Eat Disord. 2001 Dec;30(4):401-12. doi: 10.1002/eat.1101.

  PMID: 11746301 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mirella Ruggeri, Prof

  University of Verona, Section of Psychiatry

  STUDY CHAIR

Central Study Contacts

Mirella Ruggeri, Prof

CONTACT

+39 045 8127482; mirella.ruggeri@univr.it

Rosa Bruna Dall'Agnola, Dr

CONTACT

+39 045 8124952; rosa.dallagnola@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor in Psychiatry

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 17, 2017
• Study Start: June 19, 2017
• Primary Completion: May 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)