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Trial record 3 of 129 for:    Recruiting, Not yet recruiting, Available Studies | "Eating Disorders"

CBT-Eb Plus EMDR Versus CBT-Eb in Patients With Eating Disorders (TREAT-EMDR)

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ClinicalTrials.gov Identifier: NCT03156959
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Ruggeri, Mirella, Universita di Verona

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.

Condition or disease Intervention/treatment Phase
Eating Disorder Behavioral: EMDR Behavioral: CBT-Eb Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Plus Broad Form of Enhanced Cognitive Behavioural Therapy (CBT-Eb) in Patients With Eating Disorders. A Randomized Controlled Trial
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: EMDR plus CBT-Eb

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
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.

Behavioral: CBT-Eb
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.

Active Comparator: CBT-Eb alone

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
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.




Primary Outcome Measures :
  1. Changes in Severity of the Eating Disorder [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Global score of the Eating Disorder Examination (EDE)

  2. Changes in Severity of the Eating Disorder [ Time Frame: 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) ]
    Global score of the Eating Disorder Examination (EDE)


Secondary Outcome Measures :
  1. Changes in Psychopathological conditions [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Hopkins Symptom Checklist (SCL-90)

  2. Changes in Psychopathological conditions [ Time Frame: 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) ]
    Hopkins Symptom Checklist (SCL-90)

  3. Changes in the Number of patients "in remission" for general psychopathology [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Global SCL-90 score less than 1

  4. Changes in the Number of patients "in remission" for general psychopathology [ Time Frame: 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) ]
    Global SCL-90 score less than 1

  5. Changes in Eating disorder risk factors [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Eating Disorders Inventory (EDI.3)

  6. Changes in Eating disorder risk factors [ Time Frame: 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) ]
    Eating Disorders Inventory (EDI.3)

  7. Changes in Subjective impact of traumatic events [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Impact of Event Scale-Revised (IES-R)

  8. Changes in Subjective impact of traumatic events [ Time Frame: 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) ]
    Impact of Event Scale-Revised (IES-R)

  9. Changes in Intensity of dissociative experiences [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Dissociative Experience Scale (DIS-Q)

  10. Changes in Intensity of dissociative experiences [ Time Frame: 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) ]
    Dissociative Experience Scale (DIS-Q)

  11. Changes in Caregiver expressed emotions (from the patient point of view) [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Level of Expressed Emotions (LEE)

  12. Changes in Caregiver expressed emotions (from the patient point of view) [ Time Frame: 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) ]
    Level of Expressed Emotions (LEE)

  13. Changes in Global functioning [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Global Assessment of Functioning (GAF)

  14. Changes in Global functioning [ Time Frame: 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) ]
    Global Assessment of Functioning (GAF)

  15. Changes in Level of impulsiveness [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Barratt Impulsiveness Scale (BIS-11)

  16. Changes in Level of impulsiveness [ Time Frame: 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) ]
    Barratt Impulsiveness Scale (BIS-11)

  17. Changes in Alexithymia [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Toronto Alexithymia Scale (TAS-20)

  18. Changes in Alexithymia [ Time Frame: 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) ]
    Toronto Alexithymia Scale (TAS-20)

  19. Changes in Assertiveness [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Rathus Assertiveness Scale (RAS)

  20. Changes in Assertiveness [ Time Frame: 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) ]
    Rathus Assertiveness Scale (RAS)

  21. Changes in Brooding [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Penn State Worry Questionnaire (PSWQ)

  22. Changes in Brooding [ Time Frame: 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) ]
    Penn State Worry Questionnaire (PSWQ)

  23. Changes in Psychosocial damage [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Clinical Impairment Assessment Questionnaire (CIA)

  24. Changes in Psychosocial damage [ Time Frame: 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) ]
    Clinical Impairment Assessment Questionnaire (CIA)

  25. Changes in Hypomanic or manic symptoms [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Hypomania/Mania Symptom Checklist (HCL-32)

  26. Changes in Hypomanic or manic symptoms [ Time Frame: 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) ]
    Hypomania/Mania Symptom Checklist (HCL-32)

  27. Changes in Maladaptive schemes [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
    Young Schema Questionnaire (YSQ)

  28. Changes in Maladaptive schemes [ Time Frame: 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) ]
    Young Schema Questionnaire (YSQ)



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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156959


Contacts
Contact: Mirella Ruggeri, Prof +39 045 8127482 mirella.ruggeri@univr.it
Contact: Rosa Bruna Dall'Agnola, Dr +39 045 8124952 rosa.dallagnola@univr.it

Locations
Italy
Regional Reference Centre For Eating Disorders of Verona Recruiting
Verona, Italy, 37134
Contact: Mirella Ruggeri, Prof    +39 045 8127482    mirella.ruggeri@univr.it   
Contact: Rosa Bruna Dall'Agnola, Dr    +39 045 8124952    rosa.dallagnola@univr.it   
Sponsors and Collaborators
Ruggeri, Mirella
Investigators
Study Chair: Mirella Ruggeri, Prof University of Verona, Section of Psychiatry

Publications:

Responsible Party: Ruggeri, Mirella, Full Professor in Psychiatry, Universita di Verona
ClinicalTrials.gov Identifier: NCT03156959     History of Changes
Other Study ID Numbers: 1153CESC
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ruggeri, Mirella, Universita di Verona:
Eating disorders
Cognitive Behavioral Therapy
Eye Movement Desensitization and Processing

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders