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Cognitive Training for Patients With Eating Disorders (TCRTRCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03808467
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
St. Olavs Hospital
Levanger Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
Eating disorders are severe mental illnesses, mainly affecting adolescent- and young adult women. The prognoses for eating disorders are relatively poor, and a large part of patients with these illnesses do not benefit from available conventional therapies. After decades of research into the causes of eating disorders, there is now compelling evidence for specific neuropsychological difficulties in patients affected by eating disorders. These neuropsychological difficulties are characterized by cognitive and behavioral rigidity (poor set-shifting abilities), as well as difficulties related to central coherence, planning and impulse control. Surprisingly, few therapies specifically target these difficulties, and they are rarely incorporated into treatment. Cognitive Remediation Therapy has shown promising results as an adjunctive therapeutic intervention for patients with anorexia Nervosa. The primary aim of this randomized controlled trial is thus to investigate the effect of Cognitive Remediation Therapy on neuropsychological function, symptoms of eating disorders and general mental health, quality of life and motor activity in women with both eating disorders (transdiagnostic) and these specific cognitive difficulties.

Condition or disease Intervention/treatment Phase
Feeding and Eating Disorders Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder Behavioral: Cognitive Remediation Therapy Other: Treatment as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transdiagnostic Cognitive Remediation Therapy for Patients With Eating Disorders: a Randomized Controlled Trial
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: CRT + TAU
Cognitive Remediation Therapy + Treatment As Usual
Behavioral: Cognitive Remediation Therapy
Nine individual transdiagnostic CRT sessions will be delivered once per week, each session lasting approximately 45 minutes. Building on previously published CRT manuals for anorexia nervosa and obesity, a transdiagnostic CRT manual developed for this project will be used during the course of CRT treatment. The manual comprises an introduction to CRT for eating disorders, and a detailed nine-session structure incorporating cognitive and behavioral tasks in the following domains; (1) planning-impulsivity, (2) flexibility-rigidity and (3) central coherence-attention to details. A certain set of guiding questions will accompany each task with the aim of stimulating metacognition (i.e. thinking about thinking).
Other Name: CRT

Other: Treatment as usual
According to Norwegian guidelines established by the Norwegian Directorate of Health, the patients are likely to receive treatment focusing directly on the ED symptomatology, i.e normalization of weight in the case of underweight, reduction of binging and purging and normalization of other ED related thoughts and behaviors. Since both in-patients, patients in day treatment and out-patients will be included in the study, the number of hours with therapeutic interventions will vary. Records of the participants` received number of therapeutic hours will be logged weekly during the intervention for participants in both arms of the study.
Other Name: TAU

TAU only
Treatment As Usual
Other: Treatment as usual
According to Norwegian guidelines established by the Norwegian Directorate of Health, the patients are likely to receive treatment focusing directly on the ED symptomatology, i.e normalization of weight in the case of underweight, reduction of binging and purging and normalization of other ED related thoughts and behaviors. Since both in-patients, patients in day treatment and out-patients will be included in the study, the number of hours with therapeutic interventions will vary. Records of the participants` received number of therapeutic hours will be logged weekly during the intervention for participants in both arms of the study.
Other Name: TAU




Primary Outcome Measures :
  1. BRIEF-A [ Time Frame: 6 month follow-up ]
    Executive function according to the self-report questionnaire the Behaviour Rating Inventory of Executive Function, Adult (BRIEF-A). This questionnaire consist of 75 items on which the patient`s symptoms are rated on a 3-point Likert scale. The questionnaire provides a Global Executive Composite score (range 75-225) and two index scores: the Behavioral Regulation Index (range 30-90) and the Metacognitive Index (range 40-120) in addition to nine subscales: Inhibit (range 8-24), Shift (range 6-18), Emotional control (range 10-30), Self-monitor (range 6-18), Initiate (range 8-24), Working memory (range 8-24), Plan/organize (range 10-30), Task monitor (range 6-18) and Organization of materials (range 8-24). Higher scores indicate more executive difficulties.

  2. EDI-3 [ Time Frame: 6 month follow-up ]
    Eating disorder- and general psychological symptoms according to the Eating Disorder Inventory, 3rd version (EDI-3). EDI-3 consist of 91 items rated on a 6 point Likert scale. The items are organized in to 12 primary scales: Drive For Thinness (range 0-28), Bulimia (range 0 -32), Body Dissatisfaction (range 0-40), Low Self-Esteem (range 0-24), Personal Alienation (range 0-28), Interpersonal Insecurity (range 0-28), Interpersonal Alienation (range 0-28), Interoceptive Deficits (range 0-36), Impulse Disregulation (range 0- 32), Perfectionism (range 0-24), Asceticism (range 0-28) and Maturity Fears (range 0-32). In addition, the EDI-3 also provides 6 composites: Eating Concerns Composite (range 0-100), Ineffectiveness (range 0-48), Interpersonal Problems (range 0- 52), Affective Problems (range 0-62), Overcontrol (range 0-52) and Global Psychological Maladjustment (range 0-252). Higher scores indicates more severe problems.

  3. EDE-Q [ Time Frame: 6 month follow-up ]
    Eating disorder behaviors (binge eating and inappropriate weight compensatory behaviors) and attitudinal features of eating disorders over the previous 28 days is measured by the Eating Disorder Examination (EDE-Q), v. 16.0. The EDE-Q includes 22-attitudinal items that are each rated using seven-point forced-choice format. The items are grouped into four clinically-derived subscales each consisting of five to eight items: Dietary restraint, Eating concern, Weight concern, and Shape concern. The score of each subscale is calculated as the average of item scores within the subscale and yields a range of 0-6. The global score is calculated as the average of the four subscale scores (range 0-6). Higher scores indicates greater pathology.

  4. EDFLIX [ Time Frame: 6 month follow-up ]
    Mental flexibility is measured according to the self-report questionnaire the Eating Disorder Flexibility Index (EDFLIX). This questionnaire consist of 36 items scored on a 6-point Likert scale. The questionnaire provides a total score (range 36-216) and three index scores: EDFLIX-GF (General Flexibility; range 17-102), EDFLIX-FoEx (Food and Exercise Flexibility; range 13-78) and EDFLIX-WeSh (Weight and Shape Flexibility; range 6-36). Higher scores indicate more flexibility.

  5. WCST [ Time Frame: 6 month follow-up ]
    Mental flexibility as measured by the Wisconsin Card Sorting Test (WCST)

  6. RCFT [ Time Frame: 6 month follow-up ]
    Central coherence as measured by the Rey Complex Figure Test (RCFT)

  7. CWIT [ Time Frame: 6 month follow-up ]
    Inhibition as measured by the Color-Word Interference Test (CWIT)


Secondary Outcome Measures :
  1. SF-36v2 [ Time Frame: 6 month follow-up ]
    Health related quality of life (HRQOL) was measured according to the Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2). This questionnaire consist of 36 items on which the patient`s responses are rated on a 3-point (item 3), 5-point (item 1, 2, 4, 5, 6, 8, 9, 10 and 11) or 6-point scale (item 7). The items are organized into eight domains: Physical Functioning (PF; 10 items), Role- Physical (4 items), Bodily Pain (BP; 2 items), General Health (GH; 5 items), Vitality (VT; 4 items), Social Functioning (SF; 2 items), Role- Emotional (3 items), and Mental Health (5 items). Furthermore, two summary measures can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Transformed scores are calculated and yields a range of 0-100 for each domain- or summary measure. Higher scores indicate better HRQOL.

  2. TMT [ Time Frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up ]
    Performance on the Trail Making Test (TMT)

  3. IGT [ Time Frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up ]
    Performance on the Iowa Gambling Task (IGT)

  4. Tower Test [ Time Frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up ]
    Performance on the Tower Test

  5. CCPT-3 [ Time Frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up ]
    Performance on Conner`s Continuous Performance Test- 3rd Edition (CCPT-3)

  6. BDI-II [ Time Frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up ]
    Symptoms of depression according to the self-report questionnaire the Beck Depression Inventory- Second edition (BDI-II). This questionnaire consist of 21 items scored on a 4-point Likert scale (range 0- 63). Higher scores indicate more depression

  7. BAI [ Time Frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up12 weeks (post-treatment) ]
    Symptoms of anxiety according to the self-report questionnaire the Beck Anxiety Inventory (BAI). This questionnaire consist of 21 items scored on a 4-point Likert scale (range 0- 63). Higher scores indicate more anxiety.

  8. MCQ-30 [ Time Frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up ]
    Metacognitions as measured according to the Metacognitions questionnaire (MCQ-30). This questionnaire consist of 30 items scored on a 4-point Likert scale. The questionnaire provides a total score (range 30- 120) and 5 subscales: Positive beliefs about worry (range 6-24); Negative beliefs about worry concerning uncontrollability and danger (range 6-24), Cognitive confidence (range 6-24); Need to control thoughts (range 6-24) and Cognitive self-consciousness (range 6-24). Higher scores indicate more dysfunctional metacognitions.

  9. Actigraphy [ Time Frame: 6 months ]
    Actigraphy outcome measures from software

  10. BRIEF-A [ Time Frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up ]
    Executive function according to the self-report questionnaire the Behaviour Rating Inventory of Executive Function, Adult (BRIEF-A). This questionnaire consist of 75 items on which the patient`s symptoms are rated on a 3-point Likert scale. The questionnaire provides a Global Executive Composite score (range 75-225) and two index scores: the Behavioral Regulation Index (range 30-90) and the Metacognitive Index (range 40-120) in addition to nine subscales: Inhibit (range 8-24), Shift (range 6-18), Emotional control (range 10-30), Self-monitor (range 6-18), Initiate (range 8-24), Working memory (range 8-24), Plan/organize (range 10-30), Task monitor (range 6-18) and Organization of materials (range 8-24). Higher scores indicate more executive difficulties.

  11. EDI-3 [ Time Frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up ]
    Eating disorder- and general psychological symptoms according to the Eating Disorder Inventory, 3rd version (EDI-3). EDI-3 consist of 91 items rated on a 6 point Likert scale. The items are organized in to 12 primary scales: Drive For Thinness (range 0-28), Bulimia (range 0 -32), Body Dissatisfaction (range 0-40), Low Self-Esteem (range 0-24), Personal Alienation (range 0-28), Interpersonal Insecurity (range 0-28), Interpersonal Alienation (range 0-28), Interoceptive Deficits (range 0-36), Impulse Disregulation (range 0- 32), Perfectionism (range 0-24), Asceticism (range 0-28) and Maturity Fears (range 0-32). In addition, the EDI-3 also provides 6 composites: Eating Concerns Composite (range 0-100), Ineffectiveness (range 0-48), Interpersonal Problems (range 0- 52), Affective Problems (range 0-62), Overcontrol (range 0-52) and Global Psychological Maladjustment (range 0-252). Higher scores indicates more severe problems.

  12. EDE-Q [ Time Frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up ]
    Eating disorder behaviors (binge eating and inappropriate weight compensatory behaviors) and attitudinal features of eating disorders over the previous 28 days is measured by the Eating Disorder Examination (EDE-Q), v. 16.0. The EDE-Q includes 22-attitudinal items that are each rated using seven-point forced-choice format. The items are grouped into four clinically-derived subscales each consisting of five to eight items: Dietary restraint, Eating concern, Weight concern, and Shape concern. The score of each subscale is calculated as the average of item scores within the subscale and yields a range of 0-6. The global score is calculated as the average of the four subscale scores (range 0-6). Higher scores indicates greater pathology.

  13. EDFLIX [ Time Frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up ]
    Mental flexibility is measured according to the self-report questionnaire the Eating Disorder Flexibility Index (EDFLIX). This questionnaire consist of 36 items scored on a 6-point Likert scale. The questionnaire provides a total score (range 36-216) and three index scores: EDFLIX-GF (General Flexibility; range 17-102), EDFLIX-FoEx (Food and Exercise Flexibility; range 13-78) and EDFLIX-WeSh (Weight and Shape Flexibility; range 6-36). Higher scores indicate more flexibility.

  14. WCST [ Time Frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up ]
    Mental flexibility as measured by the Wisconsin Card Sorting Test (WCST)

  15. RCFT [ Time Frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up ]
    Central coherence as measured by the Rey Complex Figure Test (RCFT)

  16. CWIT [ Time Frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up ]
    Inhibition as measured by the Color-Word Interference Test (CWIT)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 36 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being in in-patient-, day- or out-patient treatment for an eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder or OSFED)
  • Displaying cognitive difficulties (score ≤ -1 standard deviation) on:

    1. the Inhibit, Shift, Plan/ Organize and/ or Global Executive Composite indexes of the self-report measure the BRIEF-A (reversed)
    2. the Total errors, Perseverative Responses, Perseverative Errors and/ or Learning to learn from the Wisconsin Card Sorting Test (WCST) and/ or on the Rey Complex Figure Test (RCFT) Copy condition or Q-score and/ or on condition 3 and 4 on the Color-word Interference Test from (D-KEFS)
  • Being able to understand and speak Norwegian
  • Be willing to provide written informed consent
  • Accepting random allocation to the two arms of the study

Exclusion Criteria:

  • A history of congenital or acquired brain injury (except concussions)
  • Active substance abuse
  • Psychosis
  • Intelligence quotient (IQ) less than 70

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): NCT03808467


Contacts
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Contact: Siri Weider, PhD +47 952 61 916 siri.weider@ntnu.no
Contact: Tora Thorsrud, Cand Psychol tora.thorsrud@ntnu.no

Locations
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Norway
Levanger Hospital, Nord-Trøndelag Hospital Trust Recruiting
Levanger, N-T, Norway
Contact: Hilde Ranheim         
Department of Psychology, Norwegian University of Science and Technology Recruiting
Trondheim, Norway, N-7491
St Olavs Hospital HF Recruiting
Trondheim, Norway
Contact: Olav Burkeland         
Contact: Hege K Sætherhaug         
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Levanger Hospital
Investigators
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Study Director: Ute Gabriel, PhD Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03808467     History of Changes
Other Study ID Numbers: 2018/1182
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Cognitive Remediation
Neuropsychology
Neuropsychological Tests
Additional relevant MeSH terms:
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Disease
Anorexia
Bulimia
Feeding and Eating Disorders
Anorexia Nervosa
Binge-Eating Disorder
Bulimia Nervosa
Mental Disorders
Hyperphagia
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms