<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03808467</url>
  </required_header>
  <id_info>
    <org_study_id>2018/1182</org_study_id>
    <nct_id>NCT03808467</nct_id>
  </id_info>
  <brief_title>Cognitive Training for Patients With Eating Disorders</brief_title>
  <acronym>TCRTRCT</acronym>
  <official_title>Transdiagnostic Cognitive Remediation Therapy for Patients With Eating Disorders: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Nord-Trøndelag HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Eating disorders are severe mental illnesses, mainly affecting adolescent- and young adult&#xD;
      women. The prognoses for eating disorders are relatively poor, and a large part of patients&#xD;
      with these illnesses do not benefit from available conventional therapies. After decades of&#xD;
      research into the causes of eating disorders, there is now compelling evidence for specific&#xD;
      neuropsychological difficulties in patients affected by eating disorders. These&#xD;
      neuropsychological difficulties are characterized by cognitive and behavioral rigidity (poor&#xD;
      set-shifting abilities), as well as difficulties related to central coherence, planning and&#xD;
      impulse control. Surprisingly, few therapies specifically target these difficulties, and they&#xD;
      are rarely incorporated into treatment. Cognitive Remediation Therapy has shown promising&#xD;
      results as an adjunctive therapeutic intervention for patients with anorexia Nervosa. The&#xD;
      primary aim of this randomized controlled trial is thus to investigate the effect of&#xD;
      Cognitive Remediation Therapy on neuropsychological function, symptoms of eating disorders&#xD;
      and general mental health, quality of life and motor activity in women with both eating&#xD;
      disorders (transdiagnostic) and these specific cognitive difficulties.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BRIEF-A</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EDI-3</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EDE-Q</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EDFLIX</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WCST</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Mental flexibility as measured by the Wisconsin Card Sorting Test (WCST)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RCFT</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Central coherence as measured by the Rey Complex Figure Test (RCFT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CWIT</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Inhibition as measured by the Color-Word Interference Test (CWIT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-36v2</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TMT</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 6 month follow-up</time_frame>
    <description>Performance on the Trail Making Test (TMT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGT</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 6 month follow-up</time_frame>
    <description>Performance on the Iowa Gambling Task (IGT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tower Test</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 6 month follow-up</time_frame>
    <description>Performance on the Tower Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CCPT-3</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 6 month follow-up</time_frame>
    <description>Performance on Conner's Continuous Performance Test- 3rd Edition (CCPT-3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDI-II</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BAI</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up12 weeks (post-treatment)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MCQ-30</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actigraphy</measure>
    <time_frame>6 months</time_frame>
    <description>Actigraphy outcome measures from software</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BRIEF-A</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 2 year follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EDI-3</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 2 year follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EDE-Q</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 2 year follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EDFLIX</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 2 year follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WCST</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 2 year follow-up</time_frame>
    <description>Mental flexibility as measured by the Wisconsin Card Sorting Test (WCST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RCFT</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 2 year follow-up</time_frame>
    <description>Central coherence as measured by the Rey Complex Figure Test (RCFT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CWIT</measure>
    <time_frame>Post-intervention (12 weeks after baseline assessment), 2 year follow-up</time_frame>
    <description>Inhibition as measured by the Color-Word Interference Test (CWIT)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Feeding and Eating Disorders</condition>
  <condition>Anorexia Nervosa</condition>
  <condition>Bulimia Nervosa</condition>
  <condition>Binge-Eating Disorder</condition>
  <arm_group>
    <arm_group_label>CRT + TAU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Remediation Therapy + Treatment As Usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU only</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment As Usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Remediation Therapy</intervention_name>
    <description>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).</description>
    <arm_group_label>CRT + TAU</arm_group_label>
    <other_name>CRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>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.</description>
    <arm_group_label>CRT + TAU</arm_group_label>
    <arm_group_label>TAU only</arm_group_label>
    <other_name>TAU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being in in-patient-, day- or out-patient treatment for an eating disorder (anorexia&#xD;
             nervosa, bulimia nervosa, binge eating disorder or OSFED)&#xD;
&#xD;
          -  Displaying cognitive difficulties (score ≤ -1 standard deviation) on:&#xD;
&#xD;
               1. the Inhibit, Shift, Plan/ Organize and/ or Global Executive Composite indexes of&#xD;
                  the self-report measure the BRIEF-A (reversed)&#xD;
&#xD;
               2. the Total errors, Perseverative Responses, Perseverative Errors and/ or Learning&#xD;
                  to learn from the Wisconsin Card Sorting Test (WCST) and/ or on the Rey Complex&#xD;
                  Figure Test (RCFT) Copy condition or Q-score and/ or on condition 3 and 4 on the&#xD;
                  Color-word Interference Test from (D-KEFS)&#xD;
&#xD;
          -  Being able to understand and speak Norwegian&#xD;
&#xD;
          -  Be willing to provide written informed consent&#xD;
&#xD;
          -  Accepting random allocation to the two arms of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of congenital or acquired brain injury (except concussions)&#xD;
&#xD;
          -  Active substance abuse&#xD;
&#xD;
          -  Psychosis&#xD;
&#xD;
          -  Intelligence quotient (IQ) less than 70&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>36 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ute Gabriel, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Siri Weider, PhD</last_name>
    <phone>+47 952 61 916</phone>
    <email>siri.weider@ntnu.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tora Thorsrud, Cand Psychol</last_name>
    <email>tora.thorsrud@ntnu.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Levanger Hospital, Nord-Trøndelag Hospital Trust</name>
      <address>
        <city>Levanger</city>
        <state>N-T</state>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hilde Ranheim</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Psychology, Norwegian University of Science and Technology</name>
      <address>
        <city>Trondheim</city>
        <zip>N-7491</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St Olavs Hospital HF</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olav Burkeland</last_name>
    </contact>
    <contact_backup>
      <last_name>Hege K Sætherhaug</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive Remediation</keyword>
  <keyword>Neuropsychology</keyword>
  <keyword>Neuropsychological Tests</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
    <mesh_term>Anorexia Nervosa</mesh_term>
    <mesh_term>Binge-Eating Disorder</mesh_term>
    <mesh_term>Bulimia Nervosa</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03808467
org study id: 2018/1182
nct id: NCT03808467
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: BRIEF-A
time frame: 6 month follow-up
description: 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.
measure: EDI-3
time frame: 6 month follow-up
description: 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.
measure: EDE-Q
time frame: 6 month follow-up
description: 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.
measure: EDFLIX
time frame: 6 month follow-up
description: 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.
measure: WCST
time frame: 6 month follow-up
description: Mental flexibility as measured by the Wisconsin Card Sorting Test (WCST)
measure: RCFT
time frame: 6 month follow-up
description: Central coherence as measured by the Rey Complex Figure Test (RCFT)
measure: CWIT
time frame: 6 month follow-up
description: Inhibition as measured by the Color-Word Interference Test (CWIT)
measure: SF-36v2
time frame: 6 month follow-up
description: 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.
measure: TMT
time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
description: Performance on the Trail Making Test (TMT)
measure: IGT
time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
description: Performance on the Iowa Gambling Task (IGT)
measure: Tower Test
time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
description: Performance on the Tower Test
measure: CCPT-3
time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
description: Performance on Conner's Continuous Performance Test- 3rd Edition (CCPT-3)
measure: BDI-II
time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up
description: 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
measure: BAI
time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up12 weeks (post-treatment)
description: 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.
measure: MCQ-30
time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up
description: 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.
measure: Actigraphy
time frame: 6 months
description: Actigraphy outcome measures from software
measure: BRIEF-A
time frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
description: 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.
measure: EDI-3
time frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
description: 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.
measure: EDE-Q
time frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
description: 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.
measure: EDFLIX
time frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
description: 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.
measure: WCST
time frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
description: Mental flexibility as measured by the Wisconsin Card Sorting Test (WCST)
measure: RCFT
time frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
description: Central coherence as measured by the Rey Complex Figure Test (RCFT)
measure: CWIT
time frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
description: Inhibition as measured by the Color-Word Interference Test (CWIT)
arm group label: CRT + TAU
arm group type: Experimental
description: Cognitive Remediation Therapy + Treatment As Usual
arm group label: TAU only
arm group type: Other
description: Treatment As Usual
intervention type: Behavioral
intervention name: Cognitive Remediation Therapy
description: 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).
arm group label: CRT + TAU
other name: CRT
intervention type: Other
intervention name: Treatment as usual
description: 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.
arm group label: CRT + TAU
arm group label: TAU only
other name: TAU
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 36 Years
healthy volunteers: No
last name: Ute Gabriel, PhD
role: Study Director
affiliation: Norwegian University of Science and Technology
last name: Siri Weider, PhD
phone: +47 952 61 916
email: siri.weider@ntnu.no
last name: Tora Thorsrud, Cand Psychol
email: tora.thorsrud@ntnu.no
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
country: Norway
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Bulimia
mesh term: Feeding and Eating Disorders
mesh term: Anorexia Nervosa
mesh term: Binge-Eating Disorder
mesh term: Bulimia Nervosa
sharing ipd: Undecided