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Feeding and Eating DisordersTCRTRCTNCT03808467

Cognitive Training for Patients With Eating Disorders

A study testing Cognitive Remediation Therapy and Treatment as usual in people with Feeding and Eating Disorders and Anorexia Nervosa, run by Norwegian University of Science and Technology at 3 sites in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 36 years, women only
What is being tested?
Cognitive Remediation Therapy and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesNorway
Study dates
1 Mar 2019to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 16 to 36 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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:
  • the Inhibit, Shift, Plan/ Organize and/ or Global Executive Composite indexes of the self-report measure the BRIEF-A (reversed)
  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Norway3 sites
  • Levanger Hospital, Nord-Trøndelag Hospital Trust

    Levanger, N-T

  • Department of Psychology, Norwegian University of Science and Technology

    Trondheim, N-7491

  • St Olavs Hospital HF

    Trondheim

Other trials in Norway

About this study

Official title: Transdiagnostic Cognitive Remediation Therapy for Patients With Eating Disorders: a Randomized Controlled Trial

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.

Being tested
Cognitive Remediation Therapy, Treatment as usual
Keywords
Cognitive Remediation, Neuropsychology, Neuropsychological Tests
Medical subject headings
Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Remediation TherapyBehavioural

    Also called CRT

    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).

  • Treatment as usualOther

    Also called TAU

    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.

Study groups in NCT03808467
Study groupRoleWhat they receive
CRT + TAUExperimentalCognitive Remediation Therapy + Treatment As Usual
Receives: Behavioral: Cognitive Remediation Therapy; Other: Treatment as usual
TAU onlyOtherTreatment As Usual
Receives: Other: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BRIEF-A

    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.

    Measured: 6 month follow-up

  2. EDI-3

    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.

    Measured: 6 month follow-up

  3. EDE-Q

    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.

    Measured: 6 month follow-up

  4. EDFLIX

    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.

    Measured: 6 month follow-up

  5. WCST

    Mental flexibility as measured by the Wisconsin Card Sorting Test (WCST)

    Measured: 6 month follow-up

  6. RCFT

    Central coherence as measured by the Rey Complex Figure Test (RCFT)

    Measured: 6 month follow-up

  7. CWIT

    Inhibition as measured by the Color-Word Interference Test (CWIT)

    Measured: 6 month follow-up

Secondary outcomes (16)
  1. SF-36v2

    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.

    Measured: 6 month follow-up

  2. TMT

    Performance on the Trail Making Test (TMT)

    Measured: Post-intervention (12 weeks after baseline assessment), 6 month follow-up

  3. IGT

    Performance on the Iowa Gambling Task (IGT)

    Measured: Post-intervention (12 weeks after baseline assessment), 6 month follow-up

  4. Tower Test

    Performance on the Tower Test

    Measured: Post-intervention (12 weeks after baseline assessment), 6 month follow-up

  5. CCPT-3

    Performance on Conner's Continuous Performance Test- 3rd Edition (CCPT-3)

    Measured: Post-intervention (12 weeks after baseline assessment), 6 month follow-up

  6. BDI-II

    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

    Measured: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up

  7. BAI

    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.

    Measured: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up12 weeks (post-treatment)

  8. MCQ-30

    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.

    Measured: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up

  9. Actigraphy

    Actigraphy outcome measures from software

    Measured: 6 months

  10. BRIEF-A

    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.

    Measured: Post-intervention (12 weeks after baseline assessment), 2 year follow-up

  11. EDI-3

    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.

    Measured: Post-intervention (12 weeks after baseline assessment), 2 year follow-up

  12. EDE-Q

    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.

    Measured: Post-intervention (12 weeks after baseline assessment), 2 year follow-up

  13. EDFLIX

    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.

    Measured: Post-intervention (12 weeks after baseline assessment), 2 year follow-up

  14. WCST

    Mental flexibility as measured by the Wisconsin Card Sorting Test (WCST)

    Measured: Post-intervention (12 weeks after baseline assessment), 2 year follow-up

  15. RCFT

    Central coherence as measured by the Rey Complex Figure Test (RCFT)

    Measured: Post-intervention (12 weeks after baseline assessment), 2 year follow-up

  16. CWIT

    Inhibition as measured by the Color-Word Interference Test (CWIT)

    Measured: Post-intervention (12 weeks after baseline assessment), 2 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2019
  2. Study start1 Mar 2019
  3. Primary completion22 Jun 2024
  4. Study completionJul 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03808467
Sponsor's protocol ID
2018/1182
Acronym
TCRTRCT
Status last verified
Dec 2025
First submitted
18 Dec 2018
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Thorsrud T, Thorsen L, Hjemdal O, Dahlgren CL, Micali N, Weider S. Neuropsychological Profiles in Patients With Restrictive or Binge/Purge Subtype Eating Disorders: A Continuum Approach. Eur Eat Disord Rev. 2026 Jan;34(1):178-190. doi: 10.1002/erv.70019. Epub 2025 Jul 29.

    PubMed 40734305
  • Thorsrud T, Bang MA, Dahlgren CL, Nordfjaern T, Weider S. Cognitive remediation therapy for patients with eating disorders: a qualitative study. J Eat Disord. 2024 Sep 13;12(1):142. doi: 10.1186/s40337-024-01101-0.

    PubMed 39272210

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Remediation Therapy and Treatment as usual in people with Feeding and Eating Disorders and Anorexia Nervosa, run by Norwegian University of Science and Technology at 3 sites in Norway.

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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. 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?

This study is still under way. Results are not available in the source record yet.

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?

BRIEF-A (time frame: 6 month follow-up). The study lists 7 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 NCT03808467, which also lists 2 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 12 Dec 2025.

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