Cognitive Training for Patients With Eating Disorders

NCT03808467 | Active Not Recruiting

• 1 other identifier: 2018/1182
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Feeding and Eating Disorders

Keywords

Cognitive Remediation; Neuropsychology; Neuropsychological Tests

Outcome Measures

Primary Outcomes (7)

• 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.

  6 month follow-up

• 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.

  6 month follow-up

• 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.

  6 month follow-up

• 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.

  6 month follow-up

• WCST

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

  6 month follow-up

• RCFT

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

  6 month follow-up

• CWIT

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

  6 month follow-up

Secondary Outcomes (16)

• SF-36v2

  6 month follow-up

• TMT

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

• IGT

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

• Tower Test

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

• CCPT-3

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

Study Arms (2)

CRT + TAU

EXPERIMENTAL

Cognitive Remediation Therapy + Treatment As Usual

Behavioral: Cognitive Remediation Therapy; Other: Treatment as usual

TAU only

OTHER

Treatment As Usual

Other: Treatment as usual

Interventions

Treatment as usual OTHER

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.

Also known as: TAU

CRT + TAU; TAU only

Cognitive Remediation Therapy BEHAVIORAL

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).

Also known as: CRT

CRT + TAU

Eligibility Criteria

• Age: 16 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Olavs Hospital: collaborator
• Helse Nord-Trøndelag HF: collaborator
• Norwegian University of Science and Technology: lead

Study Sites (3)

Levanger Hospital, Nord-Trøndelag Hospital Trust

Levanger, N-T, Norway

Location

Department of Psychology, Norwegian University of Science and Technology

Trondheim, N-7491, Norway

Location

St Olavs Hospital HF

Trondheim, Norway

Location

Related Publications (2)

• 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.

  PMID: 40734305 DERIVED

• 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.

  PMID: 39272210 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Ute Gabriel, PhD

  Norwegian University of Science and Technology

  STUDY DIRECTOR

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

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 17, 2019
• Study Start: March 1, 2019
• Primary Completion: June 22, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

NO (3)