Cognitive Training for Patients With Eating Disorders

NCT ID: NCT03808467

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2026-07-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CRT + TAU

Cognitive Remediation Therapy + Treatment As Usual

Group Type: EXPERIMENTAL

Cognitive Remediation Therapy

Intervention Type: 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).

Treatment as usual

Intervention Type: 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.

TAU only

Treatment As Usual

Group Type: OTHER

Treatment as usual

Intervention Type: 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.

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

CRT; TAU

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ute Gabriel, PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

Levanger Hospital, Nord-Trøndelag Hospital Trust

Levanger, N-T, Norway

Department of Psychology, Norwegian University of Science and Technology

Trondheim, , Norway

St Olavs Hospital HF

Trondheim, , Norway

Countries

Norway

References

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. 2025 Jul 29. doi: 10.1002/erv.70019. Online ahead of print.

Reference Type: DERIVED

PMID: 40734305 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39272210 (View on PubMed)

Other Identifiers

2018/1182

Identifier Type: -

Identifier Source: org_study_id