Clinical trial NCT03808467: Cognitive Training for Patients With Eating Disorders
Official title: Transdiagnostic Cognitive Remediation Therapy for Patients With Eating Disorders: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Feeding and Eating Disorders
Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Keywords: Cognitive Remediation
Neuropsychology
Neuropsychological Tests
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Helse Nord-Trøndelag HF
First posted: 2019-01-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: BRIEF-A
timeFrame: 6 month follow-up
measure: EDI-3
timeFrame: 6 month follow-up
measure: EDE-Q
timeFrame: 6 month follow-up
measure: EDFLIX
timeFrame: 6 month follow-up
measure: WCST
timeFrame: 6 month follow-up
measure: RCFT
timeFrame: 6 month follow-up
measure: CWIT
timeFrame: 6 month follow-up
Secondary outcomes:
measure: SF-36v2
timeFrame: 6 month follow-up
measure: TMT
timeFrame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
measure: IGT
timeFrame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
measure: Tower Test
timeFrame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
measure: CCPT-3
timeFrame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
measure: BDI-II
timeFrame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up
measure: BAI
timeFrame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up12 weeks (post-treatment)
measure: MCQ-30
timeFrame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up
measure: Actigraphy
timeFrame: 6 months
measure: BRIEF-A
timeFrame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
measure: EDI-3
timeFrame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
measure: EDE-Q
timeFrame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
measure: EDFLIX
timeFrame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
measure: WCST
timeFrame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
measure: RCFT
timeFrame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
measure: CWIT
timeFrame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Levanger Hospital, Nord-Trøndelag Hospital Trust
state: N-T
city: Trondheim
country: Norway
facility: Department of Psychology, Norwegian University of Science and Technology
city: Trondheim
country: Norway
facility: St Olavs Hospital HF
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ute Gabriel, PhD
role: STUDY_DIRECTOR
References: