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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
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).
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 month follow-up
WCST
Mental flexibility as measured by the Wisconsin Card Sorting Test (WCST)
Time frame: 6 month follow-up
RCFT
Central coherence as measured by the Rey Complex Figure Test (RCFT)
Time frame: 6 month follow-up
CWIT
Inhibition as measured by the Color-Word Interference Test (CWIT)
Time frame: 6 month follow-up
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.
Time frame: 6 month follow-up
TMT
Performance on the Trail Making Test (TMT)
Time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
IGT
Performance on the Iowa Gambling Task (IGT)
Time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
Tower Test
Performance on the Tower Test
Time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
CCPT-3
Performance on Conner's Continuous Performance Test- 3rd Edition (CCPT-3)
Time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up
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
Time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up
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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.
Time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up12 weeks (post-treatment)
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.
Time frame: Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up
Actigraphy
Actigraphy outcome measures from software
Time frame: 6 months
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.
Time frame: Post-intervention (12 weeks after baseline assessment), 2 year 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.
Time frame: Post-intervention (12 weeks after baseline assessment), 2 year 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.
Time frame: Post-intervention (12 weeks after baseline assessment), 2 year 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.
Time frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
WCST
Mental flexibility as measured by the Wisconsin Card Sorting Test (WCST)
Time frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
RCFT
Central coherence as measured by the Rey Complex Figure Test (RCFT)
Time frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up
CWIT
Inhibition as measured by the Color-Word Interference Test (CWIT)
Time frame: Post-intervention (12 weeks after baseline assessment), 2 year follow-up