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Clinical Trials/NCT02484599
NCT02484599UnknownPhase 1

Evaluation of a Computerized Attention Training (CAT) to Modify Attention Bias for Food Cues in Anorexia Nervosa Patients

King's College London1 site in 1 country50 target enrollmentStarted: June 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Enrollment
50
Locations
1
Primary Endpoint
Attention bias

Study Overview

Brief Summary

The purpose of this study is to test the therapeutic effects of a computerized attention training for patients with Anorexia Nervosa (AN). The primary aim is to determine if a computerized attention training can modify attention towards food and ameliorate eating disorder symptoms and related difficulties, such as anxiety. The secondary aim is to explore underlying mechanisms that contribute to these improvements. The stability of potentially observed effects over a one-month period will also be determined.

Detailed Description

Recently, attention bias modification (ABM) has successfully been applied in the field of anxiety disorders and emerging evidence suggests that attention bias modification can ameliorate attention bias for threatening stimuli. ABM is based on the premise that if biased attention maintains disorder symptoms, a modification of the bias should reduce symptoms. The advantage of ABM is that it operates implicitly, thereby offering a more indirect, less deliberate procedure. This requires less cognitive control compared to the effortful and explicit psychotherapeutic treatment of cognitive biases. As food-related fears and avoidance in AN patients have been recognized as important anxiety-related symptoms, ABM seems particularly suitable to treat food-related fears and avoidance, especially because AN patients might be unaware of their avoidance strategy. The aim of this study is to test if food-related fears and food avoidance can be changed by experimentally modifying attention towards food in Anorexia Nervosa patients using an innovative computerized training paradigm (computerized attention training - CAT) and to evaluate related change in symptoms.

The investigators hypothesize that the active CAT will change attentional processing of food cues (research aim 1), transfer to changes in food-related fears and food avoidance, and to improvements in AN symptoms and weight in the short term (research aim 2) and longer term (research aim 3).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • BMI < 18.5 5 kg/m2
  • Current diagnosis of AN-restricting type, AN-Binge/purging type or Eating Disorder Not Otherwise Specified (EDNOS) - Anorexia type
  • Fluent in English

Exclusion Criteria

  • Currently taking a dose of any psychoactive medication that has not been stable for at least 14 days prior to participation in the study
  • Currently meeting the diagnostic criteria of another major psychiatric disorder (e.g., major depressive disorder, substance dependence, schizophrenia or bipolar disorder) needing treatment in its own right
  • Learning and developmental impairments
  • If the disorder is currently life threatening
  • If patients are currently suicidal
  • If patients are currently having extreme physiological complications or co-morbid alcohol and drug-abuse disorders

Arms & Interventions

CAT active attention bias modification

Experimental

Active computerized attention training (CAT). Attention training via repeated trials of a modified anti-saccade task with concurrent assessment of eye-movements intended to direct attention towards food stimuli using pictorial food and non-food stimuli (see Werthmann, Field, Roefs, Nederkoorn, & Jansen, 2014).

Intervention: Computerized attention training (CAT) (Behavioral)

CAT sham bias modification

Placebo Comparator

Sham computerized attention training. Attention training via repeated trials of a modified anti-saccade task with concurrent assessment of eye-movements not intended to change attention processing of food stimuli using pictures of two different non-food stimuli categories (e.g. household and musical instruments).

Intervention: Sham computerized attention training (control condition) (Behavioral)

Outcomes

Primary Outcomes

Attention bias

Time Frame: max. 2 weeks (pre and post attention bias modification training)

The dot-probe task with concurrent assessment of eye-movements will be used for the assessment of attention bias at baseline and post-treatment.

Secondary Outcomes

  • Body Mass Index(max. 2 (pre and post attention bias modification training) and after 4 weeks (follow-up).)
  • Eating Disorder symptoms(max. 2 week (pre and post attention bias modification training) and at 4 weeks follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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