NCT02484599

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

June 25, 2015

Last Update Submit

July 7, 2015

Conditions

Keywords

Eating DisordersAnorexia NervosaAttention biasAttention bias modification

Outcome Measures

Primary Outcomes (1)

  • Attention bias

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

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

Secondary Outcomes (2)

  • Eating Disorder symptoms

    max. 2 week (pre and post attention bias modification training) and at 4 weeks follow-up

  • Body Mass Index

    max. 2 (pre and post attention bias modification training) and after 4 weeks (follow-up).

Other Outcomes (2)

  • Eating Behaviour

    max. 2 weeks

  • Approach and avoidance tendencies

    max. 2 weeks

Study Arms (2)

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).

Behavioral: Computerized attention training (CAT)

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).

Behavioral: Sham computerized attention training (control condition)

Interventions

Three sessions of active computerized attention training.

Also known as: Attention bias modification training
CAT active attention bias modification

Three sessions of sham computerized attention training.

CAT sham bias modification

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatry, Psychology and Neuroscience

London, SE5 8AF, United Kingdom

RECRUITING

Related Publications (2)

  • Neimeijer RA, de Jong PJ, Roefs A. Automatic approach/avoidance tendencies towards food and the course of anorexia nervosa. Appetite. 2015 Aug;91:28-34. doi: 10.1016/j.appet.2015.03.018. Epub 2015 Mar 24.

    PMID: 25817483BACKGROUND
  • Werthmann J, Field M, Roefs A, Nederkoorn C, Jansen A. Attention bias for chocolate increases chocolate consumption--an attention bias modification study. J Behav Ther Exp Psychiatry. 2014 Mar;45(1):136-43. doi: 10.1016/j.jbtep.2013.09.009. Epub 2013 Sep 29.

    PMID: 24140811BACKGROUND

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jessica Werthmann, PhD

    Institute of Psychiatry, Psychology and Neuroscience, King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

June 29, 2015

Study Start

June 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations