Social Information Processing in Adolescents With Eating Disorders

NCT03563755 | Unknown

• 1 other identifier: 229005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This research project aims to examine whether adding an online programme of cognitive training exercises may be a helpful addition to treatment as usual for young people with eating disorders. The cognitive training exercises aim to modify distortions in attention and thinking during hypothetical, ambiguous social interactions involving the risk of social rejection. All participants will complete a baseline assessment consisting of a battery of questionnaires and computerised tasks, to assess attention and thinking during ambiguous social interactions involving the risk of social rejection. Participants who display distortions in attention and thinking will then be randomised to one of two groups. In one group participants will receive the computerised training alongside their usual treatment. In the other group participants will continue to receive their treatment as usually only. Healthy controls will also be invited to take part in the baseline assessment to allow for comparisons between clinical and non-clinical groups.

Conditions

Eating Disorders in Adolescence

Outcome Measures

Primary Outcomes (2)

• Change in attentional bias towards positively valenced faces

  Attentional probe assessment task and visual search task: reaction times (milliseconds) and accuracy

  End of intervention (3 weeks post-randomisation)

• Change in positive interpretations of ambiguous social scenarios

  Sentence completion task and test trials from ambiguous scenarios training (frequencies of positive, neutral and negative interpretations).

  End of intervention (3 weeks post-randomisation)

Secondary Outcomes (4)

• Change in self-reported frequency of experiencing various symptoms of anxiety

  End of intervention (3 weeks post-randomisation)

• Change in self-reported frequency of experiencing various symptoms of low mood

  End of intervention (3 weeks post-randomisation)

• Change in Eating Disorder symptoms

  End of intervention (3 weeks post-randomisation)

• Change in self-reported interpersonal sensitivity

  End of intervention (3 weeks post-randomisation)

Study Arms (2)

Cognitive Bias Modification (CBM) + Treatment as usual

EXPERIMENTAL

Participants will receive access to a 3-week online training programme alongside their usual treatment.

Other: Cognitive Bias Modification

Treatment as usual

NO INTERVENTION

Participants will continue to receive their usual treatment.

Interventions

Cognitive Bias Modification OTHER

CBM-Attention (CBM-A) will be used with the aim of ameliorating negative cognitive biases in attention by redirecting attention towards positive social stimuli (accepting faces). Similarly CBM-Interpretation (CBM-I) will be used to ameliorate negative interpretation bias, by reinforcing benign outcomes of ambiguous social scenarios. Implementation intentions will be used to guide participants in planning new ways to face difficult social situations involving the risk of social rejection/criticism. Participants will continue to receive their usual treatment.

Cognitive Bias Modification (CBM) + Treatment as usual

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Fluency in English
• Aged 13-17
• With an eating disorder diagnosis according to the DSM-5

You may not qualify if:

• Severe psychiatric comorbidity requiring treatment in its' own right (e.g. psychosis)
• Neurological condition (e.g. epilepsy)
• Severe visual impairment uncorrected with visual aids (eyewear)
• Not receiving specialist treatment for an eating disorder
• Fluency in English
• Aged 13-17
• Current psychiatric diagnosis according to the DSM-5 (e.g. depression, anxiety)
• History of a psychiatric disorder
• Neurological condition (e.g. epilepsy)
• Severe visual impairment uncorrected with visual aids (eyewear)

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator
• South West London and St George's Mental Health NHS Trust: collaborator
• Ellern Mede Ridgeway: collaborator
• Ellern Mede Barnet: collaborator

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

RECRUITING

Study Officials

• Valentina Cardi, PhD

  King's College London

  STUDY DIRECTOR

Central Study Contacts

Katie Rowlands, BSc

CONTACT

0207 848 5980; katie.rowlands@kcl.ac.uk

Valentina Cardi, PhD

CONTACT

0207 848 5972; valentina.cardi@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 20, 2018
• Study Start: March 28, 2018
• Primary Completion: March 28, 2020
• Study Completion: March 28, 2020
• Last Updated: September 4, 2019

Record last verified: 2019-08

Locations

GB (1)