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Clinical Trials/NCT03563755
NCT03563755
Unknown
Not Applicable

Social Information Processing in Adolescents With Eating Disorders: Implications for Theory and Clinical Practice

King's College London1 site in 1 country80 target enrollmentMarch 28, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eating Disorders in Adolescence
Sponsor
King's College London
Enrollment
80
Locations
1
Primary Endpoint
Change in positive interpretations of ambiguous social scenarios
Last Updated
6 years ago

Overview

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.

Detailed Description

The aim of this study is to assess the effects of adding 10 sessions of Cognitive Bias Modification (CBM) training, and goal planning using implementation intentions, to treatment as usual for adolescents with eating disorders. It is hypothesised that at baseline, participants will demonstrate cognitive biases in their attention towards rejecting/critical facial expressions (attentional bias), and in making negative resolutions of ambiguous social scenarios involving the risk of social rejection (interpretation bias). Young people receiving treatment for eating disorders will be recruited from participating child and adolescent eating disorder services in the United Kingdom. Information about the study, the main eligibility criteria and contact details for the researcher will also be advertised using flyers and social media platforms. Individuals from the community who express an interest in taking part will be screened using the Structured Clinical Interview for DSM-5 (SCID-5) disorders to screen for psychiatric disorders to determine their eligibility. Parental consent will be obtained for any participants under the age of 16. Eligible participants will be invited to meet the researcher for an initial visit, to provide consent and complete the baseline assessments. The baseline assessments will consist of a battery of questionnaires used to assess interpersonal sensitivity, mood, anxiety and eating disorder psychopathology, and computerised tasks to measure various aspects of social cognition including attention and interpretation biases. Following the baseline assessments, participants displaying attention and interpretation biases will be invited to take part in the next phase of the study. Participants randomised to receive the computerised training will meet with the researcher for a second visit, during which they will learn how to complete the training tasks, complete the first set of training modules and create plans involving exposure to the risk of social rejection with the researcher using the implementation intentions approach. Participants will be asked to complete the remaining training three times per week over three weeks (10 sessions in total) and will have weekly contact with the researcher to review adherence to planned behaviours using implementations intentions. Attention and interpretation biases will be assessed again at the end of the 3-week training and at 12 weeks follow-up. Questionnaire measures of interpersonal sensitivity, anxiety, depression and disorder psychopathology will also be administered at these two time points.

Registry
clinicaltrials.gov
Start Date
March 28, 2018
End Date
March 28, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 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
  • Inclusion Criteria for healthy volunteers
  • Fluency in English
  • Aged 13-17
  • Exclusion Criteria:
  • Current psychiatric diagnosis according to the DSM-5 (e.g. depression, anxiety)
  • History of a psychiatric disorder

Outcomes

Primary Outcomes

Change in positive interpretations of ambiguous social scenarios

Time Frame: End of intervention (3 weeks post-randomisation)

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

Change in attentional bias towards positively valenced faces

Time Frame: End of intervention (3 weeks post-randomisation)

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

Secondary Outcomes

  • 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 frequency of experiencing various symptoms of anxiety(End of intervention (3 weeks post-randomisation))
  • Change in self-reported interpersonal sensitivity(End of intervention (3 weeks post-randomisation))

Study Sites (1)

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