Clinical trial NCT03563755: Social Information Processing in Adolescents With Eating Disorders
Official title: Social Information Processing in Adolescents With Eating Disorders: Implications for Theory and Clinical Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorders in Adolescence
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
name: South West London and St George's Mental Health NHS Trust
name: Ellern Mede Ridgeway
name: Ellern Mede Barnet
First posted: 2018-06-20
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria for patients with eating disorders

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

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
* Neurological condition (e.g. epilepsy)
* Severe visual impairment uncorrected with visual aids (eyewear)

Primary outcomes:
measure: Change in attentional bias towards positively valenced faces
timeFrame: End of intervention (3 weeks post-randomisation)
measure: Change in positive interpretations of ambiguous social scenarios
timeFrame: End of intervention (3 weeks post-randomisation)
Secondary outcomes:
measure: Change in self-reported frequency of experiencing various symptoms of anxiety
timeFrame: End of intervention (3 weeks post-randomisation)
measure: Change in self-reported frequency of experiencing various symptoms of low mood
timeFrame: End of intervention (3 weeks post-randomisation)
measure: Change in Eating Disorder symptoms
timeFrame: End of intervention (3 weeks post-randomisation)
measure: Change in self-reported interpersonal sensitivity
timeFrame: End of intervention (3 weeks post-randomisation)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Valentina Cardi, PhD
role: STUDY_DIRECTOR
References: