Social Information Processing in Adolescents With Eating Disorders

NCT ID: NCT03563755

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-28
• Study Completion Date: 2020-03-28

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.

Conditions

Eating Disorders in Adolescence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Bias Modification (CBM) + Treatment as usual

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

Group Type: EXPERIMENTAL

Cognitive Bias Modification

Intervention Type: 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.

Treatment as usual

Participants will continue to receive their usual treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Bias Modification

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Fluency in English
• Aged 13-17

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

• 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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role: collaborator

South West London and St George's Mental Health NHS Trust

OTHER

Sponsor Role: collaborator

Ellern Mede Ridgeway

UNKNOWN

Sponsor Role: collaborator

Ellern Mede Barnet

UNKNOWN

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valentina Cardi, PhD

Role: STUDY_DIRECTOR

King's College London

Locations

King's College London

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Katie Rowlands, BSc

Role: CONTACT

katie.rowlands@kcl.ac.uk

0207 848 5980 ext. 5980

Valentina Cardi, PhD

Role: CONTACT

valentina.cardi@kcl.ac.uk

0207 848 5972 ext. 5972

Facility Contacts

Katie Rowlands

Role: primary

katie.rowlands@kcl.ac.uk

0207 848 5980 ext. 5980

Other Identifiers

229005

Identifier Type: -

Identifier Source: org_study_id