Social Information Processing in Adolescents With Eating Disorders
Primary Purpose
Eating Disorders in Adolescence
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Bias Modification
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders in Adolescence
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)
Sites / Locations
- King's College LondonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive Bias Modification (CBM) + Treatment as usual
Treatment as usual
Arm Description
Participants will receive access to a 3-week online training programme alongside their usual treatment.
Participants will continue to receive their usual treatment.
Outcomes
Primary Outcome Measures
Change in attentional bias towards positively valenced faces
Attentional probe assessment task and visual search task: reaction times (milliseconds) and accuracy
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).
Secondary Outcome Measures
Change in self-reported frequency of experiencing various symptoms of anxiety
Score on the Revised Child Anxiety and Depression Scale (RCADS). A higher score reflects a greater degree of symptom severity. Converted scores on the total scale and both sub-scales are divided into three scoring ranges, 1) Scores below 65 represent low severity 2) Scores between 65-70 represent medium severity and are on the borderline clinical threshold 3) Scores above 70 represent high severity and are above the clinical threshold.
Change in self-reported frequency of experiencing various symptoms of low mood
Score on the Revised Child Anxiety and Depression Scale (RCADS). A higher score reflects a greater degree of symptom severity. Converted scores on the total scale and both sub-scales are divided into three scoring ranges, 1) Scores below 65 represent low severity 2) Scores between 65-70 represent medium severity and are on the borderline clinical threshold 3) Scores above 70 represent high severity and are above the clinical threshold.
Change in Eating Disorder symptoms
Scores on the Eating Disorder Examination Questionnaire (EDE-Q). The EDE-Q is scored using a 7-point, forced-choice rating scale (0-6) with scores of 4 or higher indicative of clinical range. Subscale and global scores reflect the severity of eating disorder psychopathology. To obtain subscale scores, the ratings for the relevant items are added together and the sum is then divided by the total number of items forming the subscale. A "global" score is the sum of the four subscale scores divided by the number of subscales (i.e., four).
Change in self-reported interpersonal sensitivity
Scores on the Interpersonal Sensitivity Measure (IPSM). The IPSM is a 36-item measure. Each item is rated on a four-point scale, ranging from 4 (very like me) to 1 (very unlike me), with higher scores reflecting greater concerns about experiences involving the risk of social rejection. The scale generates a total score ranging from 36 to 144.
Full Information
NCT ID
NCT03563755
First Posted
May 9, 2018
Last Updated
August 30, 2019
Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust, South West London and St George's Mental Health NHS Trust, Ellern Mede Ridgeway, Ellern Mede Barnet
1. Study Identification
Unique Protocol Identification Number
NCT03563755
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
March 28, 2020 (Anticipated)
Study Completion Date
March 28, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust, South West London and St George's Mental Health NHS Trust, Ellern Mede Ridgeway, Ellern Mede Barnet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders in Adolescence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Bias Modification (CBM) + Treatment as usual
Arm Type
Experimental
Arm Description
Participants will receive access to a 3-week online training programme alongside their usual treatment.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Participants will continue to receive their usual treatment.
Intervention Type
Other
Intervention Name(s)
Cognitive Bias Modification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in attentional bias towards positively valenced faces
Description
Attentional probe assessment task and visual search task: reaction times (milliseconds) and accuracy
Time Frame
End of intervention (3 weeks post-randomisation)
Title
Change in positive interpretations of ambiguous social scenarios
Description
Sentence completion task and test trials from ambiguous scenarios training (frequencies of positive, neutral and negative interpretations).
Time Frame
End of intervention (3 weeks post-randomisation)
Secondary Outcome Measure Information:
Title
Change in self-reported frequency of experiencing various symptoms of anxiety
Description
Score on the Revised Child Anxiety and Depression Scale (RCADS). A higher score reflects a greater degree of symptom severity. Converted scores on the total scale and both sub-scales are divided into three scoring ranges, 1) Scores below 65 represent low severity 2) Scores between 65-70 represent medium severity and are on the borderline clinical threshold 3) Scores above 70 represent high severity and are above the clinical threshold.
Time Frame
End of intervention (3 weeks post-randomisation)
Title
Change in self-reported frequency of experiencing various symptoms of low mood
Description
Score on the Revised Child Anxiety and Depression Scale (RCADS). A higher score reflects a greater degree of symptom severity. Converted scores on the total scale and both sub-scales are divided into three scoring ranges, 1) Scores below 65 represent low severity 2) Scores between 65-70 represent medium severity and are on the borderline clinical threshold 3) Scores above 70 represent high severity and are above the clinical threshold.
Time Frame
End of intervention (3 weeks post-randomisation)
Title
Change in Eating Disorder symptoms
Description
Scores on the Eating Disorder Examination Questionnaire (EDE-Q). The EDE-Q is scored using a 7-point, forced-choice rating scale (0-6) with scores of 4 or higher indicative of clinical range. Subscale and global scores reflect the severity of eating disorder psychopathology. To obtain subscale scores, the ratings for the relevant items are added together and the sum is then divided by the total number of items forming the subscale. A "global" score is the sum of the four subscale scores divided by the number of subscales (i.e., four).
Time Frame
End of intervention (3 weeks post-randomisation)
Title
Change in self-reported interpersonal sensitivity
Description
Scores on the Interpersonal Sensitivity Measure (IPSM). The IPSM is a 36-item measure. Each item is rated on a four-point scale, ranging from 4 (very like me) to 1 (very unlike me), with higher scores reflecting greater concerns about experiences involving the risk of social rejection. The scale generates a total score ranging from 36 to 144.
Time Frame
End of intervention (3 weeks post-randomisation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Rowlands, BSc
Phone
0207 848 5980
Ext
5980
Email
katie.rowlands@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Cardi, PhD
Phone
0207 848 5972
Ext
5972
Email
valentina.cardi@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentina Cardi, PhD
Organizational Affiliation
King's College London
Official's Role
Study Director
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Rowlands
Phone
0207 848 5980
Ext
5980
Email
katie.rowlands@kcl.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Social Information Processing in Adolescents With Eating Disorders
We'll reach out to this number within 24 hrs