Eating Disorders in AdolescenceNCT03563755
Social Information Processing in Adolescents With Eating Disorders
A study testing Cognitive Bias Modification in people with Eating Disorders in Adolescence, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders in Adolescence
- What is being tested?
- Cognitive Bias Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2018to 28 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Fluency in English
- Aged 13-17
- With an eating disorder diagnosis according to the DSM-5
- Fluency in English
- Aged 13-17
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE5 8AF
Katie Rowlands, 0207 848 5980 ext. 5980, katie.rowlands@kcl.ac.uk
About this study
Official title: Social Information Processing in Adolescents With Eating Disorders: Implications for Theory and Clinical Practice
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.
Read the 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
- Being tested
- Cognitive Bias Modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Bias ModificationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Bias Modification (CBM) + Treatment as usual | Experimental | Participants will receive access to a 3-week online training programme alongside their usual treatment. Receives: Other: Cognitive Bias Modification |
| Treatment as usual | No intervention | Participants will continue to receive their usual treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in attentional bias towards positively valenced faces
Attentional probe assessment task and visual search task: reaction times (milliseconds) and accuracy
Measured: 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).
Measured: End of intervention (3 weeks post-randomisation)
Secondary outcomes (4)
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.
Measured: End of intervention (3 weeks post-randomisation)
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.
Measured: End of intervention (3 weeks post-randomisation)
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).
Measured: End of intervention (3 weeks post-randomisation)
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.
Measured: End of intervention (3 weeks post-randomisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start28 Mar 2018
- Primary completion28 Mar 2020 (estimated)
- Study completion28 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Disorders in AdolescenceStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Valentina Cardi, PhD, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563755
- Sponsor's protocol ID
- 229005
- Status last verified
- Aug 2019
- First submitted
- 9 May 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Information Processing in Adolescents With Eating Disorders: Implications for Theory and Clinical Practice
- ClinicalTrials.gov ID
- NCT03563755
- Acronym / sponsor ID
- 229005
- Conditions
- Eating Disorders in Adolescence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- 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
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 28 Mar 2020 (estimated)
- Study completion
- 28 Mar 2020 (estimated)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Bias Modification (CBM) + Treatment as usual | Experimental | Other: Cognitive Bias ModificationParticipants will receive access to a 3-week online training programme alongside their usual treatment. |
| Treatment as usual | No intervention | –Participants will continue to receive their usual treatment. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Fluency in English
- Aged 13-17
- With an eating disorder diagnosis according to the DSM-5
- Fluency in English
- Aged 13-17
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Bias ModificationCBM-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. | Other | Cognitive Bias Modification (CBM) + Treatment as usual |
Primary outcome
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
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).
4 secondary outcomes
Change in self-reported frequency of experiencing various symptoms of anxiety
Time frame: End of intervention (3 weeks post-randomisation)
Change in self-reported frequency of experiencing various symptoms of low mood
Time frame: End of intervention (3 weeks post-randomisation)
Change in Eating Disorder symptoms
Time frame: End of intervention (3 weeks post-randomisation)
Change in self-reported interpersonal sensitivity
Time frame: End of intervention (3 weeks post-randomisation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina Cardi, PhD study director
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Bias Modification in people with Eating Disorders in Adolescence, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katie Rowlands, BSc (0207 848 5980 ext. 5980, katie.rowlands@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in attentional bias towards positively valenced faces (time frame: End of intervention (3 weeks post-randomisation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.