Measurement ReliabilityNCT04934631
Testing the Utility of a Competence Scale for CBT-ED Therapists
An observational study of Measurement Reliability and Clinician Competence, run by University of Sheffield.
Trial summary
This study aims to test the utility of a newly developed clinician competence scale for those delivering Cognitive-Behaviour Therapy for Eating Disorders (CBT-ED), specifically assessing the inter-rater reliability of the measure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Measurement Reliability, Clinician Competence
- What is being tested?
- Recording of CBT-ED session. and Assessment of CBT-ED clinician competence.
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Sep 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinicians delivering Cognitive-Behavioural Therapy for Eating Disorders (CBT-ED) will be assessed by independent raters using the Cognitive-Behavioural Therapy Scale for Eating Disorders (CBTS-ED). Clinicians will be delivering therapy in either NHS or Non-NHS organisations. A number of clinicians will be undergoing post-graduate diploma training in CBT-ED at either the University of Sheffield or UCL.
Therapist Inclusion Criteria:
- Qualified clinicians with a core National Health Service (NHS) profession currently undergoing post-graduate diploma training in CBT-ED at either the University of Sheffield or University College London (UCL), or;
- Qualified clinicians not on the CBT-ED training course but delivering CBT-ED
- Treating adult (18+ years) eating disorder patients
- Have a good understanding of written and verbal English
Patient Inclusion Criteria:
- Primary diagnosis of an eating disorder
- Accessing CBT-ED
- Aged 18+ years
- Have a good understanding of written and verbal English
- Have the capacity to provide written informed consent
Rater Inclusion Criteria:
- Specialists in the field of CBT-ED, or;
- Qualified clinicians who do not ordinarily work with eating disorder patients, or;
- CBT-ED trainees at Sheffield University or UCL, or;
- CBT-ED training course supervisors at Sheffield University or UCL
- Have a good understanding of written and verbal English
Therapist Exclusion Criteria:
- Non-qualified clinicians
- Non CBT-ED clinicians
- Clinicians only treating children or young people with eating disorders (aged 17 years or younger)
- Have little understanding of written and verbal English
Patient Exclusion Criteria:
- Non-eating disorder patients
- Eating disorder patients who are accessing treatment other than CBT
- Aged 17 years or younger
- Have little understanding of written and verbal English
- Lack the capacity to understand the project and provide written informed consent
Rater Exclusion Criteria:
- Little understanding of written and verbal English
About this study
Official title: Testing the Utility of a Clinician Competence Scale for Therapists Using Evidence-based Cognitive Behavioural Therapy With Eating Disorder Patients
This study aims to test the utility of a newly developed clinician competence scale for those delivering Cognitive-Behaviour Therapy for Eating Disorders (CBT-ED), specifically assessing the inter-rater reliability of the measure.
Read the detailed description
Cognitive-behavioural therapy for eating disorders (CBT-ED) is currently one of the NICE (2017) recommended treatments for anorexia nervosa and the only treatment recommended for bulimia nervosa, binge-eating disorder and other specified feeing and eating disorders. When clinicians adhere to evidence-based CBT-ED treatment manuals, CBT-ED has shown demonstrable levels of effectiveness in a range of eating disorders, comparable to outcomes in controlled research settings. A key component of CBT-ED found so effective in the treatment of eating disorders is a stronger focus on behavioural change tasks which is key for changing biased thinking. However, clinicians often drift from using behavioural change components and instead focus more on the cognitive aspects of therapy, or indeed drift away from treatment manuals substantially. Therefore, a suitable measure that can accurately assess how well a clinician is delivering the therapeutic competences that ensures patients are receiving evidence-based CBT-ED thus providing them with the best chance of reaching maximum recovery is important. Whilst numerous scales have been developed, none have yet been found suitable for eating disorders, as they do not have a strong focus on the key behavioural aspects of CBT-ED. Therefore, a team of clinical researchers developed the Cognitive Behaviour Therapy Scale for Eating Disorders (CBTS-ED). This pilot study will use CBT-ED therapy session audio-recordings, and different expert and non-expert raters to a) assess the inter-rater reliability of the CBTS-ED and b) assess whether the CBTS-ED can accurately detect improvement in competence among clinicians currently undergoing post-graduate diploma training in CBT-ED. The findings from this study will provide information about the reliability of the CBTS-ED scale and its possible future uses in predicting patient outcomes.
National Institute for Health and Care Excellence (2017). Eating disorders: recognition and treatment (NICE guideline NG69). Available at: https://www.nice.org.uk/guidance/ng69
- Conditions
- Measurement Reliability, Clinician Competence
- Being tested
- Recording of CBT-ED session., Assessment of CBT-ED clinician competence.
- Keywords
- CBT, CBT-ED, CBTS-ED, Competence, Eating Disorders
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of CBT-ED session.Other
Therapists will deliver treatment as usual (CBT-ED) to eating disorder patients. Therapy session will be audio recorded.
Assessment of CBT-ED clinician competence.Other
Independent raters will assess CBT-ED competence using the Cognitive-Behavioural Therapy Scale for Eating Disorders (CBTS-ED).
| Study group | Role | What they receive |
|---|---|---|
| CBT-ED trainees and therapists. | Qualified clinicians delivering CBT-ED throughout a variety of treatment settings, working with adult eating disorder patients. Clinicians will audio-record CBT-ED therapy sessions with their eating disorder patients. Receives: Other: Recording of CBT-ED session. | |
| Eating Disorder patients. | Adult (18+ years) eating disorder patients currently accessing CBT-ED from one of the CBT-ED therapists/trainees stated above. Patients will have one of their therapy sessions audio-recorded. Receives: Other: Recording of CBT-ED session. | |
| Raters/Judges. | Either experts or non-experts in the field of CBT-ED. Raters will use the CBTS-ED to assess clinician competence when listening to the therapy session audio-recordings. Receives: Other: Assessment of CBT-ED clinician competence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the CBTS-ED
Internal reliability of the CBTS-ED (Cronbach's Alpha) and the inter-rater reliability of the CBTS-ED (weighted Kappa statistic).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study startJan 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Unable to recruit NHS sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Measurement ReliabilityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Beard, University of Sheffield
- Investigators
- Glenn Waller, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934631
- Sponsor's protocol ID
- 298732
- Status last verified
- May 2024
- First submitted
- 14 Jun 2021
- Last updated
- 16 May 2024
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Utility of a Clinician Competence Scale for Therapists Using Evidence-based Cognitive Behavioural Therapy With Eating Disorder Patients
- ClinicalTrials.gov ID
- NCT04934631
- Acronym / sponsor ID
- 298732
- Conditions
- Measurement Reliability, Clinician Competence
- Keywords
- CBT, CBT-ED, CBTS-ED, Competence, Eating Disorders
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to recruit NHS sites
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 22 Jun 2021 (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 study aims to test the utility of a newly developed clinician competence scale for those delivering Cognitive-Behaviour Therapy for Eating Disorders (CBT-ED), specifically assessing the inter-rater reliability of the measure.
Detailed description
Cognitive-behavioural therapy for eating disorders (CBT-ED) is currently one of the NICE (2017) recommended treatments for anorexia nervosa and the only treatment recommended for bulimia nervosa, binge-eating disorder and other specified feeing and eating disorders. When clinicians adhere to evidence-based CBT-ED treatment manuals, CBT-ED has shown demonstrable levels of effectiveness in a range of eating disorders, comparable to outcomes in controlled research settings. A key component of CBT-ED found so effective in the treatment of eating disorders is a stronger focus on behavioural change tasks which is key for changing biased thinking. However, clinicians often drift from using behavioural change components and instead focus more on the cognitive aspects of therapy, or indeed drift away from treatment manuals substantially. Therefore, a suitable measure that can accurately assess how well a clinician is delivering the therapeutic competences that ensures patients are receiving evidence-based CBT-ED thus providing them with the best chance of reaching maximum recovery is important. Whilst numerous scales have been developed, none have yet been found suitable for eating disorders, as they do not have a strong focus on the key behavioural aspects of CBT-ED. Therefore, a team of clinical researchers developed the Cognitive Behaviour Therapy Scale for Eating Disorders (CBTS-ED). This pilot study will use CBT-ED therapy session audio-recordings, and different expert and non-expert raters to a) assess the inter-rater reliability of the CBTS-ED and b) assess whether the CBTS-ED can accurately detect improvement in competence among clinicians currently undergoing post-graduate diploma training in CBT-ED. The findings from this study will provide information about the reliability of the CBTS-ED scale and its possible future uses in predicting patient outcomes.
National Institute for Health and Care Excellence (2017). Eating disorders: recognition and treatment (NICE guideline NG69). Available at: https://www.nice.org.uk/guidance/ng69
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-ED trainees and therapists. | – | Other: Recording of CBT-ED session.Qualified clinicians delivering CBT-ED throughout a variety of treatment settings, working with adult eating disorder patients. Clinicians will audio-record CBT-ED therapy sessions with their eating disorder patients. |
| Eating Disorder patients. | – | Other: Recording of CBT-ED session.Adult (18+ years) eating disorder patients currently accessing CBT-ED from one of the CBT-ED therapists/trainees stated above. Patients will have one of their therapy sessions audio-recorded. |
| Raters/Judges. | – | Other: Assessment of CBT-ED clinician competence.Either experts or non-experts in the field of CBT-ED. Raters will use the CBTS-ED to assess clinician competence when listening to the therapy session audio-recordings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinicians delivering Cognitive-Behavioural Therapy for Eating Disorders (CBT-ED) will be assessed by independent raters using the Cognitive-Behavioural Therapy Scale for Eating Disorders (CBTS-ED). Clinicians will be delivering therapy in either NHS or Non-NHS organisations. A number of clinicians will be undergoing post-graduate diploma training in CBT-ED at either the University of Sheffield or UCL.
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 |
|---|---|---|
| Recording of CBT-ED session.Therapists will deliver treatment as usual (CBT-ED) to eating disorder patients. Therapy session will be audio recorded. | Other | CBT-ED trainees and therapists., Eating Disorder patients. |
| Assessment of CBT-ED clinician competence.Independent raters will assess CBT-ED competence using the Cognitive-Behavioural Therapy Scale for Eating Disorders (CBTS-ED). | Other | Raters/Judges. |
Primary outcome
Reliability of the CBTS-ED
Time frame: 12 months
Internal reliability of the CBTS-ED (Cronbach's Alpha) and the inter-rater reliability of the CBTS-ED (weighted Kappa statistic).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
Glenn Waller principal investigator
University of Sheffield
Questions about this trial
What is this clinical trial studying?
An observational study of Measurement Reliability and Clinician Competence, run by University of Sheffield.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the CBTS-ED (time frame: 12 months). 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 16 May 2024.