BITE: Is a study delivering cognitive behavioural therapy to treat eating disorders in the workplace possible?
| ISRCTN | ISRCTN45943700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45943700 |
| Secondary identifying numbers | BSREC 152/20-21 |
- Submission date
- 06/12/2021
- Registration date
- 25/01/2022
- Last edited
- 20/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Around 700,000 people in the UK struggle with an eating disorder, with extremely long waiting lists for treatment within healthcare settings. Common symptoms can include binge eating, restrictive eating, or compensatory behaviours to get “rid” of food (e.g. vomiting or laxatives). Symptoms such as these can significantly impact peoples’ lives, causing problems with mood, energy levels, social relationships and work. Mental health problems are the leading cause of sickness absence in workers and affect one in six workers each year. The aim of this study is to see if a brief therapy for eating disorders (cognitive-behavioural therapy [CBT-T]) is helpful for employees in the workplace (i.e a non-health setting). The researchers also hope to see how employees mood and productivity might be improved following its completion.
Who can participate?
Adults employed in the Midlands with a body mass index (BMI) of 18.5 kg/m² or over who might be avoiding food due to worries about losing control of eating or weight, who might be very worried or distressed about their body shape, weight and size, without a diagnosis of anorexia nervosa, who are not in their third trimester of pregnancy
What does the study involve?
CBT-T is a brief, ten-session therapy for symptoms of eating disorders in non-underweight individuals, based on Cognitive Behavioural Therapy. It is split into several phases which include:
1. Getting into a regular, healthy eating routine and tackling anxiety
2. Changing beliefs about food
3. Learning to tackle the emotions that drive eating problems
4. Normalising body image and strengthening body acceptance
5. Making sure that you stay well
The trial will offer employees access to up to 10 1-hour weekly therapy sessions with a specially trained therapist, together with two follow-up sessions 1 and 3 months later. All therapy sessions will be delivered remotely by video call.
What are the possible benefits and risks of participating?
CBT-T is much shorter (10 sessions) than the standard CBT for eating disorders (20+ sessions) and has been shown to be equally as effective in healthcare settings. It may also help to reduce any anxiety and other emotional concerns. Whilst the researchers cannot guarantee recovery, if participants engage fully with CBT-T then they have a stronger chance of a full recovery and being able to get on with their lives.
As with all therapy, participants may experience some discomfort when talking about their experiences. They may also experience a natural increase in anxiety when trying out new behaviour patterns. Participants will be fully supported by their therapist throughout the trial and can share any concerns with them.
Where is the study run from?
WMG, University of Warwick (UK)
When is the study starting and how long is it expected to run for?
June 2021 to August 2022
Who is funding the study?
Midlands Engine (UK)
Who is the main contact?
1. Charlotte Kershaw, Charlotte.Kershaw@warwick.ac.uk
2. Dr Carla Toro, Carla.Toro@warwick.ac.uk
Contact information
Scientific
University of Warwick
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)24 765 74463 |
|---|---|
| c.meyer@warwick.ac.uk |
Public
University of Warwick
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)24 76572566 |
|---|---|
| charlotte.kershaw@warwick.ac.uk |
Scientific
University of Warwick
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)24 76572566 |
|---|---|
| carla.toro@warwick.ac.uk |
Study information
| Study design | Single-centre single-group pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 40767 PIS v2.0 01Oct2021.pdf |
| Scientific title | A feasibility study of the delivery of Brief Individual Treatment for Eating Disorders (BITE) in the workplace |
| Study acronym | BITE |
| Study objectives | It is hypothesised that recruitment to and acceptability of cognitive-behavioural therapy (CBT-T) in the workplace will be comparable with the health setting. The preliminary effectiveness of the intervention within this setting will be tested using measures of eating pathology, anxiety and depression, and work engagement. |
| Ethics approval(s) | Approved 28/09/2021, Biomedical and Scientific Research Ethics Committee (Kirby Corner Road, Coventry, CV4 8UW, UK; +44 24 765 73123; BSREC@warwick.ac.uk), ref: BSREC 152/20-21 |
| Health condition(s) or problem(s) studied | Eating disorders |
| Intervention | All participants who consent to this trial will be offered the CBT-T intervention facilitated by a therapist via video call. CBT-T consists of 10 weekly sessions lasting 45 to 60 minutes, plus two follow-up sessions at 1 and 3 months post-intervention. The weekly sessions are structured around five sequential phases: Phase 1 - education, nutrition and exposure with response prevention Phase 2 - behavioural experiments and cognitive restructuring relating to food Phase 3 - exposure and cognitive restructuring relating to emotions Phase 4 - approaches to body image Phase 5 - relapse prevention |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Recruitment success is measured by number of participants who have consented to the full trial within 3 months of recruitment opening 2. Attrition is measured via % retention of participants through all assessments over the 10 weekly sessions and 2 follow up sessions 3. Study retention is measured through the percentage of participant attendance of all therapy sessions |
| Secondary outcome measures | 1. Eating disorder symptoms measured using: 1.1. ED-15 at sessions 1-10 and post-intervention at 1 and 3 months 1.2. Eating Disorder Diagnostic Scale (EDDS) at baseline 1.3. Eating Disorder Examination Questionnaire at sessions 1, 4, 10 and post-intervention at 1 and 3 months 2. Mood disorder symptoms measured using the Patient Health Questionnaire-9 and Generalised Anxiety Disorder-7 at sessions 1, 4, 10 and post-intervention at 1 and 3 months 3. Work productivity measured through the Work Productivity and Activity Impairment: General Health v2.0 at baseline, session 10 and post-intervention at 1 and 3 months |
| Overall study start date | 01/06/2021 |
| Completion date | 12/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 47 |
| Key inclusion criteria | 1. Able to give informed consent 2. English speaking 3. ≥18 years of age 4. In employment 5. Food avoidance due to concern about losing control of eating and weight 6. Concern or distress about body weight, shape or size |
| Key exclusion criteria | 1. Diagnosis of anorexia nervosa 2. Body mass index <18.5 kg/m² 3. In the third trimester of pregnancy 4. Current suicidal ideation |
| Date of first enrolment | 05/10/2021 |
| Date of final enrolment | 04/01/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Coventry
CV4 7AL
United Kingdom
Sponsor information
University/education
Kirby Corner Road
Coventry
CV4 8UW
England
United Kingdom
| Phone | +44 (0)24 765 73123 |
|---|---|
| BSREC@warwick.ac.uk | |
| Website | http://www2.warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 08/09/2022: Planned publication in the International Journal of Eating Disorders (IJED). Protocol already published by IJED as a Registered Report 1 (https://pubmed.ncbi.nlm.nih.gov/35289953/). Results from the trial will be submitted as a Registered Report 2 in October 2022. Previous publication and dissemination plan: Planned publication in high-impact peer-reviewed journals e.g. International Journal of Eating Disorders. Protocol already submitted to the International Journal of Eating Disorders as a Registered Report 1 and corrections made after an initial round of peer-review. Results from the trial will be submitted as a Registered Report 2 in October 2022. |
| IPD sharing plan | Participant-level (raw) data will be available upon request. Requests for data should go to the corresponding author for the published protocol, Dr Carla Toro (carla.toro@warwick.ac.uk). Raw scores from measures listed in the protocol, and objective data collected during clinical contacts will be available following the publication of the final report for a period of 10 years. The data will be shared with anyone by email upon reasonable request (e.g. for related research purposes). Participants have consented to the use of their anonymised data for future research. Shared data will be fully anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 01/10/2021 | 20/12/2021 | No | Yes |
| Protocol article | 15/03/2022 | 08/09/2022 | Yes | No | |
| Results article | 19/04/2023 | 20/04/2023 | Yes | No |
Additional files
Editorial Notes
20/04/2023: Publication reference added.
09/09/2022: IPD sharing statement added.
08/09/2022: The following changes were made to the trial record:
1. Publication reference and total final enrolment added.
2. The overall trial end date was changed from 30/09/2022 to 12/08/2022.
3. Publication and dissemination plan and IPD sharing statement updated.
20/12/2021: Trial's existence confirmed by The University of Warwick
