Emotional EatingBITENCT05641350
Barlow's unIfied Protocol for emoTional Eating (BITE): a Pre-post Design
A study testing Barlow's Unified Protocol in people with Emotional Eating, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
This study aims to evaluate the efficacy of a group intervention program, based on the Barlow's protocol, in patients with emotional eating with the aim of improving the emotional eating pattern. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Eating
- What is being tested?
- Barlow's Unified Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2022to 1 Dec 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients from eating behavior disorder outpatient clinics and psychiatric outpatient clinics.
- Age between 18 and 65 years.
- Score of more than 2.46 on the "emotional eating" subscale of the DEBQ scale
Who cannot join
- Diagnosis of active Eating Disorder, that is, without at least 6 months of symptomatic remission or that exceed the cut-off point on the EAT-26 scale.
- Patients with severe mental disorder with or without psychotic symptoms (schizophreniform disorders, bipolar spectrum disorders, major depression)
- Patients with some other medical disorder that presents with impulse dysregulation, such as epilepsy, frontal-type dementia...
- Patients with an IQ < 85
- Patients who do not give consent.
- Patients who do not understand or speak Spanish or Catalan.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
Barcelona
About this study
This study aims to evaluate the efficacy of a group intervention program, based on the Barlow's protocol, in patients with emotional eating with the aim of improving the emotional eating pattern.
The design is quasi-experimental pre-post with a control group (waiting list) and evaluation of the maintenance of the response after 6 months of the end of the program.
Includes outpatients from the Eating Disorders Unit and the Psychiatry Unit of a Hospital. A sample size of 26 participants is considered in the experimental group, and another 26 more in the control group.
- Conditions
- Emotional Eating
- Being tested
- Barlow's Unified Protocol
- Medical subject headings
- Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barlow's Unified ProtocolBehavioural
Adaptation of the cognitive-behavioral Barlow's Unified Protocol for emotional eating pattern.
| Study group | Role | What they receive |
|---|---|---|
| Emotional eating intervention | Experimental | Emotional eating intervention Receives: Behavioral: Barlow's Unified Protocol |
| Waiting list | No intervention | Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional eating score assessed by the Emotional eating sub-scale of the Dutch Eating Behavior Questionnaire (DEBQ-EE)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Dec 2022
- Primary completion1 Nov 2023
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional EatingStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641350
- Sponsor's protocol ID
- IIBSP-BIT-2022-78
- Acronym
- BITE
- Status last verified
- Mar 2023
- First submitted
- 16 Nov 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gawron LP, Rodriguez Clifford K, Ramirez Guillen A, Carceller-Sindreu M, Carmona Farres C, Del Mar Bonnin C, Portella MJ. Adapting Barlow's Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Overweight Adults: A Nonrandomized Controlled Feasibility Study. Int J Eat Disord. 2025 Sep;58(9):1747-1757. doi: 10.1002/eat.24474. Epub 2025 May 26.
PubMed 40418102
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barlow's unIfied Protocol for emoTional Eating (BITE): a Pre-post Design
- ClinicalTrials.gov ID
- NCT05641350
- Acronym / sponsor ID
- BITE / IIBSP-BIT-2022-78
- Conditions
- Emotional Eating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 7 Dec 2022 (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 evaluate the efficacy of a group intervention program, based on the Barlow's protocol, in patients with emotional eating with the aim of improving the emotional eating pattern.
The design is quasi-experimental pre-post with a control group (waiting list) and evaluation of the maintenance of the response after 6 months of the end of the program.
Includes outpatients from the Eating Disorders Unit and the Psychiatry Unit of a Hospital. A sample size of 26 participants is considered in the experimental group, and another 26 more in the control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional eating intervention | Experimental | Behavioral: Barlow's Unified ProtocolEmotional eating intervention |
| Waiting list | No intervention | –Waiting list |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients from eating behavior disorder outpatient clinics and psychiatric outpatient clinics.
- Age between 18 and 65 years.
- Score of more than 2.46 on the "emotional eating" subscale of the DEBQ scale
Key exclusion criteria (6 listed)
- Diagnosis of active Eating Disorder, that is, without at least 6 months of symptomatic remission or that exceed the cut-off point on the EAT-26 scale.
- Patients with severe mental disorder with or without psychotic symptoms (schizophreniform disorders, bipolar spectrum disorders, major depression)
- Patients with some other medical disorder that presents with impulse dysregulation, such as epilepsy, frontal-type dementia...
- Patients with an IQ < 85
- Patients who do not give consent.
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 |
|---|---|---|
| Barlow's Unified ProtocolAdaptation of the cognitive-behavioral Barlow's Unified Protocol for emotional eating pattern. | Behavioural | Emotional eating intervention |
Primary outcome
Emotional eating score assessed by the Emotional eating sub-scale of the Dutch Eating Behavior Questionnaire (DEBQ-EE)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 40418102Gawron LP, Rodriguez Clifford K, Ramirez Guillen A, Carceller-Sindreu M, Carmona Farres C, Del Mar Bonnin C, Portella MJ. Adapting Barlow's Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Overweight Adults: A Nonrandomized Controlled Feasibility Study. Int J Eat Disord. 2025 Sep;58(9):1747-1757. doi: 10.1002/eat.24474. Epub 2025 May 26.
- Individual participant dataSharing planned: Undecided
Related trials for Emotional Eating
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Recruiting
Just-in-Time Coping Prompts for Reactive Digital Behavior in College Students
Emotional Regulation, Alcohol Drinking in College
Recruiting
Readiness and Progress in Emotion Regulation Therapy
Rumination, Worry
Not yet recruiting
Unflavored Powdered Multivitamin in Children
Selective Eating, Emotional Dysregulation
RecruitingPhase 2/3
Food-Body-Mind Intervention (16 Weeks)
Mental Health Wellness, Emotional Problem
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barlow's Unified Protocol in people with Emotional Eating, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 inclusion and 6 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 5 Dec 2023. 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 Spain. 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?
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?
Emotional eating score assessed by the Emotional eating sub-scale of the Dutch Eating Behavior Questionnaire (DEBQ-EE) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05641350, which also lists 1 linked publication.
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 5 Dec 2023.