Barlow's unIfied Protocol for emoTional Eating (BITE): a Pre-post Design

Emotional Eating Clinical Trial

— BITE  

Official title:

Barlow's unIfied Protocol for emoTional Eating (BITE): a Pre-post Design

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05641350
• Other study ID #: IIBSP-BIT-2022-78
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Emotional Eating

Intervention

Behavioral:
• Barlow's Unified Protocol
Adaptation of the cognitive-behavioral Barlow's Unified Protocol for emotional eating pattern.

Locations

Country	Name	City	State
Spain	Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional eating score assessed by the Emotional eating sub-scale of the Dutch Eating Behavior Questionnaire (DEBQ-EE)		8 weeks