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

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 Overview

• Status: Active, not recruiting
• Conditions: Emotional Eating
• Intervention / Treatment: Behavioral: Barlow's Unified Protocol

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotional eating intervention	Behavioral: Barlow's Unified Protocol; Adaptation of the cognitive-behavioral Barlow's Unified Protocol for emotional eating pattern.
No Intervention: Waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Emotional eating score assessed by the Emotional eating sub-scale of the Dutch Eating Behavior Questionnaire (DEBQ-EE)	8 weeks

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IIBSP-BIT-2022-78

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No