NCT04421443

Unified Protocol for Bariatric Surgery Candidates

Feasibility and Clinical Usefulness of the Unified Protocol in Online Group Format for Bariatric Surgery Candidates: Study Protocol for a Multiple Baseline Experimental Design

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Jorge Javier Osma López · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present pilot study with a multiple baseline experimental desing will verify the feasibility and clinical utility of the Unified Protocol, applied in an online group format in a mental health setting of the Spanish national health system to patients waiting for bariatric surgery with diagnosis or symptoms of Emotional Disorders

Detailed description

Obesity is currently becoming a serious global public health problem due to the high prevalence and the large increase in recent years. This condition is associated with different health problems, including physical and mental diseases. The presence of anxiety or depression disorders among candidates for bariatric surgery it is very high and predicts worse results. The present study aims to explore the feasibility and clinical usefulness of an online group format application of the Unified Protocol, a transdiagnostic emotion-based intervention for patients waiting for bariatric surgery with at least one emotional disorder diagnosis or emotional symptoms. We will conduct a pilot study with a repeated single case experimental design (multiple baseline design) in a public mental health service. The sample will consist of 45 participants who will be randomized to three baseline conditions: 8, 12 or 15 evaluation days before the intervention. Depression and anxiety symptoms and diagnostic criteria will be the primary outcome measures. Secondary measures will include evaluation of affectivity, personality traits, general fit, quality of life, and different body image and eating outcomes. An analysis of treatment satisfaction will be also performed. Assessment points include baseline, pre-treatment, post-treatment, and follow-ups every three months until two years after post-treatment.

Conditions

• Emotional Disorder
• Anxiety
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Unified Protocol for Transdiagnostic Treatment of Emotional Disorders	This intervention focuses on a wide range of emotional psychopathology, allowing care for comorbid disorders and subclinical or unspecified symptoms, which reduces treatment times and costs, and improves response to treatment. The intervention will be carried out in an online-group format. For ethical reasons, if any of the patients feel uncomfortable during the study with the online-group format, will may leave the group and receive individual attention. The study plans follow-ups every three months until two years after post-treatment, all of them will be conducted online.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-06-09
• Last updated: 2023-03-01

Locations

1 site across 1 country: Spain