Unified Protocol for Bariatric Surgery Candidates

Jorge Javier Osma López

Status: Not yet enrolling

Conditions: Emotional Disorder; Depression; Anxiety

Treatments: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Study type: Interventional

Funder types: Other

Identifiers

NCT04421443

IPES/CB/2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being of a legal age
• Being a bariatric surgery candidate
• Presenting anxious or depressive symptomatology (subclinical symptoms with BDI-II and BAI) or meeting the criteria for at least one emotional disorder (anxiety, mood and related disorders) from the International Neuropsychiatric Interview (MINI)
• Speaking Spanish or Catalan fluently
• Committing to attend the sessions
• Understanding and accepting the contents of the informed consent, expressed by signing it
• Having Internet to fulfill the protocol assessments online, and (8) being agree to maintain the prescribed medication regimen (including dosage) during the evaluation period, if any, and during treatment

Exclusion criteria

• Having a severe condition that would require to be prioritized for treatment, so that an interaction between both interventions cannot be ruled out. These include a severe mental disorder (bipolar disorder, personality disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance use in the last three months (excluding cannabis, coffee, and/or nicotine).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

3 days before intervention

Active Comparator group

Description:

Participants have to complete a pre-treatment assessment (baseline) for 3 days.

Treatment:

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

5 days before intervention

Active Comparator group

Description:

Participants have to complete a pre-treatment assessment (baseline) for 5 days.

Treatment:

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

8 days before intervention

Active Comparator group

Description:

Participants have to complete a pre-treatment assessment (baseline) for 8 days.

Treatment:

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders