Clinical trial NCT04421443: Unified Protocol for Bariatric Surgery Candidates
Official title: Feasibility and Clinical Usefulness of the Unified Protocol in Online Group Format for Bariatric Surgery Candidates: Study Protocol for a Multiple Baseline Experimental Design
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Disorder
Anxiety
Depression
Keywords: Emotional Disorders
Transdiagnostic
Unified Protocol
Bariatric Surgery
Obesity
Emotional Regulation
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Universidad de Zaragoza
First posted: 2020-06-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the present investigation, all consecutive patients who have been selected to undergo bariatric surgery and present anxiety or depressive symptoms or at least one diagnosis of emotional disorder, are asked to participate. Once inclusion criteria are accomplished, each patient will be randomly assigned to one of the multiple baseline groups: 3, 5 or 8 evaluation days before the intervention. The study includes eleven assessment points (baseline, pre-treatment, post-treatment and eight follow-ups, one every three months until two years after treatment completion).
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Mini International Neuropsychiatric Interview (MINI)
timeFrame: Only before of the treatment to check inclusion criteria, an average of 3 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: Only before of the treatment to check inclusion criteria, an average of 3 months
measure: Beck Depression Inventory (BDI-II)
timeFrame: Only before of the treatment to check inclusion criteria, an average of 3 months
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Up to 24 months
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: Up to 24 months
measure: NEO Five-Factor Inventory (NEO-FFI)
timeFrame: Up to 24 months
measure: Quality of Life Index (QLI)
timeFrame: Up to 24 months
measure: Maladjustment Inventory (MI)
timeFrame: Up to 24 months
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Up to 24 months
measure: EuroQol
timeFrame: Up to 24 months
measure: Bulimic Investigatory Test Edinburgh (BITE)
timeFrame: Up to 24 months
measure: Body Shape Questionnaire (BSQ)
timeFrame: Up to 24 months
measure: Emotional Eating Scale (EES)
timeFrame: Up to 24 months
measure: Mensual Body Mass Index (BMI)
timeFrame: Up to 24 months
measure: Satisfaction with Treatment
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Teruel
country: Spain
facility: Instituto de investigación sanitaria de Aragón, universidad de Zaragoza
Study officials:
affiliation: Instituto de Investigación Sanitaria Aragón, Universidad de Zaragoza
name: Jorge Osma, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: