Unified Protocol for Bariatric Surgery Candidates

Depression Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04421443
• Other study ID #: IPES/CB/2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Instituto de Investigación Sanitaria Aragón
• Contact: Jorge Osma, Ph. D.
• Phone: 978645390
• Email: osma[@]unizar.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Depression
• Emotional Disorder
• Mood Disorders

Intervention

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.

Locations

Country	Name	City	State
Spain	Instituto de investigación sanitaria de Aragón, universidad de Zaragoza	Teruel

Sponsors (3)

Lead Sponsor	Collaborator
Jorge Javier Osma López	Instituto de Salud Carlos III, Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini International Neuropsychiatric Interview (MINI)	This interview contains structured questions that evaluate major psychiatric disorders based on the Diagnostic and Statistical Manual of Mental Disorders	Only before of the treatment to check inclusion criteria, an average of 3 months
Primary	Beck Anxiety Inventory (BAI)	The BAI is composed of 21 items that evaluate anxiety symptoms. Responses use a 4-point Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score can range from 0 to 63. Higher scores are indicative of greater severity and functional impairment as a result of anxious symptoms.	Only before of the treatment to check inclusion criteria, an average of 3 months
Primary	Beck Depression Inventory (BDI-II)	It consists of 21 items, each with four different statements that reflect an increase in the degree of depression. A score of 0 indicates the absence of depressive symptoms and 3 reflects the most severe levels of depression. The scale has a 0-to-63 range. Higher scores are indicative of greater severity and functional impairment as a result of depressive symptoms.	Only before of the treatment to check inclusion criteria, an average of 3 months
Primary	Overall Depression Severity and Impairment Scale (ODSIS)	Consist of five items that evaluate the frequency and the intensity of depressive symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4. Higher scores are indicative of greater severity and functional impairment as a result of depressive symptoms.	Up to 24 months
Primary	Overall Anxiety Severity and Impairment Scale (OASIS)	Consist of five items that evaluate the frequency and the intensity of anxious symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4. Higher scores are indicative of greater severity and functional impairment as a result of anxious symptoms.	Up to 24 months
Secondary	Positive and Negative Affect Scale (PANAS)	It consists of 20 items that measure both positive and negative affect, 10 items for each dimension. Each item is rated on a 5-point Likert scale ranging from 1 (Not at all, very slightly) to 5 (Extremely). The higher the score in each of the dimensions, the greater the affect evaluated	Up to 24 months
Secondary	NEO Five-Factor Inventory (NEO-FFI)	This scale contains 60 items that provide a quick and overall measurement of the five major personality factors. The responses are rated on a 5-point Likert scale ranging from 0 (Strongly agree) to 4 (Strongly disagree). The higher the score in each of the dimensions, the higher the tendency toward that personality factor	Up to 24 months
Secondary	Quality of Life Index (QLI)	It contains 10 items that are rated on a 10-point Likert scale ranging from 1 (Poor) to 10 (Excellent). The higher the score, the higher the quality of life	Up to 24 months
Secondary	Maladjustment Inventory (MI)	This scale reflects the extent to which the person's current problems are affecting the different areas of their daily life, which are scored on a 6-point Likert scale ranging from 0 (not at all ) to 5 (Very severe). The higher the score, the greater the interference of current problems in the person's life	Up to 24 months
Secondary	Difficulties in Emotion Regulation Scale (DERS)	This scale includes 28 items rated on a 5-point Likert scale ranging from 1 (almost never/0-10% of the time) to 5 (almost always/90-100% of the time). The higher the total score, the higher the emotional dysregulation	Up to 24 months
Secondary	EuroQol	It is a generic instrument that will be use to measure health-related quality of life. Have 5 dimensions (mobility, personal care, daily activities, pain and anxiety/depression), and a general state of health perceived by means of a visual analog scale	Up to 24 months
Secondary	Bulimic Investigatory Test Edinburgh (BITE)	It is a self-report questionnaire used to evaluate the presence and severity of bulimic symptomatology, and cognitive and emotional signs and symptoms associated with binge eating. The total of score for all questions will give you a symptom score of 15 or above indicates that you have a lot of the thoughts and attitudes consistent with an eating disorder.	Up to 24 months
Secondary	Body Shape Questionnaire (BSQ)	It is a self-applied questionnaire which is used to evaluate fear of putting on weight, feelings of low self-esteem because of one's appearance, the desire to lose weight and body dissatisfaction. The scores are classified in 4 categories: not worried about body shape <81, slightly worried = 81-110, moderately worried = 111-140, extremely worried >140.	Up to 24 months
Secondary	Emotional Eating Scale (EES)	It is a 25-item self-report measure that assesses a person's tendency to cope with emotions through food. Each of the 25 items evaluates a different emotion through specific adjectives. The adjectives are valued in a 5-point Likert-type format that assesses the relationship between the emotion and the intensity of the desire to eat it causes. It is scored on a scale of 0 to 4: 0-I don't feel like eating; 4-I have a desire to eat very strong. Higher scores are indicative of a greater tendency to regulate emotions through diet.	Up to 24 months
Secondary	Mensual Body Mass Index (BMI)	Body mass index (BMI) is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres. For most adults, an ideal BMI is in the 18.5 to 24.9 range. If the BMI is for below 18.5 - is in the underweight range; between 18.5 and 24.9: you are in the healthy weight range; between 25 and 29.9 - you are in the overweight range; between 30 and 39.9 - you are in the obesity range.	Up to 24 months
Secondary	Satisfaction with Treatment	This ad hoc questionnaire assesses participants' opinion of the treatment received, to what extent it has helped participants adaptively regulate emotions, and which techniques have most influenced the regulation of their emotions. Higher scores on the questionnaire show greater satisfaction towards the treatment received.	Through study completion, an average of 3 months

External Links

•   IPES web (Investigation group)