Unified Protocol for Bariatric Surgery Candidates

NCT04421443 | Unknown

• 1 other identifier: IPES/CB/2020
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Emotional Disorder; Anxiety; Depression

Keywords

Emotional Disorders; Transdiagnostic; Unified Protocol; Bariatric Surgery; Obesity; Emotional Regulation

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (11)

• Positive and Negative Affect Scale (PANAS)

  Up to 24 months

• NEO Five-Factor Inventory (NEO-FFI)

  Up to 24 months

• Quality of Life Index (QLI)

  Up to 24 months

• Maladjustment Inventory (MI)

  Up to 24 months

• Difficulties in Emotion Regulation Scale (DERS)

  Up to 24 months

Study Arms (3)

3 days before intervention

ACTIVE COMPARATOR

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

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

5 days before intervention

ACTIVE COMPARATOR

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

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

8 days before intervention

ACTIVE COMPARATOR

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

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Interventions

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders BEHAVIORAL

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.

3 days before intervention; 5 days before intervention; 8 days before intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jorge Javier Osma López: lead
• Instituto de Salud Carlos III: collaborator
• Universidad de Zaragoza: collaborator

Study Sites (1)

Instituto de investigación sanitaria de Aragón, universidad de Zaragoza

Teruel, 44003, Spain

Location

Related Links

• IPES web (Investigation group)

MeSH Terms

Conditions

Anxiety Disorders; Depression; Obesity; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior

Study Officials

• Jorge Osma, Ph. D.

  Instituto de Investigación Sanitaria Aragón, Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Osma, Ph. D.

CONTACT

978645390; osma@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will know the baseline condition they have been assigned to: 3, 5 or 8 evaluation days before the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 9, 2020
• Study Start: June 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)