Unified Protocol for Bariatric Surgery Candidates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-12-31

Brief Summary

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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

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Detailed Description

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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

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Emotional Disorder Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants will know the baseline condition they have been assigned to: 3, 5 or 8 evaluation days before the intervention.

Study Groups

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3 days before intervention

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

Group Type ACTIVE_COMPARATOR

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type 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.

5 days before intervention

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

Group Type ACTIVE_COMPARATOR

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type 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.

8 days before intervention

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

Group Type ACTIVE_COMPARATOR

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No