Emotional DisorderNCT04421443
Unified Protocol for Bariatric Surgery Candidates
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Emotional Disorder and Anxiety, run by Jorge Javier Osma López at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Disorder, Anxiety, Depression
- What is being tested?
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Instituto de investigación sanitaria de Aragón, universidad de Zaragoza
Teruel, 44003
About this study
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
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
Read the 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.
- Conditions
- Emotional Disorder, Anxiety, Depression
- Being tested
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Keywords
- Emotional Disorders, Transdiagnostic, Unified Protocol, Bariatric Surgery, Obesity, Emotional Regulation
- Medical subject headings
- Anxiety Disorders, Depression, Obesity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for Transdiagnostic Treatment of Emotional DisordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 days before intervention | Active comparator | Participants have to complete a pre-treatment assessment (baseline) for 3 days. Receives: 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. Receives: 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. Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months
Secondary outcomes (11)
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
Measured: Up to 24 months
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
Measured: Up to 24 months
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
Measured: Up to 24 months
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
Measured: Up to 24 months
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
Measured: Up to 24 months
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
Measured: Up to 24 months
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.
Measured: Up to 24 months
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.
Measured: Up to 24 months
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.
Measured: Up to 24 months
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.
Measured: Up to 24 months
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.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study startJun 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jorge Javier Osma López
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Universidad de Zaragoza
- Responsible party
- Sponsor-investigator, Jorge Javier Osma López, Instituto de Investigación Sanitaria Aragón
- Investigators
- Jorge Osma, Ph. D., Principal investigator, Instituto de Investigación Sanitaria Aragón, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421443
- Sponsor's protocol ID
- IPES/CB/2020
- Status last verified
- Feb 2023
- First submitted
- 26 May 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under request
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04421443
- Acronym / sponsor ID
- IPES/CB/2020
- Conditions
- Emotional Disorder, Anxiety, Depression
- Keywords
- Emotional Disorders, Transdiagnostic, Unified Protocol, Bariatric Surgery, Obesity, Emotional Regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Jorge Javier Osma LópezUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Universidad de Zaragoza
- Study start
- Jun 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| 3 days before intervention | Active comparator | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersParticipants have to complete a pre-treatment assessment (baseline) for 3 days. |
| 5 days before intervention | Active comparator | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersParticipants have to complete a pre-treatment assessment (baseline) for 5 days. |
| 8 days before intervention | Active comparator | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersParticipants have to complete a pre-treatment assessment (baseline) for 8 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified Protocol for Transdiagnostic Treatment of Emotional DisordersThis 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. | Behavioural | 3 days before intervention, 5 days before intervention, 8 days before intervention |
Primary outcome
Mini International Neuropsychiatric Interview (MINI)
Time frame: Only before of the treatment to check inclusion criteria, an average of 3 months
This interview contains structured questions that evaluate major psychiatric disorders based on the Diagnostic and Statistical Manual of Mental Disorders
Beck Anxiety Inventory (BAI)
Time frame: Only before of the treatment to check inclusion criteria, an average of 3 months
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.
Beck Depression Inventory (BDI-II)
Time frame: Only before of the treatment to check inclusion criteria, an average of 3 months
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.
Overall Depression Severity and Impairment Scale (ODSIS)
Time frame: Up to 24 months
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.
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Up to 24 months
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.
11 secondary outcomes
Positive and Negative Affect Scale (PANAS)
Time frame: Up to 24 months
NEO Five-Factor Inventory (NEO-FFI)
Time frame: Up to 24 months
Quality of Life Index (QLI)
Time frame: Up to 24 months
Maladjustment Inventory (MI)
Time frame: Up to 24 months
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Up to 24 months
EuroQol
Time frame: Up to 24 months
Bulimic Investigatory Test Edinburgh (BITE)
Time frame: Up to 24 months
Body Shape Questionnaire (BSQ)
Time frame: Up to 24 months
Emotional Eating Scale (EES)
Time frame: Up to 24 months
Mensual Body Mass Index (BMI)
Time frame: Up to 24 months
Satisfaction with Treatment
Time frame: Through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- IPES web (Investigation group)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Under request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Osma, Ph. D. principal investigator
Instituto de Investigación Sanitaria Aragón, Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Emotional Disorder and Anxiety, run by Jorge Javier Osma López at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Osma, Ph. D. (978645390, osma@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini International Neuropsychiatric Interview (MINI) (time frame: Only before of the treatment to check inclusion criteria, an average of 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.