<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421443</url>
  </required_header>
  <id_info>
    <org_study_id>IPES/CB/2020</org_study_id>
    <nct_id>NCT04421443</nct_id>
  </id_info>
  <brief_title>Unified Protocol for Bariatric Surgery Candidates</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jorge Javier Osma López</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad de Zaragoza</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto de Investigación Sanitaria Aragón</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present pilot study with a multiple baseline experimental desing will verify the&#xD;
      feasibility and clinical utility of the Unified Protocol, applied in an online group format&#xD;
      in a mental health setting of the Spanish national health system to patients waiting for&#xD;
      bariatric surgery with diagnosis or symptoms of Emotional Disorders&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is currently becoming a serious global public health problem due to the high&#xD;
      prevalence and the large increase in recent years. This condition is associated with&#xD;
      different health problems, including physical and mental diseases. The presence of anxiety or&#xD;
      depression disorders among candidates for bariatric surgery it is very high and predicts&#xD;
      worse results. The present study aims to explore the feasibility and clinical usefulness of&#xD;
      an online group format application of the Unified Protocol, a transdiagnostic emotion-based&#xD;
      intervention for patients waiting for bariatric surgery with at least one emotional disorder&#xD;
      diagnosis or emotional symptoms.&#xD;
&#xD;
      We will conduct a pilot study with a repeated single case experimental design (multiple&#xD;
      baseline design) in a public mental health service. The sample will consist of 45&#xD;
      participants who will be randomized to three baseline conditions: 8, 12 or 15 evaluation days&#xD;
      before the intervention. Depression and anxiety symptoms and diagnostic criteria will be the&#xD;
      primary outcome measures. Secondary measures will include evaluation of affectivity,&#xD;
      personality traits, general fit, quality of life, and different body image and eating&#xD;
      outcomes. An analysis of treatment satisfaction will be also performed. Assessment points&#xD;
      include baseline, pre-treatment, post-treatment, and follow-ups every three months until two&#xD;
      years after post-treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 2023</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will know the baseline condition they have been assigned to: 3, 5 or 8 evaluation days before the intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mini International Neuropsychiatric Interview (MINI)</measure>
    <time_frame>Only before of the treatment to check inclusion criteria, an average of 3 months</time_frame>
    <description>This interview contains structured questions that evaluate major psychiatric disorders based on the Diagnostic and Statistical Manual of Mental Disorders</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Anxiety Inventory (BAI)</measure>
    <time_frame>Only before of the treatment to check inclusion criteria, an average of 3 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory (BDI-II)</measure>
    <time_frame>Only before of the treatment to check inclusion criteria, an average of 3 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Depression Severity and Impairment Scale (ODSIS)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Anxiety Severity and Impairment Scale (OASIS)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Affect Scale (PANAS)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NEO Five-Factor Inventory (NEO-FFI)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Index (QLI)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maladjustment Inventory (MI)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulties in Emotion Regulation Scale (DERS)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bulimic Investigatory Test Edinburgh (BITE)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Shape Questionnaire (BSQ)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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 &lt;81, slightly worried = 81-110, moderately worried = 111-140, extremely worried &gt;140.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Eating Scale (EES)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mensual Body Mass Index (BMI)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Treatment</measure>
    <time_frame>Through study completion, an average of 3 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Emotional Disorder</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>3 days before intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants have to complete a pre-treatment assessment (baseline) for 3 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 days before intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants have to complete a pre-treatment assessment (baseline) for 5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8 days before intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants have to complete a pre-treatment assessment (baseline) for 8 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Unified Protocol for Transdiagnostic Treatment of Emotional Disorders</intervention_name>
    <description>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.</description>
    <arm_group_label>3 days before intervention</arm_group_label>
    <arm_group_label>5 days before intervention</arm_group_label>
    <arm_group_label>8 days before intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being of a legal age&#xD;
&#xD;
          -  Being a bariatric surgery candidate&#xD;
&#xD;
          -  Presenting anxious or depressive symptomatology (subclinical symptoms with BDI-II and&#xD;
             BAI) or meeting the criteria for at least one emotional disorder (anxiety, mood and&#xD;
             related disorders) from the International Neuropsychiatric Interview (MINI)&#xD;
&#xD;
          -  Speaking Spanish or Catalan fluently&#xD;
&#xD;
          -  Committing to attend the sessions&#xD;
&#xD;
          -  Understanding and accepting the contents of the informed consent, expressed by signing&#xD;
             it&#xD;
&#xD;
          -  Having Internet to fulfill the protocol assessments online, and (8) being agree to&#xD;
             maintain the prescribed medication regimen (including dosage) during the evaluation&#xD;
             period, if any, and during treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a severe condition that would require to be prioritized for treatment, so that&#xD;
             an interaction between both interventions cannot be ruled out. These include a severe&#xD;
             mental disorder (bipolar disorder, personality disorder, schizophrenia, or an organic&#xD;
             mental disorder), suicide risk at the time of assessment, or substance use in the last&#xD;
             three months (excluding cannabis, coffee, and/or nicotine).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorge Osma, Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto de Investigación Sanitaria Aragón, Universidad de Zaragoza</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jorge Osma, Ph. D.</last_name>
    <phone>978645390</phone>
    <email>osma@unizar.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Instituto de investigación sanitaria de Aragón, universidad de Zaragoza</name>
      <address>
        <city>Teruel</city>
        <zip>44003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://ipes-group.com/</url>
    <description>IPES web (Investigation group)</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Instituto de Investigación Sanitaria Aragón</investigator_affiliation>
    <investigator_full_name>Jorge Javier Osma López</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Emotional Disorders</keyword>
  <keyword>Transdiagnostic</keyword>
  <keyword>Unified Protocol</keyword>
  <keyword>Bariatric Surgery</keyword>
  <keyword>Obesity</keyword>
  <keyword>Emotional Regulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Under request</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421443
org study id: IPES/CB/2020
nct id: NCT04421443
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: Single (Participant)
masking description: Participants will know the baseline condition they have been assigned to: 3, 5 or 8 evaluation days before the intervention.
measure: Mini International Neuropsychiatric Interview (MINI)
time frame: Only before of the treatment to check inclusion criteria, an average of 3 months
description: This interview contains structured questions that evaluate major psychiatric disorders based on the Diagnostic and Statistical Manual of Mental Disorders
measure: Beck Anxiety Inventory (BAI)
time frame: Only before of the treatment to check inclusion criteria, an average of 3 months
description: 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.
measure: Beck Depression Inventory (BDI-II)
time frame: Only before of the treatment to check inclusion criteria, an average of 3 months
description: 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.
measure: Overall Depression Severity and Impairment Scale (ODSIS)
time frame: Up to 24 months
description: 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.
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
time frame: Up to 24 months
description: 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.
measure: Positive and Negative Affect Scale (PANAS)
time frame: Up to 24 months
description: 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
measure: NEO Five-Factor Inventory (NEO-FFI)
time frame: Up to 24 months
description: 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
measure: Quality of Life Index (QLI)
time frame: Up to 24 months
description: 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
measure: Maladjustment Inventory (MI)
time frame: Up to 24 months
description: 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
measure: Difficulties in Emotion Regulation Scale (DERS)
time frame: Up to 24 months
description: 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
measure: EuroQol
time frame: Up to 24 months
description: 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
measure: Bulimic Investigatory Test Edinburgh (BITE)
time frame: Up to 24 months
description: 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.
measure: Body Shape Questionnaire (BSQ)
time frame: Up to 24 months
description: 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.
measure: Emotional Eating Scale (EES)
time frame: Up to 24 months
description: 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.
measure: Mensual Body Mass Index (BMI)
time frame: Up to 24 months
description: 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.
measure: Satisfaction with Treatment
time frame: Through study completion, an average of 3 months
description: 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.
arm group label: 3 days before intervention
arm group type: Active Comparator
description: Participants have to complete a pre-treatment assessment (baseline) for 3 days.
arm group label: 5 days before intervention
arm group type: Active Comparator
description: Participants have to complete a pre-treatment assessment (baseline) for 5 days.
arm group label: 8 days before intervention
arm group type: Active Comparator
description: Participants have to complete a pre-treatment assessment (baseline) for 8 days.
intervention type: Behavioral
intervention name: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
description: 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.
arm group label: 3 days before intervention
arm group label: 5 days before intervention
arm group label: 8 days before intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jorge Osma, Ph. D.
role: Principal Investigator
affiliation: Instituto de Investigación Sanitaria Aragón, Universidad de Zaragoza
last name: Jorge Osma, Ph. D.
phone: 978645390
email: osma@unizar.es
facility: 
country: Spain
url: https://ipes-group.com/
description: IPES web (Investigation group)
responsible party type: Sponsor-Investigator
investigator affiliation: Instituto de Investigación Sanitaria Aragón
investigator full name: Jorge Javier Osma López
investigator title: Principal Investigator
mesh term: Depression
mesh term: Mood Disorders
sharing ipd: Yes
ipd description: Under request