Relative


Participants' evaluation and selection will be carried out by the clinical psychologists and psychiatrists of the mental health unit of the Regional Hospital of Vinaròs (Castellón). The clinical psychologists who will participate in this trial will be in charge of collecting all the information from the participants (alphanumeric codes assigned to the participants will be entered to safeguard their anonymity). The coded information will be given to the author J.O. to introduce it in the database and then, returned to the center.

Participants who have received the approval for BS by the multidisciplinary health team and also have met the inclusion criteria by the clinician (see "Eligibility criteria" section), will be invited to participate in the study through an informative document. They will also be provided with confidentiality and informed consent documents. After accepting to participate, an email will be sent to participants with a link through which they will be able to complete the pre-treatment evaluation on the Qualtrics survey platform [45]. Then, they will be informed by phone of the experimental condition to which they will have been randomly assigned, which may be 8, 12, or 15 days baseline assessment, and they will then complete online the baseline assessment protocol on the same platform [45]. Randomization to the different baselines will be done with randomizer software (www.randomizer.org). Randomization will be performed by a researcher unrelated to the

<sup>-</sup> Clearly unfavorable family environment

study using the computer-generated sequence mentioned. In the program, the researcher will generate one set of 60 numbers, which will have a one to three range. Participants will be randomly assigned to the 8, 12 or 15 baseline days.

The baseline and psychological intervention will be conducted between the period of acceptance for BS and the BS implementation, that last approximately one year in public health settings. The intervention will be carried out in an online group format through the Cisco Webex platform. The UP will be applied in twelve weekly 2-h online group sessions. To comply with the experimental design of the multiple baseline, when each participant completes the baseline evaluation, they will receive the first online session in individual format (to receive the first session in stages), then they will continue with the second session and the rest of the treatment in group format. The content of each session is shown in Table 2. Participants will receive the therapy support manual [11]. The online group will consist of five to eight participants, one therapist (V.F.-G.), and one co-therapist (A.Q.-O.). For ethical reasons, if any of the patients feel uncomfortable during the study with the online group format, they may leave the group and receive individual onsite attention (treatment as usual). In this case, the content and estimated number of sessions will be the same, although the frequency will be stipulated by the mental health unit depending on its possibilities.



The study plans to conduct a follow-up assessment every three months until two years after treatment completion. All follow-ups will be conducted online. Considering the time interval of the baseline, the psychological intervention and the BS procedure, the two first follow-ups (three and six months after intervention) will be conducted before BS, and the rest will be conducted after BS. In addition, at the baseline and during treatment, the participants must fill out an online survey made up of 14 questions that will ask about the intensity of the emotions of happiness, sadness, anxiety, other emotions, di fficulties in emotion regulation, body image, and emotional eating. Through this weekly evaluation, we expect to observe how the participants evolve in the di fferent variables throughout the di fferent treatment modules.

## *2.3. Eligibility Criteria*

The inclusion criteria for participation in the project will be: (1) being over 18 years of age; (2) being a BS candidate; (3) presenting anxious or depressive symptomatology (moderate scores on the Beck Depression Inventory-II [46,47] and/or Beck Anxiety Inventory [48,49]) or meeting the criteria for at least one ED (anxiety, mood, and related disorders) on the International Neuropsychiatric Interview (MINI; [50]); (4) speaking Spanish or Catalan fluently; (5) committing to attend the sessions; (6) understanding and accepting the contents of the informed consent, expressed by signing it; (7) having Internet to fulfill the protocol assessments and to participate in the online intervention and (8) agreeing to maintain the prescribed medication (including dosage) if any, during the evaluation period and treatment. If medication stability is not possible, the participant's data will be treated separately in the analyses.

The protocol also includes one exclusion criteria that may interfere: (1) having a severe condition that would require being prioritized for treatment, so that an interaction between the two 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, co ffee, and/or nicotine).

## *2.4. Ethics*

All participants who meet the inclusion criteria will sign the personal data protection document before randomization so that they have a notion of whom and for what purpose this study's results will be used. Participants will be also informed of what the treatment consists of before starting it, as well as the duration and phases of the study (informed consent). Direct participation in the study will be voluntary. Participants will not obtain any financial or material compensation, and their participation will not imply any risk for them. The UP has already demonstrated its e fficacy in previous experimental and quasi-experimental studies with di fferent health problems (see "Introduction" section).

Data managemen<sup>t</sup> will be carried out following the Spanish Royal Decree 1720/2008, of 19 January, which approves the Regulations for the development of the Organic Law 15/1999, of 13 December, on the protection of personal data [51]. The treatment, communication, and transfer of personal data will follow the provisions of the Declaration of Helsinki [52] in Law 14/2007 on biomedical research. As of 25 May 2018, the new legislation on personal data in the EU is fully applicable, specifically Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, on Data Protection (GDRP; General Data Protection Regulation). Under the aforementioned legislation, participants can exercise their rights of access, modification, opposition, and cancellation of data, for which they must contact their health professional of reference.

The data collected for the study will be identified by an alphanumeric code, and only the health professionals collaborating in the study will be able to relate these data to the participants and their corresponding medical records. Therefore, the identity of the participants in the study will not be revealed to any person, with exceptions in case of a medical emergency or legal requirement.

The study already has the approval by the Ethical Research Committee of the General University Hospital of Castellón (CEIm; CI/HIP version 1.0 de 20/07/2019). In addition, the protocol study has been registered at https://clinicaltrials.gov/ (6 March 2020; NCT04421443).

## *2.5. Measures*

The evaluation protocol will be administered online by Qualtrics survey [45] at five di fferent moments: pre-treatment, baseline, treatment, post-treatment, and follow-ups every three months until two years after the intervention. Assessment instruments will include demographic characteristics (age, sex, education, marital status, and employment status), a diagnostic interview, and well-established questionnaires for both primary and secondary outcomes. Next, the primary and secondary outcomes that will be evaluated at the pre, post-treatment, and follow-up periods will be described, and later the specific measures that will be used for the baseline evaluation and during the treatment will be specified. Table 3 shows the distribution of the measures that will be administered during the study.


**Table 3.** Distribution of the variables administered throughout the intervention.

Note: MINI: International Neuropsychiatric Interview; BDI-II: Beck Depression Inventory-II; BAI: Beck Anxiety Inventory; BMI: Body Mass Index; PANAS: Positive and Negative Affect Scale; NEO-FFI: NEO Five-Factor Inventory; QLI: Quality of Life Index; MI: Maladjustment Inventory; DERS: Di fficulties in Emotion Regulation Scale; BEAQ: Brief Experiential Avoidance Questionnaire; PHLMS: Philadelphia Mindfulness Scale; ERQ: Emotion Regulation Questionnaire; BITE: Bulimic Investigatory Test; BSQ: Body Satisfaction Questionnaire; EES: Emotional Eating Scale; OASIS: Overall Anxiety Severity and Impairment Scales; ODSIS: Overall Depression Severity and Impairment Scales; OESIS: Other Emotions Severity and Impairment Scale; PESIS: Positive Emotion Severity and Impairment Scale; STQ: Satisfaction with Treatment Questionnaire. 1 Quarterly follow-ups up to two years after treatment; 2 For more information about the specific items that make up the baseline assessment battery see section "Baseline assessment"; 3 For more information about the specific items that make up the assessment during treatment battery see section "Assessment during treatment".

## 2.5.1. Primary Outcomes

Primary and secondary diagnosis according to the DSM-5 criteria will be evaluated with the International Neuropsychiatric Interview (MINI [50]). Subclinical symptoms of anxiety and depression will be evaluated through the Beck Depression Inventory-II (BDI-II [46,47]) and the Beck Anxiety Inventory (BAI [48,49]). The weight gain or loss of the participants will be evaluated through the Body Mass Index (BMI).

## 2.5.2. Secondary Outcomes

Secondary outcomes can be grouped around: a ffectivity, personality traits, quality of life and interference, emotion regulation, aspects related to surgical complications, eating behaviors and body image, and satisfaction with and evaluation of the treatment received.

To assess a ffectivity, the Positive and Negative A ffect Scale (PANAS [53,54]) will be administered to evaluate positive and negative a ffect. Personality will be measured with the NEO Five-Factor Inventory (NEO-FFI [55]), which o ffers a rapid and general measure of the Big Five personality traits of which we will only assess Neuroticism and Extraversion. The Quality of Life Index (QLI [56]) will be used to evaluate several aspects related to quality of life (i.e., physical disability, emotional well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, social–emotional support, community and services support, personal fulfillment, spiritual fulfillment, and overall quality of life). EuroQol [57,58] is a generic instrument that will be used to measure

health-related quality of life. It has five dimensions (mobility, personal care, daily activities, pain, and anxiety/depression), and a general state of health perceived through a visual analog scale. Similarly, the Maladjustment Inventory (MI [59]) will be used to evaluate the extent to which the subject's current problems impact negatively on different areas of daily life, namely, work, social life, leisure time, relationship with the partner, family life, and overall adjustment in daily activities.

Regarding emotion regulation, it will be assessed using the Difficulties in Emotion Regulation Scale (DERS [60,61]), which presents five dysregulation dimensions: emotional lack of control, emotional rejection, life interference, lack of emotional attention, and emotional confusion. In addition, to assess the different emotion regulation skills that will be trained through the UP, we will use the Brief Experiential Avoidance Questionnaire (BEAQ [62,63]), which is a self-report questionnaire with 15 items that measure experiential avoidance; the Philadelphia Mindfulness Scale (PHLMS [64,65]), which is a 20-item questionnaire that assesses two mindfulness constructs: awareness and acceptance and the Emotion Regulation Questionnaire (ERQ [66,67]), which is a self-report questionnaire commonly used to assess two emotion-regulation strategies: cognitive reappraisal (six items) and expressive suppression (four items).

To assess surgical complications, the professional will be asked to refer the participant to the mental health unit a report describing the course of the operation and the recovery from it. Specific measures related to eating disorders will also be used, such as the Bulimic Investigatory Test (BITE [68,69]), which 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 Body Satisfaction Questionnaire (BSQ [70,71]), which is a self-applied scale used to evaluate the fear of gaining weight, feelings of low self-esteem because of one's appearance, the desire to lose weight, and body dissatisfaction, and Emotional Eating Scale (EES [72]), which is a 25-item self-report assessing a person's tendency to cope with negative affect through eating. Participants' weight will be checked monthly to calculate their body mass index (BMI).

Additionally, we created an ad hoc questionnaire to evaluate the participants' evaluation of and satisfaction with the treatment received, the Satisfaction with Treatment Questionnaire (STQ). The Evaluation of the UP Components section consists of nine items that evaluate the extent to which the participants consider that the UP in general, and each of its components in particular, were useful to help them to regulate their emotions adaptively; the Satisfaction with Treatment section presents seven items that evaluate participants' overall satisfaction with the treatment received. In both sections, higher scores show higher levels of positive evaluation and satisfaction. A total of 12 items will also be added to assess the participants' opinion of the online evaluation through Qualtrics and of the Cisco Webex platform used to carry out the online evaluation. At the end of the questionnaire, six open-ended questions appear in which the participants can qualitatively express their opinion of different aspects of the treatment received and the delivery format.

All measures used in the study have been standardized in Spanish. Administration time is between 30 and 40 min for the MINI and approximately 90 min for the primary and secondary outcomes conjointly.

## 2.5.3. Baseline Assessment

To facilitate the daily baseline assessment, we have summarized in one item the variable we want to evaluate, for example, the emotion regulation strategies. For this purpose, we have chosen the item with the greatest factor load for each variable [73]. Specifically, participants will answer a battery of 19 questions: six questions about the presence and intensity of specific emotions (e.g., happiness, sadness, anxiety); five questions to assess the five subscales of the Difficulties in Emotion Regulation Scale (DERS [60,61]), which are emotional lack of control, emotional rejection, life interference, lack of emotional attention, and emotional confusion (e.g., "During this day, to what extent have you paid attention to your feelings?"); two questions that refer to the two subscales of the Emotion Regulation Questionnaire (ERQ [66,67]), which are reappraisal and suppression (e.g.," During this day, to what extent have you been able to control your emotions by changing the way you think about the situation you were in?"); two questions that refer to the two subscales of the Philadelphia Mindfulness Scale (PHLMS [64,65]), which are acceptance and awareness (e.g., "During this day, when your emotions have changed, to what extent have you been aware of it immediately?"); one question to assess experiential avoidance based on the Brief Experiential Avoidance Questionnaire (BEAQ [62,63]) ("During this day, would you say that one of your biggest goals has been to be free of any painful emotion?"); one question from the Emotional Eating Scale (EES [72]) regarding the impulse to eat as a consequence of having experienced an intense emotion ("During this day, to what extent have you felt the urge to eat as a result of experiencing intense emotions?") and one last question from the Body Satisfaction Questionnaire (BSQ [70,71]), which asks about the extent to which the participant has been satisfied with their body image ("During this day, how satisfied have you been with your body image?").

#### 2.5.4. Assessment during Treatment

The assessment during treatment battery involves continuing to fill in the same baseline questions once a week. In addition, before starting each online session, participants will be asked to fill in an emotional scale to assess its presence, intensity, and interference during the last week. Participants can choose the emotion or emotions that should be assessed. The UP offers four different emotional rating scales: The Overall Anxiety and Depression Severity and Impairment Scales (OASIS; ODSIS [74–76]), Other Emotions Severity and Impairment Scale (e.g., guilt, shame, or anger) (OESIS [77]), and a Positive Emotion Severity and Impairment Scale (e.g., happiness) (PESIS [77]; Supplementary Materials). All of them are used in the UP to help patients to continuously monitor the scores throughout the sessions and their progress over the treatment.

## *2.6. Data Analysis*

The analyses will be carried out with the statistical package IBM SPSS Statistics version 22.0 for Windows [78]. First, the sociodemographic characteristics of the sample will be analyzed with descriptive statistics, calculating the mean and standard deviation of the scores in the different questionnaires administered. Next, a missing-value analysis and the Little Missing Completely At Random (MCAR) test will be performed to determine whether or not the distribution of missing values is random, and therefore whether the last observation made (LOCF) can be used. Internal consistency will be explored using Cronbach's alpha.

As the sample size is expected to be less than 50, the normal distribution of the variables will be verified with the Shapiro–Wilk normality test. Depending on the result of this test, parametric or non-parametric repeated measures analysis will be carried out to verify whether or not the differences in the scores of the variables measured at different times are statistically significant. In case the variables follow a normal distribution, parametric repeated measures analysis will be carried out, specifically the Multivariate Analysis of Variance (ANOVA), and in case the variables do not follow a normal distribution, non-parametric repeated measures analysis will be carried out, specifically the Friedman test. If the repeated measures analysis show statistically significant differences between the evaluation time points, post-hoc comparisons will be carried out to correct the level of significance to avoid increasing the type I error. Thus, regarding adjustment for multiple comparisons, the Bonferroni correction will be carried out in case of having performed parametric analysis, and the Wilcoxon signed rank test in case of having performed non-parametric analysis in the comparison of means. More detailed information on this has been added in the data analysis section, explaining step by step which statistical analyzes will be carried out.

Finally, the Reliable Change Index (RCI), which assesses the clinically significant change obtained to determine in which variables the scores have approached those of the normative sample, will be calculated. A clinically significant change will be considered if the RCI score obtained is equal to or greater than 1.96 [79].

Another aspect that we consider important to analyze is how the participants change their scores in each of the variables evaluated based on the content addressed each module. For this purpose, a visual analysis of the changes in the scores will be carried out, to see how the slopes change in the di fferent phases of the study (evaluation and treatment), and in the di fferent modules within the treatment. This visual analysis has been used in previous studies [21]. To carry out this visual analysis, the data from 19 questions that the participants will fill in weekly will be used.

Attendance at sessions will also be recorded to calculate the attendance rate, which will be used as an indicator of viability and acceptance of treatment by users. For the same purpose, quantitative and qualitative analyses will be carried out. At the quantitative level, the participants' evaluation of and satisfaction with the treatment received will be evaluated using an ad hoc designed questionnaire (see "Measures" section). Qualitatively, participants will be asked to answer six main questions about treatment, and their answers will be analyzed by selecting and classifying the information through a segmentation process, identifying key themes and categories of analysis [80].

## **3. Expected Results**

Based on the reviewed bibliography, the type of design of the present study, the proposed objectives and the characteristics of the intervention that will be carried out, we hope that the results will reveal the feasibility and clinical usefulness of the UP applied in an online group format, in a mental health setting of the national health system for candidates of BS who have at least one diagnosis of ED or emotional symptoms. The concrete results that are expected to reach this conclusion are shown in more detail in Table 4.

**Table 4.** Main expected outcomes. UP: Unified Protocol for the transdiagnostic Treatment of Eds.

#### **Clinical Usefulness of the UP for Bariatric Surgery Candidates**

## **Group Results:**


## **Individual Results:**



#### **In both cases, the expected directions for the di** ff**erent variables are:**


bulimic symptomatology, dissatisfaction with body image and emotional eating.

Feasibility of the UP for Bariatric Surgery Candidates



Reporting of results will follow the Consolidated Standards of Reporting Trials (CONSORT) recommendations, specifically its extension for designs N-of-one Trials [81].

## **4. Discussion**

Obesity and being overweight have become a serious public health problem due to their high prevalence and associated costs [2,9]. EDs are highly present in people with obesity [7], and this can interfere with a commitment to voluntary weight loss [82] and it is also associated with worse post-intervention outcomes [11]. An intervention based on emotion-regulation training could help those patients to achieve both aims, to lose weight before the BS to prevent surgery problems and the

emergence of emotional symptoms after the BS, maintaining their emotional and physical achievements over time. In addition to the clinical implications, the results derived from this study may also have an important economic impact. Thus, health policies and the managing of this health condition in public health settings could be also influenced.

To prove this, longitudinal studies are needed and some limitations regarding the interventions (specific CBT versus transdiagnostic intervention) and the delivery formats (onsite versus online) must be considered. The use of the UP in an online group intervention format in a public mental health setting with people waiting for BS has the following benefits:


Our study also has some limitations. First, some people who are going to undergo BS will prefer individual treatment, which could be a barrier to enroll those participants in our study (e.g., abandonment or decrease in UP satisfaction and e ffectiveness). In this case, it could be explained to the patient that group treatment resulted in greater weight losses than individual treatment, even for those clients with a preference for individual therapy and that matching clients with their preferences for individual or group therapy did not enhance treatment outcome either in terms of weight loss or improvements in psychological functioning [84]. Furthermore, a study in a sample of people with EDs diagnosis attended to in public mental health settings in Spain found that the majority of participants preferred receiving psychological treatment in an individual format, followed by group format, and, rarely, in an online format, so it will be necessary to explain to patients the advantages and disadvantages of receiving psychotherapy through individual, group, or online format to help them to decide whether or not to participate in this study [85]. In this sense, the arguments that must be strengthened to justify a group application, in addition to those mentioned previously, are the possibility of sharing experiences, the opportunity to learn from others and receive comments and support and for the online format, convenience [85]. The second main limitation, is that, due to this being a pilot study, the results must be interpreted with caution, as further RCT studies with greater rigor will be required. In this sense, it should be noted that this kind of study is an advisable cost-e ffective method to preliminarily examine the e fficacy, feasibility and/or implementation of recent intervention programs or applications with di fferent samples [86].

Despite the aforementioned limitations, the present study may have different implications. At the research level, it will be the first pilot study aimed at evaluating the feasibility and clinical utility of an online group format of a transdiagnostic intervention for the treatment of ED in public settings in Spain with people waiting for BS, allowing us to increase the evidence on UP's effectiveness, flexibility, and versatility. At a clinical level, the results of the study will reveal whether UP can improve emotional symptoms in candidates and, therefore, improve the effects of BS in the long term. This would have important implications for patients, as it could achieve much more notable improvements after the intervention, and would serve to prevent relapses that generally appear in the long term around two years after BS.

## **5. Conclusions**

In sum, the present study supports the idea of the need to test new forms of psychological interventions with patients waiting for BS [12]. This would allow us to improve the previous psychopathology, and, therefore, to potentiate the effects of BS in the short and long term [2].

The UP may be a good treatment option, considering that it is directed at EDs (which are the most prevalent in people with obesity problems) [12], and that it allows addressing comorbidity, subclinical symptoms, and unspecified disorders [15].

In addition, its application through an online group format can provide extra advantages, as it allows access to treatment for people with mobility problems, something very common among candidates for BS [31], and also fosters social support among the members of the group [33].

Based on all this, the results of the development of this study may have important implications for the National Health System, which will be able to meet the psychological needs of patients with obesity problems, improving their quality of life before the intervention, and enhancing its results in the long term, which will mean a reduction in costs to the system and more specialized and multidisciplinary care for patients who are in this situation.

**Supplementary Materials:** Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (therapist guide and workbook) are available at https://www.oxfordclinicalpsych.com/view/10.1093/med-psych/9780190685973.001. 0001/med-9780190685973; https://www.oxfordclinicalpsych.com/view/10.1093/med-psych/9780190686017.001.0001/ med-9780190686017. Both Spanish versions are available at https://www.alianzaeditorial.es/libro/manuales/protocolounificado-para-el-tratamiento-transdiagnostico-de-los-trastornos-emocionales-manual-del-terapeuta-david-hbarlow-9788491814795/; https://www.alianzaeditorial.es/libro/manuales/protocolo-unificado-para-el-tratamientotransdiagnostico-de-los-trastornos-emocionales-manual-del-paciente-david-h-barlow-9788491814818/.

**Author Contributions:** Conceptualization, J.O.; methodology, J.O. and A.Q.-O.; description of the analysis, A.Q.-O.; resources, J.O. and V.F.-G.; writing—original draft preparation, A.Q.-O.; writing—review and editing, J.O., A.Q.-O. and V.F.-G.; supervision, J.O.; funding acquisition, J.O. All authors have read and agreed to the published version of the manuscript.

**Funding:** Funding for the study was provided by the Aragon Government (Department of Innovation, Research and University), and the European Regional Development Fund (ERDF) "Building Europe from Aragon" (research team S31\_20D).

**Acknowledgments:** We would like to thank all mental health professionals working at the General University Hospital of Vinaròs in Castellón (Spain) for its commitment to ongoing scientific research in clinical and health psychology.

**Conflicts of Interest:** The authors declare no conflict of interest.
