*Article*

## **Feasibility and Clinical Usefulness of the Unified Protocol in Online Group Format for Bariatric Surgery Candidates: Study Protocol for a Multiple Baseline Experimental Design**

#### **Alba Quilez-Orden 1,2, Vanesa Ferreres-Galán 3 and Jorge Osma 1,2,\***


Received: 25 June 2020; Accepted: 20 August 2020; Published: 25 August 2020

**Abstract:** Obesity is currently becoming a serious global public health problem due to its high prevalence and continuous increase. This condition is associated with different physical and mental health problems. The presence of emotional disorders (anxiety, depression and related disorders) among candidates for bariatric surgery is very high and predicts worse physical and psychological results. The present study aims to explore the feasibility and clinical usefulness of the Unified Protocol, a transdiagnostic emotion regulation-based intervention, delivered in an online group format to patients with emotional disorder diagnosis or symptoms, who are waiting for bariatric surgery. 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 60 participants, who will be randomized to three baseline conditions: 8, 12 or 15 evaluation days before the intervention. Diagnostic criteria, symptomatology and body mass index are the primary outcome measures, and we will include affectivity, personality, quality of life, body image, eating behavior and surgical complications like secondary measures. An analysis of treatment satisfaction will be also performed. Assessment points will include pre-treatment, baseline, treatment, post-treatment, and follow-ups every three months until two years after post-treatment. The results obtained in this study may have important clinical, social and economic implications for public mental health.

**Keywords:** emotional disorders; transdiagnostic; online group format; unified protocol; bariatric surgery; obesity

## **1. Introduction**

Obesity is a chronic disease characterised by an increase in body fatness, which is usually estimated by body mass index (BMI) calculated as measured body weight (kg) divided by measured height squared (m2) [1]. Obesity is currently becoming a serious global public health problem due to its high prevalence and increase in recent years [2]. In Spain alone, 25% of the population is obese or overweight, and the expectations are alarming. It is expected that in 2030, up to 80% of Spanish men and 55% of women will be obese or overweight, exceeding 27.2 million of people [3].

The causes of obesity are complex and multifactorial [1], and this condition is associated with different health problems, such as myocardial infarction, hypertension, stroke, dyslipidemia, diabetes mellitus, or obstructive sleep apnea [4–6]. All these alterations affect the quality of life and can disturb important areas of functioning (e.g., physical function, vitality, social functioning and emotional role) [7,8]. In addition to all of these complications, people with obesity experience significant psychological difficulties [7]. Due to all of these health implications, obesity represents a challenge to

the countries' economies [9]. As of 2016 in Spain, the obesity cost meant almost two billion euros of extra expenses for the National Health System [3].

For all these reasons (high prevalence and associated costs), many efforts have been made to find treatments for obesity and weight loss, which include lifestyle interventions, pharmacological interventions, surgical interventions, and endoscopic bariatric procedures [7]. Bariatric surgery (BS) is the most commonly performed procedure worldwide [10] and the most effective intervention for individuals with severe obesity (BMI greater than 40 kg/m2) [11], and includes a group of surgical procedures performed to facilitate weight loss, such as open or laparoscopic roux-en-Y gastric bypass, sleeve gastrectomy, and adjustable gastric banding. The most obvious and studied benefits of BS refer to physical issues, specifically weight loss and improvement of obesity-related physical comorbidities; however, between 10% and 25% of patients who undergo BS show suboptimal weight loss, and it is estimated that they regain approximately 10% of their weight during the first decade after the intervention [12]. Regarding the psychological benefits of BS, limited and inconclusive results have been found [13]. Some systematic reviews have reported improvements after BS, especially in depressive symptoms, but also limited only to the first months after the intervention, and they tend to reappear after the first two years [10].

Some studies have questioned whether previous psychopathology history could influence the results obtained by BS [2]. This topic is especially relevant because the percentage of psychopathology among people waiting for BS (between 20.9% and 55.5%) [12] is much higher than in the general population (between 12.53% and 13.87%) [14]. Specifically, the group of emotional disorders (ED), which includes anxiety and mood disorders, eating disorders, and related disorders ([15]; Supplementary Materials), are the most prevalent disorders among BS candidates: eating disorders (50%), mood disorders (31.5%), anxiety disorders (24%), and substance use related disorders (10%) [12]. It has been concluded that the presence of EDs among candidates for BS predicts worse results in the long term [11], furthermore, a meta-analysis states that the prevalence of suicide mortality is up to 1.8%, and the prevalence of suicide is up to 0.3% after bariatric surgery [16].

As we can observe, psychological evaluation and intervention play a fundamental role in the multidisciplinary work performed with these patients before and after BS although, until now, it has not received much attention [12]. Improvements in eating psychopathology (e.g., binge eating, emotional eating, body image dissatisfaction) have been reported from psychological interventions using psychoeducation, goal setting, self-monitoring, normalized eating, stimulus control, cognitive restructuring, and relapse prevention [11]. Cognitive–behavioral therapy (CBT) is the one that accumulates the most evidence of the improvement of eating behaviors (e.g., binge eating and emotional eating) and psychological functioning (e.g., quality of life, depression, and anxiety symptoms) [11]. Despite the good outcomes achieved, these CBT interventions have been developed to treat specific disorders (e.g., eating disorders or anxiety disorders), and this fact raises some limitations. First, clinicians' grea<sup>t</sup> effort to specialize in a range of different interventions; second, the increased costs for health systems and clinicians in training, and as a consequence, the difficulties in dissemination and implementation of the CBT interventions [17]. Furthermore, if we consider that the most prevalent disorders among patients with obesity are EDs [12], there are additional limitations to specific CBT interventions. This is because in the case of these disorders, comorbidity is very high, and subclinical symptoms or unspecified disorders usually arise [18]. These comorbid conditions make it even more difficult to choose the best specific CBT treatment in each case [19].

To address all the limitations of the specific CBT treatments previously discussed, in recent years, different CBT interventions from a transdiagnostic approach have been developed and tested. In this sense, the Unified Protocol for the transdiagnostic treatment of EDs (UP) is a CBT emotion-based intervention designed to treat the etiological and maintenance mechanisms shared by all EDs [20]. This intervention focuses on a wide range of emotional psychopathology, considering comorbid disorders and subclinical or unspecified symptoms, reducing treatment times and costs, and improving response to treatment [17].

The UP is made up of eight treatment modules, five of which are considered core modules because they are focused on training di fferent specific emotion-regulation skills [21]. Despite that the UP is a protocolized intervention, it is also flexible and versatile, allowing clinicians to use some of the modules or to change modules' order to personalize the UP to their patients [22]. Its main objective is to enhance emotion-regulation strategies to all people presenting emotional dysregulation problems [15]. To date, the UP has shown a significant improvement in pre-treatment symptoms and has obtained effect sizes that are at least comparable to existing specific CBT interventions, in on-site and online formats [23]. Beyond the mood or anxiety disorders per se, the UP has been applied to di fferent health problems, such as cancer [24], HIV [25], or irritable bowel syndrome [26]. Despite the positive data on the e ffectiveness of the UP for the treatment of EDs in di fferent health conditions, we have found no studies about its clinical utility to improve anxiety and depressive symptoms or EDs in patients with obesity who are waiting for BS.

As mentioned, the UP can be applied in various formats, such as onsite or online (both individual and group). Regarding online interventions in mental health (e-Health), there is an important amount of evidence over the last 15 years informing that online treatments are e ffective to treat a wide range of mental health disorders and that they can be as e ffective as onsite treatments [27]. We also know that online interventions do not negatively a ffect the therapeutic relationship [28] and that the users generally show high levels of acceptance and satisfaction with this delivery format [29]. The use of Information and Communication Technologies (ICTs) reduces the burden on health professionals and users, facilitating data collection and accessibility to Treatment [30]. In fact, di fferent studies have shown the need to develop technology-based interventions to increase accessibility to treatment for BS candidates because their obesity condition significantly a ffects their mobility, and that makes it di fficult for them to attend weekly sessions on-site [31]. Another practical benefit of delivering online psychological interventions is related to the current situation caused by the Covid-19 pandemic because the online format (e.g., emails, videoconference, etc.) will allow phycologists to continue their interventions and/or the follow-up assessments in case of new mobility restrictions [32]. Finally, the online group format can o ffer additional advantages to the online format itself, as it facilitates social support among the participants in the therapy and also allows them to share experiences and learn from each other [33].

Therefore, the general objective of this study is to analyze the feasibility and clinical usefulness of the UP, applied in an online group format, in a mental health setting of the National Health System to candidates for BS who have at least one diagnosis of ED or emotional symptoms.

The specific objectives pursued are: to evaluate adherence to treatment and clinical improvement in the primary and secondary measures after applying the UP and to study its long term clinical usefulness until two years after the intervention. Thus, the main hypotheses proposed for this study are: (1) statistically significant di fferences (reliable change index; RCI) will be obtained between the scores obtained at the pre-treatment, baseline, and post-treatment on the primary and secondary measures; (2) the improvements obtained after the application of the UP will be maintained in the long term (follow-ups of up to two years); (3) participants in the pilot study will report high adherence rates and high satisfaction scores regarding the treatment delivery format and its components.

#### **2. Materials and Methods**

This is a pilot study using a repeated single-case experimental design (multiple baseline design) to explore the feasibility and clinical usefulness of a transdiagnostic emotion-based online group intervention (UP) for BS candidates with EDs or subclinical anxious or depressive symptoms attended to in a public mental health service. We have chosen this design for three reasons: (1) the unit of intervention and unit of data analysis is an individual case, specifically a cluster of participants; (2) the case provides its own control for comparison purposes because a number of variables are measured before the intervention and compared with measures during and after the intervention and (3) the variable is repeatedly measured within and across di fferent conditions or levels of the independent variable. Furthermore, and because our main objective is to answer the question "Is the Unified Protocol able to improve the emotional state of people waiting for BS?", we chose a multiple baseline design to improve experimental control throughout replication, introducing the independent variable at di fferent points in time. The fundamental idea of choosing this type of design is that each of the participants can be their own control group [34].

The multiple baseline design involves the application of the treatment variable in a staggered way over time, through di fferent observational units. This design is suitable for health services research interventions that are focused on changing patient behavior. This methodology facilitates a systematic comparison of pre-intervention and post-intervention measures [35], and conducting a preliminary assessment of a novel intervention [36]. Like randomized controlled trials (RCTs), the multiple baseline design can demonstrate that a significant change in behaviour has occurred and that is result of the intervention. One of the main limitations is that each participant must show changes only when the intervention is applied, and this issue, at a practical level is complicated, can make it di fficult for the researcher to draw clear conclusions about the impact of the intervention. In order to reduce this limitation and improve the internal validity, researchers start treatment at di fferent times across settings, behaviors, or people [37]. The multiple baseline design has advantages over the RCTs because this design requires fewer population groups and communities and they may act as their own controls [35]. In this sense, researchers often use this design with several people at once addressing the issue of external validity [37].

In the present investigation, all consecutive patients who are selected to undergo BS and who present anxiety or depressive symptoms or at least one diagnosis of ED, will be asked to participate. Once inclusion criteria are met (see "Inclusion and exclusion criteria" section), each patient will be randomly assigned to one of the multiple baseline conditions: 8, 12, or 15 evaluation days before the intervention. These multiple baseline conditions have been chosen following the current guides for single-case designs [34,38].

A random assignment will be carried out to reduce the threat of selection, and the fact of choosing three conditions is one of the established standards for this type of designs in order to reduce the threat of ambiguous temporal precedence and maturation [38]. Furthermore, the fact that all three conditions involve evaluation periods of 8, 12 and 15 days is due to the established standard of having a minimum of five data points in each phase to reduce the threat of attrition [38]. By choosing at least eight, we make sure to meet it even considering the probability that participants will forget to fill out the assessment one day. Actually, the reason for choosing those days is the temporal stability of the variables that we measured through the study.

In addition, the intervention will begin in a staggered manner with individual sessions (to reduce the threat of the history) and to reduce the threat of testing, a pre-treatment assessment will be performed prior to starting the baseline, to consider that the assessment process itself can have therapeutic e ffects on participants [38].

The study includes five assessment moments (pre-treatment, baseline, treatment, post-treatment, and follow-up, one every three months until two years after treatment completion). The flow chart of the study design is shown in Figure 1.

**Figure 1.** Study flow chart. BS: Bariatric surgery.

#### *2.1. Sample and Recruitment*

The study recruitment will start in September 2020 until December 2024. The study will be conducted in a public mental health center in Spain (Mental Health Unit of the Regional Hospital of Vinaròs, Castellón). Participants will be people over 18 years of age who have anxious or depressive symptoms, or at least one diagnosis of EDs according to Diagnostic and Statistical Manual of Mental Disorders five edition criteria [39] and who have been selected for a subsequent BS.

To calculate the sample size, we drew on a study that proposed stepwise rules of thumb for pilot studies based on the target effect size and the size of the future trial [40]. Previous works that study the efficacy of CBT procedures either in person or online have shown large variations in effect sizes, obtaining mainly medium to large effect sizes [41,42]. Taking these data into account, and expecting a 90% powered main trial and assuming a sample loss of 35% [43] we established a sample

size of 20 participants per experimental condition for the present study, that is, a total sample of 60 participants.

## *2.2. Procedure*

The participants who are referred to the mental health unit for having fulfilled the requirements to be candidates for BS, will be evaluated to see if they meet the rest of the inclusion criteria for this study. In Table 1, it can be seen the selection criteria used to choose the appropriate candidates to receive the BS. These criteria are based on the European Guidelines for Obesity Management in Adults, which indicates that a comprehensive obesity managemen<sup>t</sup> can only be accomplished by a multidisciplinary obesity managemen<sup>t</sup> team [44].

> **Table 1.** Inclusion criteria and main contraindications for BS.


