Efficacy of a Transdiagnostic Group Treatment for Emotional Disorders Applied in Blended Format: a Controlled Study.

Study Overview
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Brief Summary
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This study will consist in a randomized controlled clinical trial (RCT) to test the efficacy of a blended group transversal protocol (BLGr-TP) compared to a face-to-face group transversal protocol (FFGr-TP). The main aims of the study are the following: To analyze the differential efficacy of the BLGr-TP versus the FFGr-TP for the treatment of emotional disorders in aspects of clinical measures, as well as in terms of retention and dropout rate and adherence. To analyze the differential acceptability of the BLGr-TP versus the FFGr-TP for the treatment of emotional disorders. In addition, it is intended to carry out a study of mediators and moderators of the efficacy of both interventions. The established hypotheses in relation to the main goals are: Both treatment modalities (FFGr-TP and BLGr-TP) will achieve improvements in the symptoms of emotional disorders, reflected in the scores of the clinical measures. The BLGr-TP will show equivalent efficacy to the FFGr-TP. The BLGr-TP will show an acceptability comparable to the face-to-face protocol. Both modalities will be well valued by the participants. In both treatment modalities, the changes achieved are expected to be maintained over time (3, 6 and 12 months).

Detailed Description
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Emotional disorders (ED) are among the most common and most disabling psychological disorders. They involve important costs and a high comorbidity between them. A large number of evidence-based treatment programs (EBT) has shown to be effective; however, there is a difficulty regarding their dissemination, being that it is difficult to train clinicians in the different protocols for different disorders, and a difficulty in the management of patients with comorbidity. The transdiagnostic approach and the incorporation of technologies for the administration of the based-Internet treatments can help to overcome these barriers. In this context, blended treatments, that combine face-to-face therapy with online therapy, are gaining prominence, because they exhibit advantages over traditional intervention and over treatments totally self-administered throughout Internet. Otherwise, the application of treatments in group format also allows to provide EBTs at a lower cost, so that both blended format and group format constitute strategies that allow improve the cost-effectiveness binomial. To our knowledge, no studies that integrate blended with group format for apply a transdiagnostic protocol for ED have been published. This study will be a two-arm, parallel-group, randomized controlled clinical trial (RCT) in which participants will be randomly assigned to one of two conditions: 1) Face-to-face group transversal protocol (FFGr-TP) and 2) Blended group transversal protocol (BLGr-TP). To carry it out, a total of 144 patients will be needed. Randomization will be stratified by primary diagnosis. Block randomization will be performed within each stratum to ensure that all major diagnoses are equally represented under all conditions. In this trial there will be five evaluation moments: pre-treatment, post-treatment and follow-up at 3, at 6 and at 12 months. During the treatment administration, two messages of support (an email and a SMS) per week will be sent to participants. The study will be carried out following national and international standards (Declaration of Helsinki and Tokyo, and Declaration of Madrid of the World Psychiatric Association) and has been submitted to the approval of the Research Ethics Committee of the Universitat Jaume I. Participants will be adult people who contact with the Psychological Assistance Service (PAS) of the Universitat Jaume I or who write at email enabled for the study. All participants will be volunteers and they will give their informed consent to participate in the study. The confidentiality and rights of the subjects included in the study will be guaranteed in accordance with the provisions of Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of the digital rights (LOPDgdd), which adapts Spanish legislation to the General Data Protection Regulation of the European Union (RGPD).

Official Title
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Efficacy of a Group Treatment Based on Transdiagnostic Perspective for Emotional Disorders and Applied in Blended Format: a Randomized Controlled Trial.

Conditions
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Anxiety Disorders, Depressive Disorders

Intervention / Treatment
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* Behavioral: Blended group transversal protocol (BLGr-TP)
* Behavioral: Face-to-face group transversal protocol (FFGr-TP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being 18 years old or more. DSM-5 (APA, 1013) diagnostic criteria for emotional disorder (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, major depressive disorder, dysthymia, obsessive-compulsive disorder, non-specified anxiety disorder, non-specified depressive disorder). Good understanding of Spanish. Access to the Internet and email address. Informed consent to participate. Exclusion Criteria: Diagnosis of a severe mental disorder (psychotic disorder, bipolar disorder, substance and/or alcohol dependence). High risk of suicide. Having a serious medical illness or other condition that prevents treatment from being carried out. Receiving another psychological treatment during the study period. Changes and/or increases in pharmacological treatment during the study period (a decrease is accepted).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blended group transversal protocol (BLGr-TP)<br>Treatment protocol based on the transdiagnostic perspective administered in blended (face-to-face + online) and group format. It consists of the following components: Psychoeducation about emotional disorders and emotion regulation; Motivation for change; Psychoeducation about emotions; Awareness of emotional experiences; Promotion of cognitive flexibility; Psychoeducation and awareness of avoidance strategies that maintain emotional problems; Interoceptive exposure: exposure to physical sensations; Situational and emotional exposure; Learning to move on; Learning to enjoy; Learning to live; Living and learning; Relapse prevention. | Behavioral: Blended group transversal protocol (BLGr-TP)<br>* It will consist in the administration of a transdiagnostic treatment protocol composed by 16 modules focused on regulating both negative and positive affect. The intervention will be administered over a 16-week period. Face-to-face group sessions will be combined with autonomous work of patients through a web platform where they will find the contents of the program. The groups will have 6-10 patients, who will attend a total of 8 face-to-face sessions of 2 hours long each one. The online part of the treatment (self-applied Online Transversal Protocol) will consist in working the contents exposed in the face-to-face sessions during between-sessions period (2 weeks). It is an interactive program with multimedia elements (videos, images,…) that allows people to perform the modules from home and at their own pace. In addition, the program is characterized by its ease of use, presenting an agile navigation.<br>* Other names: BLGr-TP;|
| Active Comparator: Face-to-face group transversal protocol (FFGr-TP)<br>Treatment protocol based on the transdiagnostic perspective administered in traditional (face-to-face) group format. It consists of the following components: Psychoeducation about emotional disorders and emotion regulation; Motivation for change; Psychoeducation about emotions; Awareness of emotional experiences; Promotion of cognitive flexibility; Psychoeducation and awareness of avoidance strategies that maintain emotional problems; Interoceptive exposure: exposure to physical sensations; Situational and emotional exposure; Learning to move on; Learning to enjoy; Learning to live; Living and learning; Relapse prevention. | Behavioral: Face-to-face group transversal protocol (FFGr-TP)<br>* It will consist in the administration of the transdiagnostic treatment protocol through the 16 modules focused on regulating both negative and positive affect. The intervention will be carried out in face-to-face group format and it will be administered during a 16-week period. The groups will have between 6 to 10 patients, who will attend a total of 16 face-to-face sessions of 2 hours long each one. During between-sessions period (1 week), patients will work the content of the modules exposed in the face-to-face sessions through tasks for home (traditional paper format).<br>* Other names: FFGr-TP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Overall Anxiety Severity and Impairment Scale (OASIS) (Campbell-Sills et al., 2009; González-Robles et al., 2018) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The OASIS is a 5-item self-report scale that evaluates the frequency and severity of anxiety symptoms, the functional impairment related to these symptoms (i.e. school, work, home, or social impairment), and behavioral avoidance. Each item instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4, added together to obtain a total score ranging from 0 to 20. Previous studies have shown good internal consistency (α = 0.80), test-retest reliability, and convergent and discriminant validity. The Spanish version has shown good internal consistency (α = 0.86), and convergent and discriminant validity. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | 
| Change in the Overall Depression Severity and Impairment Scale (ODSIS) (Bentley et al., 2014; Mira et al., 2019) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The ODSIS is a brief self-reported scale with 5 items that assess the severity and functional impairment associated with depressive symptoms. Items are coded on a 5-point scale (0-4). The sum of the scores is used to obtain the total score, which can be a maximum of 20. The measure has shown excellent internal consistency (α = 0.94 in an outpatient sample, 0.92 in a community sample, and 0.91 in a student sample) and good convergent/discriminant validity. The Spanish validation has excellent internal consistency (α = 0.93), as well as convergent and discriminant validity. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Positive and Negative Affect Schedule (PANAS) (Watson, Clark & Tellegen, 1988; Sandín et al., 1999; Díaz-García et al., 2020) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). It contains 10 descriptors evaluating PA (e.g., enthusiastic, inspired, proud) and 10 others assessing NA (e.g., scared, irritable, guilty). The range for each scale (10 items on each) is from 10 to 50, and the patient has to answer how he or she usually feels regarding each of these emotions. The scale showed excellent internal consistency (α between .84 and .90) and convergent and discriminant validity. The Spanish version has demonstrated good to excellent internal consistency (α = .89 and .91 for PA and NA in women, respectively, and α = .87 and .89 for PA and NA in men, respectively) in college students. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | 
| Change in the Difficulties in Emotion Regulation Scale (DERS) (Gratz & Roemer, 2004; Hervás & Jódar, 2008) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The DERS is a self-report scale that assesses different clinically relevant aspects of maladaptive emotional regulation and the main difficulties that may arise in the processing of emotions. In the Spanish adaptation of the scale, the factorial analysis showed five interpretable factors, one less than the original scale: Emotional lack of control (Impulsivity and No strategies of the original scale), Emotional rejection (No acceptance), Everyday interference (No goals), Emotional inattention (No awareness) and Emotional confusion (No clarity). The Spanish validation consists of 28 items with a 5-point Likert scale, being 1 = Almost never (0-10% of the time) and 5 = Almost always (90-100% of the time). The adapted scale has good psychometric properties: internal consistency of 0.93, test-retest reliability of 0.74 and good convergent and incremental validity. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | 
| Change in the NEO-Five Factor Inventory (NEO-FFI) (Costa & McCrae, 1992; Robins, Fraley, Roberts & Trzesniewski, 2001; Aluja, García, Rossier & García, 2005) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The NEO-FFI is the short version of the NEO-PI-R, designed to assess the five personality dimensions through 60 items. In this study, only the subscales of neuroticism and extraversion are used. Each scale contained 12 items with a five-point Likert response format. Two-week retest reliability is uniformly high, ranging from 0.86 to 0.90 for the five scales, and internal consistency ranges from 0.68 to 0.86. The Spanish version of the NEO-FFI has been found to be appropriate. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | 
| Change in the Quality of Life Index (QLI) (Mezzich, Cohen, Ruiperez, Benzato & Zapata-Vega, 2011; Mezzich et al., 2000) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The QLI is a self-report questionnaire that consists of 10 items aimed at assessing quality of life in ten areas: psychological well-being, physical well-being, emotional and social support, interpersonal functioning, selfcare and independent functioning, community and service support, occupational functioning, self-realization, spiritual satisfaction, and an overall assessment of quality of life. The Spanish version of the QLI has shown good internal consistency and test-retest reliability in previous studies. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | 
| 7. Change in the Work and Social Adjustment Scale (WSAS) (Echezarraga et al., 2018; Mundt et al., 2002) at pre-treatment, post-treatment and at 3 and 12-month follow-up. | The WSAS is a 5-item scale that evaluates the degree of interference associated with the patients' symptoms in the following five domains: work, home management, private leisure, social leisure, and family relationships. Items are coded on a scale from 0 (not at all) to 8 (very severely), and higher scores are indicative of greater interference in the different areas. The scale has shown good to excellent internal consistency (α = 0.70 to 0.94), test-retest reliability, and sensitivity to change. The Spanish version has demonstrated excellent internal consistency and good concurrent validity. | Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive-Behavioral Therapy, Transdiagnostic CBT, Blended CBT, Group CBT, Emotional disorders