An interventional study of Blended group transversal protocol (BLGr-TP) and Face-to-face group transversal protocol (FFGr-TP) in Anxiety Disorders and Depressive Disorders, sponsored by Universitat Jaume I. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Universitat Jaume I · Not applicable, Interventional, and Treatment
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:
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:
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).
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 144 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Universitat Jaume I is the lead sponsor of 79 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
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)
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)
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.
Also known as: BLGr-TP
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).
Also known as: FFGr-TP
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-, 6- 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.
Time frame: Pre-treatment, post-modules (throughout the 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-, 6- 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.
Time frame: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)
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-, 6- 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.
Time frame: Pre-treatment, post-modules (throughout the 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-, 6- 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.
Time frame: 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-treatmen,t and at 3-, 6- 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.
Time frame: 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-, 6- 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.
Time frame: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)
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-, 6- 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.
Time frame: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)
Change on the Multidimensional Emotional Disorders Inventory (MEDI) (Rosellini & Brown, 2019; Osma et al., 2023) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up.
It is a self-report questionnaire that assesses nine transdiagnostic dimensions (Neurotic Temperament, Positive Temperament, Depressive Mood, Autonomic Arousal, Somatic Anxiety, Social Anxiety, Intrusive Thoughts, Traumatic Re-experiencing and Avoidance). It consists of a 49-item scale with a 9-point Likert-type response (from 0 = "It is not characteristic of me" to 8 = "Totally characteristic of me"). The Spanish validation shows good psychometric properties and strong internal consistency indices (α = 0.66 to 0.91).
Time frame: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)
Change on the General Self-Efficacy Scale (GSES) (Baessler y Schwarzer, 1996; Sanjuán et al., 2000) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up.
It assesses the stable feeling of personal competence to effectively handle a wide variety of stressful situations. It consists of 10 items with 10-point Likert-type scales, so that subjects' scores can range from 10 to 100.
Time frame: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)
Change on the Modulate Subscale of the S-DERS (Lavender et al., 2017).
The S-DERS is a measure of difficulties in state emotional regulation, to assess momentary emotional regulation. Factor 2 (Modulate) includes items that reflect difficulties in responding emotionally and behaviorally in the moment, and was labeled as Limited Ability to Modulate Current Emotional and Behavioral Responses. This factor conceptually overlaps with the Strategies, Impulse, and Goals subscales of the original trait DERS, combining difficulties in modulating both emotions and behavioral responses to emotions into a single state scale. The Modulate subscale demonstrated adequate to excellent internal consistency (α=0.85). Regarding validity, the Modulate subscale was positively associated with measures of experiential avoidance, with measures of substance use problems, and with emotional reactivity.
Time frame: Throughout the treatment (post-modules measure)
Score on the Expectations scale (adapted from Borkovec & Nau, 1972).
This scale is made up of five items, rated on a scale from 0 (nothing at all) to 10 (completely), that cover how logical the treatment seems to be, to what extent it could satisfy the patient, whether it could be recommended to a person with the same problem, whether it could be used to treat other psychological problems, and its usefulness for the patient's problem. The Expectation Scale is applied once the treatment rationale has been explained. Its aim is to measure subjective patient expectations about this treatment.
Time frame: Pre-treatment
Score on the Opinion scale (adapted from Borkovec & Nau, 1972).
This scale is made up of five items, rated on a scale from 0 (nothing at all) to 10 (completely), that cover how logical the treatment seems to be, to what extent it could satisfy the patient, whether it could be recommended to a person with the same problem, whether it could be used to treat other psychological problems, and its usefulness for the patient's problem. The Opinion Scale is administered when the patient has completed the treatment, and its aim is to assess satisfaction with this treatment.
Time frame: Post-treatment (4 months)
Score on the System Usability Scale (SUS) (Bangor, Kortum & Miller, 2008; Brooke, 1996).
The SUS is applied in order to assess the usability of a service or product and the acceptance of technology by the people who use it. The SUS is a simple, ten-item scale that indicates the degree of agreement or disagreement with the statements on a 5-point scale (1 = strongly disagree, 5 = strongly agree). The final score is obtained by adding the scores on each item and multiplying the result by 2.5. Scores range from 0 to 100, where higher scores indicate better usability.
Time frame: Post-module 1 (1 week), Post-treatment (4 months)
Score on the Working Alliance Inventory short format (WAI-S) (Corbella et al., 2011).
The WAI-S maintains the three subscales of the WAI and consists of 12 items to be answered on a 7-point Likert scale where the lower polarity is "never" and the upper polarity is "always". Each subscale (Goals, Tasks and Bond) is evaluated by 4 items. Thus, the total score of the WAI-S can range from 12 to 84 points.
Time frame: Post-module 3 (3 weeks)
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