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

NCT05569018 | Recruiting DMC

• 1 other identifier: UJaumeI_Transd_Group_Blended_2
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Anxiety Disorders; Depressive Disorders

Keywords

Cognitive-Behavioral Therapy; Transdiagnostic CBT; Blended CBT; Group CBT; Emotional disorders

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)

Secondary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)

Other Outcomes (4)

• Score on the Expectations scale (adapted from Borkovec & Nau, 1972).

  Pre-treatment

• Score on the Opinion scale (adapted from Borkovec & Nau, 1972).

  Post-treatment (4 months)

• Score on the System Usability Scale (SUS) (Bangor, Kortum & Miller, 2008; Brooke, 1996).

  Post-module 1 (1 week), Post-treatment (4 months)

Study Arms (2)

Blended group transversal protocol (BLGr-TP)

EXPERIMENTAL

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)

Face-to-face group transversal protocol (FFGr-TP)

ACTIVE COMPARATOR

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)

Interventions

Blended group transversal protocol (BLGr-TP) BEHAVIORAL

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

Blended group transversal protocol (BLGr-TP)

Face-to-face group transversal protocol (FFGr-TP) BEHAVIORAL

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

Face-to-face group transversal protocol (FFGr-TP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Jaume I University, Castellón, Spain

Castellon, Castellón, 12071, Spain

RECRUITING

Related Publications (32)

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Related Links

• Web platform of self-applied treatment

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Study Officials

• Amanda Díaz-García, Dr.

  University of Zaragoza, Teruel Campus

  PRINCIPAL INVESTIGATOR

• Noelia Jiménez-Orenga, PhD student

  Jaume I University, Castellón, Spain

  PRINCIPAL INVESTIGATOR

• Juana María Bretón-López, Dr.

  Jaume I University, Castellón, Spain

  PRINCIPAL INVESTIGATOR

• Azucena García-Palacios, Dr.

  Jaume I University, Castellón, Spain

  STUDY DIRECTOR

Central Study Contacts

Juana María Bretón-López, Dr.

CONTACT

+34 964387642; breton@uji.es

Azucena García-Palacios, Dr.

CONTACT

+34 964387640; azucena@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: October 6, 2022
• Study Start: November 23, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

ES (1)