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

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

Interventions

BEHAVIORAL

Blended group transversal protocol (BLGr-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.

BEHAVIORAL

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

Sponsors & Collaborators

• Universitat Jaume I

  lead OTHER

Principal Investigators

• Amanda Díaz-García, Dr. · University of Zaragoza, Teruel Campus

• Noelia Jiménez-Orenga, PhD student · Jaume I University, Castellón, Spain

• Juana María Bretón-López, Dr. · Jaume I University, Castellón, Spain

• Azucena García-Palacios, Dr. · Jaume I University, Castellón, Spain

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-23

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• Spain

Study Locations