RecruitingNot ApplicableNCT05569018

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

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


Sponsor

Universitat Jaume I

Enrollment

144 participants

Start Date

Nov 23, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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).

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Interventions

BEHAVIORALBlended 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.

BEHAVIORALFace-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).


Locations(1)

Jaume I University, Castellón, Spain

Castellon, Castellón, Spain

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NCT05569018


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