Clinical trial NCT05569018: Efficacy of a Transdiagnostic Group Treatment for Emotional Disorders Applied in Blended Format: a Controlled Study.
Official title: Efficacy of a Group Treatment Based on Transdiagnostic Perspective for Emotional Disorders and Applied in Blended Format: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorders
Keywords: Cognitive-Behavioral Therapy
Transdiagnostic CBT
Blended CBT
Group CBT
Emotional disorders
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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).

Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)
measure: 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.
timeFrame: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)
Secondary outcomes:
measure: 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.
timeFrame: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)
measure: 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.
timeFrame: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)
measure: 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.
timeFrame: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)
measure: 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.
timeFrame: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)
measure: 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.
timeFrame: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)
measure: 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.
timeFrame: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)
measure: 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.
timeFrame: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)
measure: Change on the Modulate Subscale of the S-DERS (Lavender et al., 2017).
timeFrame: Throughout the treatment (post-modules measure)
Other outcomes:
measure: Score on the Expectations scale (adapted from Borkovec & Nau, 1972).
timeFrame: Pre-treatment
measure: Score on the Opinion scale (adapted from Borkovec & Nau, 1972).
timeFrame: Post-treatment (4 months)
measure: Score on the System Usability Scale (SUS) (Bangor, Kortum & Miller, 2008; Brooke, 1996).
timeFrame: Post-module 1 (1 week), Post-treatment (4 months)
measure: Score on the Working Alliance Inventory short format (WAI-S) (Corbella et al., 2011).
timeFrame: Post-module 3 (3 weeks)
Locations:
Study officials:
affiliation: University of Zaragoza, Teruel Campus
name: Amanda Díaz-García, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jaume I University, Castellón, Spain
name: Noelia Jiménez-Orenga, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Jaume I University, Castellón, Spain
name: Juana María Bretón-López, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jaume I University, Castellón, Spain
name: Azucena García-Palacios, Dr.
role: STUDY_DIRECTOR
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